[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CSPC Megalith Biopharmaceutical Co.,Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":536},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,33,0,25,[9,42,63,86,106,126,148,172,191,212,230,250,271,291,311,333,353,374,395,415,435,456,476,496,517],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100652593","phase-1-a-study-of-syh2092-injection-in-healthy-participants-100652593",false,"NCT07776041","A Study of SYH2092 Injection in Healthy Participants","Inclusion Criteria:\n\n1. Fully understand the content, process and possible adverse drug reactions (ADRs) of the study before the study, and voluntarily sign the ICF;\n2. At Screening, aged 18 to 60 years (inclusive, based on the date of signing the ICF), including both males and females;\n3. At Screening, body weight ≥ 50 kg with a body mass index (BMI) of 18 to 35 kg\u002Fm²\n4. Body weight change ≤ 5% within 3 months prior to Screening (including the Screening Period) (based on participant self-report);\n5. Participants (including their partners) have no birth plan from signing the ICF until 6 months after the last dose, and agree to use highly effective contraceptive measures as stipulated in the protocol.\n\nExclusion Criteria:\n\n1. Known or suspected allergy to amylin receptor agonists or any component of the investigational product; or those with an allergic constitution (allergy to multiple drugs and foods);\n2. Clinically significant abnormal results in vital signs, physical examination, laboratory tests, or ECG, as judged by the Investigator, that render the participant unsuitable for the study. The following conditions do not lead to exclusion: (1) TG ≤ 3.42 mmol\u002FL, TC ≤ 7.5 mmol\u002FL, HDL-C abnormal; (2) alanine aminotransferase (ALT) \\\u003C 1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) \\\u003C 1.5 × ULN, or total bilirubin \\\u003C1.5 × ULN;\n3. HbA1c ≥ 6.5% during Screening Period, or fasting glucose \\\u003C 3.9 mmol\u002FL or ≥ 7 mmol\u002FL;\n4. Prolonged QTcF interval during Screening Period (≥ 450 ms for males; ≥ 460 ms for females; see Section 13.5 for calculation formula), history of risk factors for Torsades de Pointes (e.g., cardiac failure\u002Fcardiomyopathy, or family history of long QT syndrome);\n5. Positive for any of the following: Hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema antibody.\n6. Significant history or clinical manifestation of any metabolic, dermatological, hepatic, renal, hematological, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, immune or psychiatric disorder that, in the opinion of the Investigator, may place the participant at increased risk or interfere with study assessments. This does not include: resolved childhood asthma; mild intermittent asthma; seasonal allergic rhinitis; eczema with no use of topical steroid creams within 3 months prior to Screening; fully resolved gestational diabetes; or Gilbert's syndrome;\n7. Severe trauma or major surgery within 3 months prior to Screening, or plan to undergo surgery during the study; 8）History of malignancy (not including basal cell carcinoma \\[BCC\\], squamous cell carcinoma \\[SCC\\], or carcinoma in situ of the cervix); history of severe\u002Fmajor depressive\u002Fanxiety (not including history of mild\u002Fresolved depressive\u002Fanxiety, as judged by the Investigator); or epilepsy (not including a history of febrile seizures in childhood);\n\n9\\) History of clinical gastric emptying abnormalities (e.g., gastric outlet obstruction) or severe chronic gastrointestinal diseases (e.g., inflammatory bowel disease, active ulcers); history of acute or chronic pancreatitis; or active\u002Fcurrent gallbladder disease (e.g., symptomatic cholelithiasis, cholecystitis). This does not include a history of cholecystectomy for resolved gallbladder disease; 10) History of gastrointestinal surgery that may lead to malabsorption, or long-term use of drugs directly affecting gastrointestinal motility, or other therapies that affect gastrointestinal motility. Examples include: bariatric surgery or procedures (e.g., gastric banding), or use of glucagon-like peptide-1 (GLP-1) receptor agonist, glucose-dependent insulinotropic polypeptide (GIP) receptor agonist, amylin receptor agonists, or drugs\u002Fproducts deemed by the Investigator to cause body weight changes and affect body weight assessment within 3 months prior to Screening (see Section 6.8 for details); This does not include appendectomy or uncomplicated hernia repair, which are permitted; 11) Presence of symptoms or signs of dermatitis or skin abnormalities (including tattoos) at or around the injection site (abdomen), or within 5 cm of the injection site; 12) Use of any prescription drugs within 14 days prior to dosing, or less than 5 half-lives have elapsed since the last use (whichever is longer), with the exception of hormonal contraceptives used for contraceptive purposes as permitted under Section 13.1.2; Use of any over-the-counter (OTC) drugs (excluding topical medications such as creams, ointments, or eye drops), dietary supplements, or herbal medicines within 7 days prior to dosing, or less than 5 half-lives have elapsed since the last use (whichever is longer), except for short-term use of paracetamol and anti-inflammatory drugs within 7 days prior to dosing, at the Investigator's discretion; 13）Use of drugs that may affect glucose metabolism (e.g., systemic steroids, non-selective beta-blockers, monoamine oxidase inhibitors) within 1 month prior to Screening, or less than 5 half-lives have elapsed since the last use of such drugs (whichever is longer); 14) Average weekly alcohol consumption exceeding 21 units (males) or 14 units (females) within 3 months prior to Screening (1 unit ≈ 360 mL of beer with 5% alcohol content, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine with 12% alcohol content), positive breath alcohol test, or inability to abstain from alcohol during the study; 15）Participants who smoked \\> 10 cigarettes\u002Fweek or 2 cigarettes\u002Fday (or nicotine-equivalent, including e-cigarettes\u002Fvaping devices) within 3 months prior to Screening or who cannot stop using any nicotine products (including cigarettes, e-cigarettes\u002Fvaping devices, smokeless tobacco, and nicotine replacement therapy) during the study. A positive cotinine result, or the need for repeat testing, may be permitted at the Investigator's discretion; 16) Average daily consumption of excessive tea, coffee, and\u002For caffeine-containing beverages (more than 8 cups on average, 1 cup ≈ 250 mL) within 3 months prior to Screening, or inability to abstain during the study; 17) Strenuous exercise (e.g., weightlifting, sprinting, long-distance running, cycling, swimming, soccer) within 48 h prior to Screening; 18) History of drug abuse within 3 months prior to Screening, or positive drug abuse screening test. A positive drug abuse screening test result attributable to a documented medical history of prescribed medication may be permitted at the Investigator's discretion, following discussion with the Sponsor, provided the participant is not currently receiving such medication; 19) Has donated whole blood or had a loss of whole blood of more than 500 mL within the 30 days prior to Screening; has donated plasma (plasmapheresis) within 7 days prior to Screening; or has received a blood transfusion within one year prior to Screening; Participants with a history of needle phobia and blood phobia, difficulty in blood collection or intolerance to venipuncture blood collection; 21) Participants who had special dietary requirements and could not accept a uniform diet and rest. The following dietary requirements will be accommodated: dairy\u002Flactose-free, gluten-free, gluten-free and lactose-free, halal, no pork and beef, no red meat, no seafood, pescatarian, standard, vegan, and vegetarian; 22) Females who are pregnant, lactating, or have a positive serum pregnancy test during the Screening Period; 23) Participation in any other clinical study of drugs or medical devices within 3 months or 5 half-lives prior to Screening (whichever is longer), or planned participation in a clinical study of other drugs or medical devices during this study; 24) Participants whom the Investigator judges to have other factors that make them unsuitable to participate in the trial.",true,"ALL","18 Years","60 Years",{"count":21,"type":22},46,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","To evaluate the safety and tolerability of SYH2092 Injection in healthy participants",[28],"Overweight or Obesity","NOT_YET_RECRUITING","2026-08-17",{"date":32,"type":33},"2026-08-20","ACTUAL",{"date":35,"type":22},"2026-09-30",{"date":37,"type":22},"2027-04-20",{"name":39,"class":40},"CSPC Megalith Biopharmaceutical Co.,Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":60,"leadSponsor":62,"locationsCount":41},"100651387","phase-1-evaluate-the-safety-and-efficacy-of-combination-therapy-with-sys6090-injection-for-hepatocellular-carcinoma-100651387","NCT07761286","Evaluate the Safety and Efficacy of Combination Therapy With SYS6090 Injection for Hepatocellular Carcinoma","Phase Ib\u002FII Study to Evaluate the Safety, Tolerability and Efficacy of Combination Therapy With SYS6090 Injection in Participants With Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. The participant voluntarily signs the informed consent form.\n2. Aged ≥18 years at the time of informed consent acquisition.\n3. Confirmed diagnosis of hepatocellular carcinoma (HCC) via histopathology, cytopathology, or clinical diagnosis in accordance with the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2026 Edition).\n4. Barcelona Clinic Liver Cancer (BCLC) Stage C; or BCLC Stage B unsuitable for curative surgery and\u002For locoregional therapy.\n5. Child-Pugh score \\\u003C7 and no history of hepatic encephalopathy.\n6. No prior systemic anti-tumor therapy for HCC. Prior systemic therapy administered in the neoadjuvant or adjuvant setting is permitted, provided that the time from the last dose of prior therapy to tumor recurrence is ≥6 months.\n7. At least one measurable lesion per RECIST Version 1.1. Lesions previously treated with interventional therapy, radiotherapy or ablation may be counted as measurable lesions if clear disease progression is documented per RECIST v1.1 and the lesion meets measurable lesion criteria.\n8. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n9. Expected survival ≥3 months.\n10. Adequate organ function as defined below:\n\n    1. Hematology: PLT ≥100×10⁹\u002FL; Hb ≥90 g\u002FL; ANC ≥1.5×10⁹\u002FL (no blood transfusion, platelet transfusion or hematopoietic stimulating factor administered within 14 days prior to hematology testing at screening);\n    2. Liver function: AST and ALT ≤5×ULN; TBIL ≤1.5×ULN;\n    3. Renal function: Ccr \\>50 mL\u002Fmin (calculated by the Cockcroft-Gault formula); urine protein \\\u003C2+; participants with urine protein ≥2+ must have a 24-hour urine protein quantification \\\u003C1 g;\n    4. Coagulation function: APTT ≤1.5×ULN; INR ≤1.5×ULN. Participants receiving full-dose oral anticoagulants must maintain a stable dose for a minimum of 14 days;\n    5. Albumin: ≥30 g\u002FL (equivalent to ≥3.0 g\u002FdL).\n11. Fertile eligible participants (male and female) must agree to use reliable contraceptive methods together with their partners throughout the study period and for at least 7 months after the last study drug administration (hormonal contraceptives, barrier methods, or abstinence). Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment.\n12. Willing and able to comply with all study requirements.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or mixed hepatocellular-cholangiocarcinoma.\n2. Received any anti-tumor therapy (including chemotherapy, targeted therapy, immunotherapy, etc.) or any investigational trial intervention within 4 weeks prior to the first study drug administration or within 5 half-lives of the most recent anti-tumor agent (whichever is shorter); or received Chinese patent medicines with anti-tumor indications, palliative radiotherapy, or locoregional therapy within 14 days prior to the first study drug administration.\n3. Underwent major visceral surgery (excluding core needle biopsy) or sustained severe trauma within 4 weeks prior to the first study drug administration, or planned elective surgery during the study period.\n4. Received systemic corticosteroids or other immunosuppressive agents within 14 days prior to the first study drug administration, except for the following scenarios: physiologic replacement doses of hydrocortisone or equivalent hormones (i.e., prednisone ≤10 mg\u002Fday or equivalent); topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids; short-course corticosteroids for prophylaxis (e.g., prophylaxis against contrast medium allergy).\n5. Received live vaccines within 4 weeks prior to the first study drug administration. Note: Seasonal influenza vaccines are inactivated vaccines in general and are permitted. Intranasal influenza vaccines are live vaccines and are prohibited.\n6. Received strong CYP3A4 inhibitors\u002Finducers, or OATP1B1\u002FOATP1B3 inhibitors within 14 days prior to the first study drug administration, or require continuous use of such agents throughout the study period.\n7. Adverse reactions from prior anti-tumor therapy have not recovered to Grade ≤1 per NCI CTCAE v6.0 (excluding toxicities judged by the Investigator to carry no safety risks, such as alopecia, Grade 2 peripheral neuropathy, hypothyroidism stabilized with hormone replacement therapy, etc.).\n8. History of or current central nervous system metastases and\u002For carcinomatous meningitis; current untreated spinal cord compression (excluding participants with previously diagnosed treated spinal cord compression with documented clinically stable symptoms for more than 2 weeks prior to screening).\n9. Active infection requiring intravenous anti-infective therapy within 14 days prior to the first study drug administration.\n10. Symptomatic moderate or severe ascites within 14 days prior to the first dose or at screening (excluding minor ascites only visible on imaging without clinical symptoms); or uncontrolled moderate or larger pleural effusion or pericardial effusion.\n11. Tumor thrombus involving both the main portal vein and left\u002Fright portal branches simultaneously; tumor thrombus involving both the main portal vein and superior mesenteric vein simultaneously; or tumor thrombus involving the inferior vena cava.\n12. Esophageal or gastric variceal bleeding secondary to portal hypertension, or any life-threatening bleeding event within 6 months prior to the first study drug administration (including events requiring blood transfusion, surgery, locoregional intervention, or sustained medical treatment); known severe esophageal\u002Fgastric varices on endoscopy without definitive treatment within 3 months prior to the first study drug administration; other gastrointestinal bleeding events, active gastric or duodenal ulcer within 28 days prior to screening.\n13. History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or intestinal obstruction within 6 months prior to the first study drug administration.\n14. Presence of severe unhealed wounds or untreated fractures at screening.\n15. Current interstitial pneumonia\u002Finterstitial lung disease; prior history of interstitial pneumonia\u002Finterstitial lung disease requiring corticosteroid treatment; or other pulmonary conditions that may interfere with the identification and management of immune-related pulmonary toxicity, such as pulmonary fibrosis, organizing pneumonia, active pulmonary tuberculosis, etc.\n16. Active hepatitis B at screening \\[positive HBsAg or HBcAb with active viral replication (HBV DNA ≥2000 IU\u002FmL)\\]; hepatitis C (positive Anti-HCV antibody with positive HCV RNA PCR); active syphilis infection (positive TP-Ab plus positive TRUST\u002FRPR); HIV infection; or concurrent co-infection with both hepatitis B and hepatitis C.\n17. History of severe cardiovascular and cerebrovascular diseases, including but not limited to:\n\n    1. NYHA Class II or higher congestive heart failure, unstable angina, or myocardial infarction occurring within 6 months prior to the first study drug administration;\n    2. Severe cardiac rhythm or conduction abnormalities requiring clinical intervention, such as ventricular arrhythmias, second- or third-degree atrioventricular block (participants may be eligible if the Investigator assesses no significant risks);\n    3. Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy);\n    4. Clinically significant history of QT interval prolongation, or QTcF (calculated via Fridericia's formula) \\> 480 ms at screening, or left ventricular ejection fraction \\\u003C 50%;\n    5. Arterial or venous thromboembolic events within 6 months prior to the first study drug administration, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, pulmonary embolism, etc. Participants with stable thrombosis may be enrolled if the Investigator determines no cardiovascular risks.\n    6. Uncontrolled hypertension (systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\> 100 mmHg).\n18. Active or recurrent autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for the following conditions:\n\n    1. Autoimmune thyroid disease with clinically stable status;\n    2. Type 1 diabetes managed with hormone replacement therapy;\n    3. Autoimmune skin disorders well controlled with topical therapy (e.g., low-potency topical corticosteroids) without acute exacerbations requiring additional treatment within 12 months before screening (e.g., eczema, psoriasis, lichen simplex chronicus, or vitiligo involving \\\u003C10% of total body surface area).\n19. Prior immunotherapy complicated with Grade ≥3 immune-related adverse events (irAEs) or Grade ≥2 immune-related myocarditis (excluding stabilized immune-related endocrine abnormalities).\n20. Known hypersensitivity to any component of the study treatment; history of hypersensitivity to premedications; or poorly controlled asthma (presentation of three or more asthma symptoms with partially controlled or uncontrolled status).\n21. Female participants who are pregnant or breastfeeding.\n22. History of other malignant tumors within 2 years prior to the first dose, or concurrent active malignant tumors (participants with cured localized tumors may be enrolled, including basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the prostate, cervical carcinoma in situ, breast carcinoma in situ, etc.).\n23. Known alcohol or drug dependence; or other severe systemic medical conditions deemed by the Investigator to render the participant unsuitable for participation in this clinical study for any other reason.",{"count":50,"type":22},288,[25,52],"PHASE2","This is an open-label, multicenter Phase Ib\u002FII clinical study designed to evaluate the safety, tolerability, and efficacy of combination therapy with SYS6090 Injection in participants with hepatocellular carcinoma (HCC).",[55],"HCC - Hepatocellular Carcinoma","2026-08-07",{"date":58,"type":33},"2026-08-12",{"date":35,"type":22},{"date":61,"type":22},"2031-09-30",{"name":39,"class":40},{"id":64,"slug":65,"hasResults":12,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":23,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":4},"100651234","phase-3-sys6010-vs-investigators-choice-of-monotherapy-in-patients-with-recurrent-or-metastatic-hnscc-100651234","NCT07758621","SYS6010 vs Investigator's Choice of Monotherapy in Patients With Recurrent or Metastatic HNSCC","A Randomized, Controlled, Open-Label, Multicenter Phase 3 Trial Evaluating the Efficacy and Safety of SYS6010 Versus Investigator's Choice of Monotherapy in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Participantss aged 18-75 years (inclusive);\n2. Patients with pathologically confirmed head and neck squamous cell carcinoma (HNSCC);.\n3. Participants have failed of platinum-based chemotherapy and PD-(L)1 inhibitors; for participants who received platinum-based chemotherapy and PD-(L)1 inhibitors in the adjuvant\u002Fneoadjuvant setting, disease recurrence or progression must have occurred within 6 months after completion of that therapy; radiographically confirmed disease progression during or after the most recent treatment regimen;\n4. Participants must have measurable disease according to RECIST (version 1.1);\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n6. Life expectancy of ≥ 3 months;\n7. Adequate major organ function (hematology, renal, liver, and coagulation) as determined by laboratory tests performed within 7 days prior to randomization;\n8. Sexually active fertile participants must agree to use methods of contraception during the study and at least 7 months after termination of study therapy and have a negative serum pregnancy test within 7 days prior to randomization;\n9. Willing to participate in the study, understand the study procedures, and sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Pathologically confirmed patients with adenocarcinoma or sarcomatoid carcinoma etc.;\n2. Active central nervous system metastases or leptomeningeal metastasis;\n3. History of another malignancy within 3 years prior to randomization\n4. Allergy to any component of SYS6010 or to humanized monoclonal antibodies，or to the control drugs (docetaxel, methotrexate, paclitaxel, cetuximab);\n5. Prior treatment with TOP1(including ADCs);\n6. Prior EGFR mAb therapy within 4 months prior to treatment;\n7. Adverse events from prior antitumor therapy not recovered to Grade ≤ 1 per NCI-CTCAE v6.0；\n8. Use of any of the medications or treatments within the specified washout period (prior to randomization )\n9. History of serious cardiovascular or cerebrovascular conditions within 6 months prior to randomization, including but not limited to: Severe arrhythmias (e.g., ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, QTcF \\> 470 ms) (Fridericia formula: QTcF = QT\u002FRR0.33, RR = 60\u002Fheart rate). Myocardial infarction, unstable angina, aortic dissection, angioplasty, or coronary artery bypass surgery. NYHA class II or higher heart failure with LVEF \\\u003C 50%.Stroke or other grade ≥ 3 cardiovascular\u002Fcerebrovascular events. pulmonary embolism;\n10. Imaging examination suggests tumor invasion of the cervical, thoracic, and abdominal great vessels; and the investigator assessed that there was no risk of bleeding.\n11. Patients who have a history of ILD\u002Fnon-infectious pneumonitis treated with corticosteroids in the past, currently have ILD\u002Fnon-infectious pneumonitis, for whom imaging examinations at screening cannot rule out ILD\u002Fnon-infectious pneumonitis,\n12. Severe infection within 4 weeks prior to randomization, such as bacteremia requiring hospitalization, severe pneumonia, or active pulmonary tuberculosis;active systemic infections requiring antibiotics within 2 weeks prior to randomization;\n13. Previous permanent discontinuation of EGFR-targeted therapy due to skin toxicity, or currently have skin diseases requiring oral or intravenous medication;\n14. History of ulcerative colitis or Crohn's disease;\n15. Pleural effusion or pericardial effusion requiring clinical intervention within 2 weeks prior to randomization;\n16. Active HBV or HCV infection (hepatitis B surface antigen and\u002For hepatitis B core antibody positive and HBV DNA copies ≥ 1×10\\^4 copies\u002FmL or ≥ 2000 IU\u002FmL, HCV antibody positive and HCV RNA above the lower limit of detection of the analytical procedure). Note: For HBsAg-positive patients, it is recommended to start antiviral therapy before randomization, nucleoside analogues are recommended, such as entecavir, tenofovir disoproxil;\n17. History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases), history of allogeneic stem cell or organ transplant;\n18. Other conditions that the investigator deems unsuitable for participation in this clinical study (such as mental disorders, macular cystoid oedema, severe corneal disorders, uncontrolled or poorly controlled hypertension and diabetes mellitus, impaired oxygenation requiring continuous oxygen supplementation, etc.).","75 Years",{"count":72,"type":22},340,[74],"PHASE3","This study is a randomized, controlled, open-label, multicenter phase III clinical trial, which aims to evaluate the efficacy, safety of SYS6010 compared with monotherapy in participants with HNSCC.",[77],"Head and Neck Squamous Cell Carcinoma","2026-08-06",{"date":80,"type":33},"2026-08-11",{"date":82,"type":22},"2026-08-15",{"date":84,"type":22},"2028-12-01",{"name":39,"class":40},{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":41},"100650574","phase-1-a-phase-ibii-study-of-sys6090-combination-therapy-in-advanced-colorectal-cancer-100650574","NCT07750041","A Phase Ib\u002FII Study of SYS6090 Combination Therapy in Advanced Colorectal Cancer","A Phase Ib\u002FII Study to Evaluate the Safety, Tolerability, and Efficacy of SYS6090 in Combination With Other Therapies in Participants With Advanced Coloretal Cancer","\\*Eligibility Criteria:\n\nInclusion Criteria:\n\n1. Subjects must be ≥18 years of age.\n2. Histologically or cytologically confirmed unresectable advanced or metastatic colorectal cancer with pMMR\u002FMSS status, assigned to corresponding cohorts as follows:\n\n   Cohort 1 (2L\u002F3L) of Phase Ib \\& Phase II: Subjects must have disease progression after no more than 2 lines of standard systemic therapy (prior regimens must contain fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy); tumor tissue confirmed as pMMR by IHC or MSS by NGS\u002FPCR; Cohort 2 (1L) of Phase Ib \\& Phase II: Subjects have received no prior systemic anti-tumor therapy for advanced disease; tumor tissue confirmed as pMMR by IHC or MSS by NGS\u002FPCR.\n3. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.\n4. Eastern Cooperative Oncology Group performance status of 0 or 1.\n5. Expected survival ≥ 3 months.\n6. Has protocol-defined adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Subjects with clinically active central nervous system metastases;\n2. with a history of other primary malignant tumors within 5 years before administration;\n3. Subjects assigned to Cohort 1 who have received prior regorafenib treatment.;\n4. Prior documented interstitial lung disease (ILD)\u002F pneumonitis that required steroids, current ILD\u002F pneumonitis, or suspected ILD\u002F pneumonitis that cannot be ruled out by imaging at screening;\n5. Uncontrolled or significant cardiovascular disease;\n6. Clinically uncontrolled pleural effusion, ascites or pericardial effusion;\n7. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to Grade ≤ 1 or baseline .",{"count":94,"type":22},260,[25,52],"This study constitutes an open-label, multi-cohort, multi-center Phase Ib\u002FII clinical study, developed to assess the safety, tolerability, and therapeutic efficacy of SYS6090 injection when administered in combination with bevacizumab, or in triple combination with bevacizumab and chemotherapy, among patients diagnosed with advanced colorectal cancer.",[98],"Unresectable Advanced or Metastatic Colorectal Cancer","2026-08-02",{"date":78,"type":33},{"date":102,"type":22},"2026-08-30",{"date":104,"type":22},"2029-08-30",{"name":39,"class":40},{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":41},"100650260","phase-1-a-phase-iiia-study-of-sys6041-in-patients-with-advanced-solid-tumors-100650260","NCT07744763","A Phase I\u002FIIa Study of SYS6041 in Patients With Advanced Solid Tumors","A Multicenter, Open-label, Dose-escalation and Dose-expansion Phase I\u002FIIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Antitumor Activity of SYS6041 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Aged \\>= 18 years.\n2. The expected survival time is \\>=3 months.\n3. Eastern Cooperative Oncology Group (ECOG) 0\\~1.\n4. Willing to provide recent tumor tissue specimens for FRα testing.\n5. At least one measurable lesion as defined by RECIST Version 1.1.\n6. The organ function level and related laboratory indicators must meet requirement.\n7. Additional inclusion criteria for the dose-escalation stage: Histologically or cytologically confirmed unresectable locally advanced or metastatic ovarian cancer, endometrial cancer, NSCLC, or breast cancer with disease progression following standard therapy.\n8. Additional inclusion criteria for the expansion cohort stage: Radiological and\u002For pathological progression or intolerance to the most recent systemic anti-tumor therapy.\n9. Additional inclusion criteria for the expansion cohort stage: Histologically or cytologically confirmed advanced solid tumors, including ovarian cancer, endometrial cancer, or other FRα-positive solid tumors that have received at least one prior line of systemic therapy.\n10. Agree to use reliable and effective methods of contraception during the study treatment period and for at least 5 months (for male subjects) or 8 months (for female subjects) after the last study treatment.\n\nExclusion Criteria:\n\n1. Known severe allergic reaction to the study drug or any other components\u002Fexcipients in the formulation.\n2. Untreated (including those identified at baseline screening) or unstable parenchymal brain metastases, spinal metastases or spinal cord compression, carcinomatous meningitis.\n3. History of other malignant tumors within 3 years, or concurrent active malignant tumors.\n4. Prior treatment with ADCs carrying topoisomerase I inhibitor payloads.\n5. Adverse reactions from prior anti-tumor therapies have not recovered to Grade ≤1 per CTCAE v5.0.\n6. Received immunotherapy, macromolecular targeted therapy or other anti-tumor biotherapy within 4 weeks prior to the first dose; or received endocrine therapy, cytotoxic chemotherapy, small-molecule targeted therapy within 2 weeks prior to the first dose; or received traditional Chinese medicinal preparations with anti-tumor indications within 2 weeks prior to the first dose.\n7. Patients who have undergone major organ surgery within 28 days prior to the first dose, or have planned systemic or local tumor resection during the study period.\n8. Patients who have received strong CYP3A4 inhibitors or strong CYP3A4 inducers systemically within 14 days prior to the first dose, or require continuous systemic administration of such agents during study treatment.\n9. Severe chronic or active infections requiring intravenous antibacterial, antifungal or antiviral therapy within 14 days prior to the first dose (including tuberculous infection, etc.).\n10. Subjects receiving long-term immunosuppressive therapy (e.g., cyclosporine) or daily systemic steroid therapy.\n11. Uncontrolled serous cavity effusions requiring frequent drainage or medical intervention within 7 days prior to the first dose.\n12. Presence of risk factors for intestinal obstruction or intestinal perforation.\n13. Grade ≥2 severe diarrhea per CTCAE within 7 days prior to the first dose.\n14. History of non-infectious lung disease\u002Fpneumonitis requiring steroid therapy, or current interstitial lung disease\u002Fpneumonitis, or suspected such diseases identified by imaging examinations during screening.\n15. History of severe cardiovascular diseases.\n16. Female subjects who are pregnant or breastfeeding.\n17. Any other circumstances that may interfere with the subject's participation in study procedures, compromise the subject's maximum benefit from study participation, or affect study results, in the Investigator's judgment.",{"count":94,"type":22},[25,52],"This trial is the first-in-human study of SYS6041, a multicenter, open-label, dose-escalation, dose-reassignment and cohort-expansion Phase I\u002FIIa clinical study, which aims to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary antitumor efficacy of SYS6041 in participants with advanced solid tumors.",[117],"Advanced Solid Tumors","RECRUITING",{"date":120,"type":33},"2026-08-04",{"date":122,"type":33},"2025-03-28",{"date":124,"type":22},"2027-03-31",{"name":39,"class":40},{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":23,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":4},"100647928","phase-2-a-clinical-study-of-sys6041-combination-therapy-for-recurrent-ovarian-cancer-100647928","NCT07714668","A Clinical Study of SYS6041 Combination Therapy for Recurrent Ovarian Cancer","An Open-label , Multicenter, Multicohort, Phase II Clinical Study Evaluating the Efficacy and Safety of SYS6041 Combination Therapy for Recurrent Ovarian Cancer","Inclusion Criteria:\n\n1. Fully understand this clinical trial and voluntarily sign the written informed consent form\n2. Age ≥ 18 years old\n3. Histologically or cytologically confirmed high-grade serous ovarian, epithelial fallopian tube carcinoma, and primary peritoneal cancer\n4. Cohort A and B：subjects with platinum-sensitive disease who have received ≤2 prior lines of systemic chemotherapy and if have a BRCAm or HRD-positive status must have recieved PARP inhibitor maintenance therapy; Cohort C: subjects with platinum-resistant disease who have received ≤3 prior lines of systemic chemotherapy\n5. Disease progression or intolerability with the most recent systemic anti-tumor treatment\n6. Adequate organ function with laboratory tests meeting criteria\n7. Have measurable disease per RECIST v1.1\n8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n9. Expected survival ≥ 3 months\n10. Subjects of reproductive potential (males and females) must agree to use reliable contraceptive methods with their partner(s) throughout the trial period and for a minimum of 8 months following the last study drug administration\n\nExclusion Criteria:\n\n1. Prior treatment with any topoisomerase I inhibitor-loaded ADC therapy\n2. History of other malignancies within 3 years before randomization\u002Ffirst dose or concurrent active malignancies (except cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc., which are allowed to enroll)\n3. Subjects with active central nervous system (CNS) manifestations during the screening period, CNS metastases requiring corticosteroid therapy within 28 days prior to the first study drug administration, lesions involving the brainstem, or carcinomatous meningitis.\n4. Adverse reactions from prior anti-tumor therapy have not recovered to CTCAE 6.0 grade ≤ 1 (except for toxicities such as alopecia that researchers judge to have no safety risk)\n5. Major surgery within 28 days before randomization\u002Ffirst dose, or planned to undergo systemic or local tumor resection during the study period\n6. Subjects requiring folic acid supplementation during the screening period\n7. Subjects who have received strong CYP3A4 inhibitors or strong CYP3A4 inducers within 14 days prior to randomization\u002Ffirst study drug administration, or who require continuous systemic administration of such agents during the study treatment period\n8. History of severe gastrointestinal disease\n9. History of severe cardiovascular disease\n10. Uncontrolled serous effusions (e.g., pleural effusion, ascites, pericardial effusion) that necessitate frequent drainage or medical intervention within 14 days before randomization\u002Ffirst dose, or requirement for further intervention within 2 weeks after a previous intervention\n11. Subjects with a history of interstitial lung disease (ILD) or non-infectious pneumonia, current non-infectious pneumonia requiring corticosteroid treatment, or suspected ILD\u002Fnon-infectious pneumonia identified at screening\n12. Active bacterial, fungal or viral infection within 14 days before randomization\u002Ffirst dose (defined as requiring intravenous anti-bacterial, anti-fungal or anti-viral drug therapy)\n13. Active hepatitis B or hepatitis C, defined as HBsAg positive and HBV DNA \\> 2000 IU\u002FmL for active hepatitis B; defined as HCV-Ab positive and HCV RNA \\> ULN for active hepatitis C\n14. History of immunodeficiency or positive HIV antibody test during screening\n15. Presence of other conditions that may interfere with participants' participation in study procedures, not in line with participants' maximum benefit from participating in the study, or affect study results: such as history of mental illness, drug abuse or substance abuse, any other clinically significant disease or condition, etc.",{"count":134,"type":22},171,[52],"This is an open-label, multicenter Phase II clinical study conducted in subjects with recurrent ovarian cancer.",[138,139],"Ovarian Cancer","Recurrent Ovarian Cancer","2026-07-14",{"date":142,"type":33},"2026-07-20",{"date":144,"type":22},"2026-08-31",{"date":146,"type":22},"2029-08-31",{"name":39,"class":40},{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":12,"sex":155,"minAge":18,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":4},"100647284","phase-3-a-study-of-sys6043-in-platinum-resistant-advanced-ovarian-primary-peritoneal-or-fallopian-tube-cancers-100647284","NCT07708753","A Study of SYS6043 in Platinum-Resistant, Advanced Ovarian, Primary Peritoneal, or Fallopian Tube Cancers","A Randomized, Multicenter, Open-label, Phase 3 Clinical Trial Evaluating SYS6043 Versus Investigator's Choice Chemotherapy in Participants With Platinum-resistant Advanced Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer.","Inclusion Criteria:\n\n1. Female participants aged ≥ 18 years (as of the date of signed informed consent).\n2. Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a histologic subtype of high-grade serous carcinoma or G2-G3 endometrioid carcinoma.\n3. Participants with prior platinum-based therapy and confirmed platinum-resistant recurrent disease, defined as disease progression or recurrence during platinum-based chemotherapy or within 6 months (183 days) after the last dose of platinum-based chemotherapy. No more than 1 line of systemic therapy following platinum-resistant recurrence, and a total number of treatment lines not exceeding 4 lines.\n4. At least one evaluable extracranial lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n5. Expected survival of the participant is ≥ 3 months.\n6. ECOG performance status 0-1, with no deterioration in ECOG score within 28 days prior to enrollment.\n7. LVEF ≥ 50% as demonstrated by ECHO or MUGA obtained within 28 days before enrollment.\n8. Major organ function must meet the following criteria within 7 days prior to enrollment:\n\n   1. Complete blood count (no whole blood, red blood cell, or platelet transfusion, and no administration of hematopoietic growth factors \\[G-CSF or GM-CSF\\], erythropoietin \\[EPO\\], or thrombopoietin \\[TPO\\] to correct blood cell counts within 7 days before sampling):i. Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL;Platelet count (PLT) ≥ 100 × 10\\^9\u002FL;Hemoglobin (HGB) ≥ 90 g\u002FL.\n   2. Blood biochemistry:i. Serum creatinine ≤ 1.5 × ULN;Serum total bilirubin (TBIL) ≤ 1.5 × ULN (participants with Gilbert's syndrome may be allowed up to 3 × ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5.0 × ULN for participants with hepatocellular carcinoma or liver metastasis);Serum albumin ≥ 30 g\u002FL.\n\n      3\\) Coagulation function: i. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN (for participants not receiving anticoagulation therapy; for those on anticoagulation therapy, levels must be within the therapeutic range with stable dose).\n\n10\\. Any toxicities related to prior therapy have resolved to CTCAE version 6.0 grade ≤1 or baseline level, excluding alopecia, fatigue, pigmentation, hypothyroidism stabilized with hormone replacement therapy, grade 2 peripheral neuropathy following chemotherapy, and other toxicities that the investigator deems not to pose a safety risk to participants.\n\n11\\. A sufficient washout period from prior anti-tumor therapy is required prior to the first study drug administration.\n\n12\\. Willing to provide a previously excised tumor sample or undergo a fresh tumor biopsy for the assessment of B7-H3 expression level (if no contraindications exist).\n\n13\\. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization.Female participants of childbearing potential must agree to use highly effective contraception during the study and for at least 7 months after the last dose of study drug.Females must not be breastfeeding during this period.Females must not donate oocytes or undergo oocyte retrieval for personal use during this period.\n\n14\\. Provides voluntary written informed consent after adequate understanding of the clinical trial.\n\nExclusion Criteria:\n\n1. Patients with platinum-refractory disease (progression within 1 month after the last platinum-containing therapy).\n2. Prior treatment with B7H3-targeted therapy.\n3. Prior treatment with irinotecan, topotecan, any other topoisomerase I inhibitor (including investigational TOP1 inhibitors), or topoisomerase inhibitor-antibody drug conjugate (e.g., trastuzumab deruxtecan, etc.).\n4. Patients for whom paclitaxel, topotecan, and pegylated liposomal doxorubicin (as listed in the control group) are all considered inappropriate by the investigator.\n5. History of severe cardiac or cerebrovascular disease, including but not limited to: heart failure ≥ New York Heart Association (NYHA) Class 2; acute coronary syndrome (e.g., myocardial infarction, unstable angina, etc.) within 6 months prior to screening; acute cerebrovascular disease (e.g., transient ischemic attack, cerebral infarction, cerebral hemorrhage, etc.) within 6 months prior to screening.\n6. Mean corrected QT interval using the Fridericia formula (QTcF) \\> 470 milliseconds (ms) based on the results of three 12-lead electrocardiogram (ECG) examinations; history of serious cardiac arrhythmia (e.g., complete left bundle branch block, third-degree atrioventricular block, atrial fibrillation, atrial flutter, ventricular fibrillation, ventricular flutter, etc.), excluding transient atrial fibrillation and atrial flutter.\n7. Unable or unwilling to discontinue concomitant medications known to prolong the QT interval.\n8. A history of or current interstitial lung disease (ILD) requiring glucocorticoid treatment, non-infectious interstitial pneumonia, pulmonary fibrosis, and radiation pneumonitis requiring hormone treatment, or suspected of having such diseases by imaging examination at the time of screening.\n9. A history of underlying lung diseases, including but not limited to pulmonary embolism within 3 months prior to the start of study treatment, severe asthma, severe COPD, restrictive lung disease, and other clinically significant lung damage or requiring supplementary oxygen.\n10. Patients with active pulmonary tuberculosis (those who have received adequate treatment and stopped anti-tuberculosis treatment for ≥ 3 months before randomization may be enrolled).\n11. Any autoimmune disease, connective tissue disease, or inflammatory disease involving the lungs that is recorded or suspected at the time of screening (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.).\n12. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening, such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism (patients with stable lower extremity deep vein thrombosis, intermuscular venous thrombosis, or infusion-related thrombosis that are judged to be risk-free by the investigator may be included).\n13. Presence of uncontrolled infection requiring intravenous antibiotics, antiviral drugs, or antifungal drugs.\n14. Known human immunodeficiency virus (HIV) infection, or current active syphilis infection (i.e., positive treponema pallidum antibody (RPR or TRUST) or requiring systemic treatment).\n15. Participants with active viral hepatitis (positive hepatitis B surface antigen and\u002For positive hepatitis B core antibody with HBV DNA ≥ 10000 copies\u002Fml or 2000 IU\u002Fml; positive hepatitis C virus (HCV) with HCV RNA above the lower limit of detection by the analytical method).\n16. Presence of spinal cord compression or clinically active brain metastasis or meningeal metastasis. Participants with central nervous system metastases who have received prior central nervous system-directed therapy and have been radiologically and neurologically stable within 4 weeks before the first dose \\[i.e., imaging shows no new or enlarged metastatic lesions, no need for corticosteroid treatment or taking a stable or decreasing dose of corticosteroids (equivalent to ≤ 10 mg\u002Fday prednisone), and no symptoms\\] are eligible to enter the study. Untreated central nervous system metastases may be enrolled if the following conditions are met: no neurological symptoms, no need for surgery, radiotherapy, or corticosteroid treatment, and no obvious edema around the brain metastases.\n17. Diagnosis of active malignant tumor within 3 years prior to randomization, except for the following cases: cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, and\u002For carcinoma in situ that has undergone radical resection, which the investigator deems eligible for enrollment.\n18. Moderate or above pleural effusion, pericardial effusion, or ascites; if effusion drainage is performed (except for diagnostic thoracentesis), participants who have been stable for at least 2 weeks after drainage may be enrolled.\n19. Presence of fistula diseases and perforation diseases such as genital fistula, genitourinary fistula, and enterovaginal fistula (if the perforation or fistula has been treated by resection or repair and the disease has recovered, enrollment is allowed).\n20. Presence of intestinal obstruction, or signs and symptoms of intestinal obstruction, or requiring parenteral nutrition within 1 month prior to the start of study treatment; however, screening may be performed if surgical treatment has been performed and the obstruction is completely relieved; prior intestinal stent implantation with the intestinal stent still not removed by the screening period; gastrointestinal bleeding (including melena, hematochezia, etc.) within 1 month prior to randomization (those confirmed to have hemorrhoidal bleeding or only positive fecal occult blood may be enrolled); presence of abdominal abscess within 1 month prior to randomization.\n21. Subjects who have received systemic administration of strong inhibitors or strong inducers of CYP3A4 and CYP2C8, or inhibitors of OATP1B1\u002FOATP1B3 within 14 days prior to the first dose of study drug, or those who require continuous systemic use of such medicinal products during the study period.\n22. Known allergy to the active ingredient or excipients of the study drug.\n23. Having undergone autologous or allogeneic stem cell transplantation.\n24. Subjects with a history of severe neurological or psychiatric disorders, including but not limited to dementia, depressive disorder, epileptic seizure, and bipolar disorder.\n25. Have a history of drug abuse, or have any other medical conditions that, in the opinion of the Investigator, may increase the safety risk to the participant, or interfere with the participant's enrollment in and completion of the clinical study, or confound the evaluation of the study results.\n26. Subjects planning to receive live vaccines or vaccinated with live vaccines within 28 days before the first dose of study drug.\n27. Subjects with other severe physical conditions, clinically significant laboratory abnormalities, or poor treatment compliance, who may increase the risks of study participation, interfere with study outcomes, or are otherwise considered unsuitable for enrollment in this study by the Investigator.","FEMALE",{"count":157,"type":22},460,[74],"This is a randomized, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of SYS6043 versus investigator's choice chemotherapy in participants with platinum-resistant ovarian cancer, primary peritoneal, or fallopian tube cancer.",[161,162,163],"Platinum-resistant Ovarian Cancer","Platinum-resistant Primary Peritoneal Cancer","Platinum-resistant Fallopian Tube Cancer","2026-07-13",{"date":166,"type":33},"2026-07-16",{"date":168,"type":22},"2026-07-01",{"date":170,"type":22},"2030-12-01",{"name":39,"class":40},{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":155,"minAge":18,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":23,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":41},"100645596","phase-2-a-phase-ii-clinical-trial-evaluating-the-efficacy-and-safety-of-sys6026-injection-in-participants-with-hpv16-or-18-related-high-grade-cervical-squamous-intraepithelial-lesions-100645596","NCT07702656","A Phase II Clinical Trial Evaluating the Efficacy and Safety of SYS6026 Injection in Participants With HPV16 or 18-related High-grade Cervical Squamous Intraepithelial Lesions","Inclusion Criteria:\n\n* Age must be 18 years old or above;\n* During the screening period, the research center confirmed participants with HPV type 16 and\u002For type 18 cervical infection;\n* During screening, the research center confirmed histological evidence of cervical HSIL (CIN grade 2\\~CIN3) (lesions may be obtained within 3 months prior to the first study treatment);\n* Colposcopy results at each research center during the screening period must meet the following conditions: 1) Fully visible squamous-columnar epithelial junction (type I or type II transformation zone), with fully visible upper white acetic acid epithelial or suspected CIN lesions; 2) Cervical lesions can be touched and sampled by biopsy instruments, and the cervical lesions are sufficiently large to ensure visible lesions remain for observation during the study period;\n* Consent was given to undergo lesion biopsy during the screening period and to perform surgical resection or biopsy at 36 weeks after the first vaccination;\n* During the screening period, sufficient lesion tissue biopsy samples and cervical swab samples can be obtained for CIN and HPV testing in the central laboratory;\n* Major organ function was normal within one week prior to the first vaccination:\n\n  1. Blood count: Hb≥100 g\u002FL; PLT≥100×109\u002FL； Neutrophil count≥ 1.5×109\u002FL;\n  2. Liver: TB≤ 1.5× ULN; ALT and AST ≤ 2.5× ULN; Plasma albumin ≥30 g\u002FL;\n  3. Kidney: Scr ≤ 1.5× ULN, or creatinine clearance ≥60 mL\u002Fmin (calculated by Cockcroft-Gault formula);\n  4. Coagulation function: PT, APTT, and INR ≤1.5× ULN;\n* The investigator determined that the ECG during the screening period was normal or without clinically significant results; 9) Normal vital sign test results:\n\n  1. On the day of the first vaccination, the axillary temperature ≤ 37.0°C;\n  2. Systolic pressure \\\u003C 140 mmHg and diastolic pressure \\\u003C 90 mmHg;\n* Eligible participants with fertility must agree to use reliable contraceptive methods (hormonal contraceptives, barrier therapy, or abstinence) with their partner during the trial and for at least one year after the last dose; Female participants of childbearing age must have a negative blood pregnancy test within 7 days prior to enrollment;\n* Fully understand this clinical trial and voluntarily sign a written informed consent form\n\nExclusion Criteria:\n\n* Screening combined with other high-risk HPV subtypes (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68);\n* Cases with VIN\u002FVAIN\u002FAIN or AIS or other lesions should be excluded.\n* During screening, cytological or histopathological examination yields any of the following: AIS, AGC-FN, invasive cancer, etc.;\n* HSIL treatment within 4 weeks prior to the first vaccination;\n* Previous receipt of therapeutic HPV vaccines (approved preventive HPV vaccines are permitted);\n* Received any live vaccine injection within 4 weeks prior to the first vaccination or received any live vaccine injection within 2 weeks;\n* Previous or current history of other malignant tumors (except for the following tumors: ductal carcinoma in situ that has been fully treated and completely cured, basal cell carcinoma of the skin, superficial bladder tumors, or any malignant tumor cured more than 2 years prior to study entry);\n* Having active autoimmune disease or a history of autoimmune disease;\n* Other immune dysfunction conditions, such as receiving immunosuppressive or immunosuppressive therapy within 3 months (continuous oral or infusion for more than 14 days); or those who have received whole blood, plasma, or immunoglobulin therapy within the past month; Or those with known immunological impairment or impairment diagnosed by hospitals, or any condition leading to functional splenectomy or splenectomy;\n* A history of severe allergy to any vaccine or known components of SYS6026 injections;\n* Participated in other clinical trials within 4 weeks prior to the first use of the investigational vaccine;\n* Surgical procedure or significant trauma within 4 weeks prior to the first use of the investigational vaccine;\n* Fever (axillary temperature ≥ 38.0°C) within 3 days before first use of the trial vaccine, acute illness or acute exacerbation of chronic disease within the first 5 days, or fever-reducer, analgesic, or anti-allergy medication taken within 3 days before the first trial vaccine dose; Hepatitis C virus infection;\n* Active hepatitis B (hepatitis B virus titer\\> 1000 copies\u002FmL or 200 IU\u002FmL), allowing prophylactic antiviral therapy other than interferon;\n* History of immunodeficiency, or positive HIV antibody test;\n* Accompanied by systemic active bacterial, fungal, or viral infections (defined as requiring intravenous antibacterial, antifungal, or antiviral drug treatment);\n* Long-term (≥7-day) systemic use of glucocorticoids (prednisone ≥20 mg\u002Fday or equivalent dose) or other immunosuppressive treatments (short-term glucocorticoids are allowed for preventive treatment; Topical use of glucocorticoids is permitted, such as ocular, intra-articulary, intranasal, and inhaled types. Current or planned use of antirheumatic or immunomodulatory drugs, such as azathioprine, cyclophosphamide, cyclosporine, methotrexate, and TNFα inhibitors (such as infliximab, adalimumab, or etanercept), etc.;\n* History of solid organ transplantation or bone marrow transplantation;\n* Pregnant or breastfeeding women;\n* Other circumstances that may interfere with participant participation in study procedures or may not align with the maximum benefit or impact on study outcomes: such as a history of mental illness, drug use, or drug abuse, any other clinically significant diseases or conditions, such as medically unstable diseases (e.g., chronic kidney failure; Angina, myocardial ischemia or infarction, grade 3 or higher congestive heart failure, cardiomyopathy, or clinically significant arrhythmias), etc.",{"count":179,"type":22},175,[52],"This trial is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study designed to evaluate the efficacy and safety of SYS6026 at different doses compared to placebo in treating patients with HPV16 or 18-related high-grade cervical squamous intraepithelial lesions (HSIL).",[183],"High-grade Cervical Intraepithelial Lesions","2026-07-09",{"date":140,"type":33},{"date":187,"type":22},"2026-07-10",{"date":189,"type":22},"2028-12-30",{"name":39,"class":40},{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":199,"phases":4,"briefSummary":200,"conditions":201,"keywords":203,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":209,"leadSponsor":211,"locationsCount":4},"100646859","a-multicenter-open-label-phase-ii-clinical-study-to-evaluate-the-safety-tolerability-efficacy-pharmacokinetics-pk-and-immunogenicity-of-the-combination-therapy-of-sys6026-in-the-treatment-of-advanced-solid-tumors-100646859","NCT07684261","A Multicenter, Open-label, Phase II Clinical Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics (PK), and Immunogenicity of the Combination Therapy of SYS6026 in the Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Confirmation by the research center of HPV type 16 and\u002For 18 infection in tumor tissue;\n3. Pathologically confirmed unresectable locally advanced or metastatic solid tumor;\n4. ECOG PS score of 0-1;\n5. Estimated survival of at least 3 months;\n6. Normal function of major organs within 1 week prior to the initial vaccination\u002Frandomization (no administration of erythrocyte transfusion or hematopoietic stimulation factors \\[e.g., granulocyte colony-stimulating factor, erythropoietin, thrombopoietin\\] within 14 days before screening, and no platelet transfusion within 7 days before screening):\n\n   1. ANC≥1.5×109\u002FL；\n   2. PLT≥100×109\u002FL；\n   3. Hb≥90 g\u002FL；\n   4. TBIL≤1.5×ULN，Participants with Gilbert syndrome\n   5. TBIL≤3×ULN；\n   6. ALT和AST≤2.5×ULN；\n   7. Cr≤1.5×ULN，or creatinine clearance≥45 mL\u002Fmin（Cockcroft-Gault）；\n   8. APTT≤1.5×ULN，PT≤1.5×ULN，INR≤1.5×ULN。\n7. Eligible participants of reproductive age (both males and females) must agree to use reliable contraceptive methods (hormonal contraceptives, barrier methods, or abstinence) with their partner from the date of signing the informed consent form until 6 months after the last dose administration.\n\n   Applicable only during the combination dose exploration phase:\n8. patients in advanced stages who have failed standard treatment (including disease progression or intolerance to standard therapy) and lack effective therapeutic options; where intolerance to standard therapy refers to permanent discontinuation of previous standard treatment requiring switching to alternative regimens; and meeting RECIST 1.1 criteria with at least one evaluable lesion.\n9. According to RECIST 1.1, there must be at least one evaluable lesion;\n\n   Applicable only to the queue expansion phase:\n10. Enrollment during the queue expansion phase:\n\n    1. Cluster 1: Advanced recurrent or metastatic cervical cancer that has failed at least one line of standard therapy;\n    2. Cluster 2: Irresectable locally advanced or metastatic solid tumors (including anal, vulvar, vaginal, oropharyngeal, oral, laryngeal, and penile cancers) that have failed first-line standard therapy;\n    3. Cluster 3 (randomized controlled cohort for first-line maintenance therapy in cervical cancer): PD-L1-positive advanced recurrent or metastatic cervical cancer patients who received platinum-based chemotherapy plus encetuximab\u002FPD-(L)1 inhibitor ± bevacizumab for ≤6 cycles without progression, with the last antitumor treatment administered no later than 6 weeks prior to randomization.\n11. Adequate tumor specimens can be provided for biomarker testing;\n12. according to RECIST 1.1, there must be at least one measurable lesion (cohorts 1 and 2).\n\nExclusion Criteria:\n\n1. Tumor tissue testing reveals co-infection with other high-risk HPV types;\n2. Presence of two primary tumors (applicable only to Cohort 3); for patients not in Cohort 3, inclusion is permitted if they have two primary cancers that are unsuitable for surgery, have failed standard treatment, and are considered by investigators to benefit from this study;\n3. Adverse reactions from prior antitumor therapy have not yet resolved to CTCAE Grade V5.0 level ≤1 (excluding alopecia or participants deemed clinically insignificant by investigators);\n4. Participation in other clinical trials involving the study drug within 28 days prior to first administration\u002Frandomization, excluding observational (non-interventional) trials or follow-up phases of intervention trials;\n5. Previous long-term (≥7 days) systemic use of immunosuppressants or initial systemic immunosuppressive therapy within 14 days prior to first administration\u002Frandomization;\n6. Patients who have received whole blood, plasma, or immunoglobulin therapy within the past 1 month; those with clinically diagnosed known immunological dysfunction or impairment; or individuals with functional splenectomy or complete splenectomy due to any medical condition..\n7. First administration of the vaccine\u002Fwithin 28 days prior to randomization, or planned administration of an attenuated live vaccine during the study period.\n8. During the screening period, patients exhibited systemic active infections (defined as requiring intravenous administration of antibacterial, antifungal, or antiviral medications)..\n9. Has a severe history of cardiovascular and cerebrovascular diseases, including but not limited to:\n\n   1. .Heart failure classified as grade ≥2 according to the NYHA classification;\n   2. first-time medication use or occurrence of myocardial infarction, treatment-needed arrhythmia, or unstable angina within 6 months prior to randomization;\n   3. first-time medication use or occurrence of arterial\u002Fvenous thrombosis or embolism (e.g., transient ischemic attack, cerebral hemorrhage, cerebral infarction \\[including lacunar infarction\\], deep vein thrombosis, or pulmonary embolism) within 6 months prior to randomization;\n   4. QTcF\\> 450 ms;\n   5. poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg during screening), with a history of hypertensive crisis or hypertensive encephalopathy.\n10. Patients with active autoimmune diseases or a history of autoimmune disorders (e.g., myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, pituititis, uveitis, etc.) are eligible. Eligible conditions include well-controlled type 1 diabetes mellitus; hypothyroidism requiring only hormone replacement therapy and well-controlled; skin diseases (e.g., vitiligo, psoriasis, alopecia) not requiring systemic treatment; or participants with a predicted low risk of disease recurrence in the absence of external triggers..\n11. Active hepatitis B (HBsAg-positive with HBV DNA ≥ 500 IU\u002FmL or ≥ 2,500 copies\u002FmL) or hepatitis C (HCV antibody-positive with HCV-RNA quantification ≥ the lower limit of the detection range) (Note: For HBsAg-positive patients, antiviral therapy is recommended prior to initial use of the study drug; nucleoside analogs such as entecavir or tenofovir disoproxil are preferred); co-infection with both HBV and HCV (HBsAg-positive and HCV antibody-positive) is not eligible for enrollment..\n12. History of immunodeficiency or positive HIV antibody test;\n13. Fever (axillary temperature ≥38.0°C) within 3 days prior to the first dose of the trial vaccine, acute illness within the previous 5 days, or acute exacerbation of a chronic condition; or use of antipyretics, analgesics, or anti-allergic medications within 3 days before the first vaccine dose;\n14. Interstitial lung disease with accompanying symptoms\u002Fsigns during screening (excluding radiation-induced localized interstitial pneumonia), non-infectious pneumonia requiring glucocorticoid therapy; history of specific pulmonary fibrosis, drug-induced pneumonia, specific pneumonia, or organized pneumonia (e.g., obstructive bronchiolitis, cryptogenic organized pneumonia);\n15. Pregnant or breastfeeding women;\n16. Known or suspected allergy to the trial drug or its components, severe allergy history, history of allergic diseases, or allergic predisposition;\n17. Other circumstances that may interfere with participant compliance with the study protocol, compromise maximum benefit from participation, or affect study outcomes.",{"count":198,"type":22},186,"OBSERVATIONAL","This trial is a multicenter, open-label, dose exploration and cohort expansion Phase II clinical study designed to evaluate the safety, immunogenicity, and preliminary efficacy of different dosing regimens of SYS6026 injection (hereinafter referred to as \"SYS6026\") combined with Enlonstobart in patients with unresectable locally advanced or metastatic solid tumors associated with HPV types 16 or 18. The study consists of two phases: dose exploration and cohort expansion.",[202],"Solid Tumor",[204],"solid tumors","2026-06-29",{"date":207,"type":33},"2026-07-06",{"date":142,"type":22},{"date":210,"type":22},"2029-12-31",{"name":39,"class":40},{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":70,"enrollmentInfo":219,"targetDuration":4,"studyType":23,"phases":221,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":225,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":229,"locationsCount":41},"100587407","phase-3-phase-iii-trial-of-sys6010-versus-platinum-based-chemotherapy-for-egfr-mutated-nsclcsynstar01-100587407","NCT06927986","Phase III Trial of SYS6010 Versus Platinum-based Chemotherapy for EGFR-mutated NSCLC（SYNSTAR01）","A Randomized, Open-label, Multi-center, Phase III Clinical Study Comparing SYS6010 With Platinum-based Chemotherapy in the Treatment of EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of EGFR TKI Treatment","Inclusion Criteria:\n\n1. Aged 18-75 (inclusive) years old, male or females;\n2. Patients with pathologically confirmed locally advanced or metastatic NSCLC, including those with stage IIIB or IIIC based on 8th edition of the AJCC staging system who are not suitable for surgical resection or radical chemoradiotherapy, or those with stage IV NSCLC. Patients with EGFR-mutated locally advanced or metastatic NSCLC who have failed EGFR TKI therapy，whereas patients progressed on first- or second-generation EGFR-TKIs must have also progressed on third-generation EGFR-TKIs if T790M mutation was detected as postive status.\n3. Presence of at least one EGFR-sensitive mutation;\n4. At least one measurable lesion confirmed by CT or MRI scan according to RECIST v1.1 criteria;\n5. ECOG performance status of 0-1;\n6. Life expectancy ≥ 3 months;\n7. Major organ function must meet the following criteria within 7 days prior to randomizationn (No component transfusion, G-CSF, TPO, IL-11, or EPO within 2 weeks prior to randomization):\n\n   Hematology： Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL; Platelet count (PLT) ≥100×10\\^9\u002FL; Hemoglobin (HGB) ≥100g\u002FL. Renal function Cr：≤ 1.5 × upper limit of normal (ULN) and creatinine clearance ≥ 50 mL\u002Fmin; Liver function Serum total bilirubin (TBIL) ：≤ 1.5 × ULN, ≤ 3 × ULN for patients with Gilbert syndrome\u002Fmetastases to liver Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)：≤ 2.5 × ULN, ≤ 5 × ULN for patients with metastases to liver Coagulation function Coagulation function Activated partial thromboplastin time (APTT) and international normalised ratio (INR)： ≤1.5×ULN\n8. Women of childbearing potential must have a negative blood pregnancy test within 7 days prior to randomization. Participants must agree to use effective contraception from the time of signing the informed consent form until 7 months after the last dose; during this period, women should not be breastfeeding, and men should avoid donating sperm;\n9. Voluntarily participate in this clinical study, understand the study procedures, and be able to sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed combined small cell lung cancer,squamous cell carcinoma, neuroendocrine carcinoma,or carcinosarcoma\n2. Patients with meningeal metastasis, brainstem metastasis, spinal cord metastasis and\u002For compression, or active CNS metastasis. Patients with supratentorial and\u002For cerebellar metastasis (i.e., without mesencephalon, pons, or medulla involvement) who have received local treatment, have achieved stability for at least 2 weeks prior to randomization (imaging shows no new brain metastasis or enlargement of existing brain metastasis, and all neurologic symptoms have stabilized or returned to normal), and do not require corticosteroid therapy or are receiving prednisone at a daily dose of ≤10 mg or equivalent doses of other corticosteroids, can participate in the study;\n3. Patients with a history of other malignant tumors within 3 years prior to randomization, except for the following conditions: cured skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, and cervical carcinoma in situ, etc.;\n4. Patients who are known to be allergic to any component of SYS6010 or to humanized monoclonal antibody products; allergic to carboplatin, cisplatin, or pemetrexed, or have contraindications for their use;\n5. AEs caused by prior anti-tumor treatment have not recovered to ≤ Grade 1 (excluding Grade 2 alopecia, peripheral neurotoxicity, and other toxicities judged by the investigator to have no safety risk) according to NCI-CTCAE v5.0;\n6. Previously received systemic anti-tumor therapy for locally advanced or metastatic non-squamous NSCLC other than EGFR TKI; patients who have previously received adjuvant\u002Fneoadjuvant chemotherapy and experienced disease progression more than 12 months after the end of treatment are allowed to be included;\n7. Patients who have not met the corresponding washout period requirements for the following medications or treatments should be excluded:\n\n   1. Major surgery (excluding needle biopsy)：At least 4 weeks\n   2. Small molecule targeted drugs, traditional Chinese medicines with anti-tumor indications, palliative radiation or local therapy：At least 2 weeks\n   3. intravenous injection of antibiotics, antifungals, or antivirals：At least 2 weeks\n   4. Investigational product and Live attenuated vaccine：At least 4 weeks\n   5. Strong CYP3A4 inducers or inhibitors ,OATP1B1 and OATP1B3 inhibitors：At least 2 weeks\n8. History of severe cardiovascular or cerebrovascular disease within 6 months prior to randomization, including but not limited to:\n\n   1. Presence of severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, third-degree atrioventricular block, Fridericia-corrected QT interval \\> 470 ms (Fridericia formula: QTcF = QT\u002FRR0.33, RR = 60\u002Fheart rate);\n   2. History of myocardial infarction, unstable angina pectoris, aortic dissection, angioplasty, or coronary artery bypass;\n   3. NYHA class II or higher cardiac failure, LVEF\\\u003C50% at screening;\n   4. Stroke or other Grade 3 or higher cardiovascular and cerebrovascular events;\n   5. Pulmonary embolism;\n9. Imaging examination suggests tumor invasion of the cervical, thoracic, and abdominal great vessels; and the investigator assessed that there was no risk of bleeding.\n10. Patients who have a history of ILD\u002Fnon-infectious pneumonitis treated with corticosteroids in the past, currently have ILD\u002Fnon-infectious pneumonitis, for whom imaging examinations at screening cannot rule out ILD\u002Fnon-infectious pneumonitis, or whose pulmonary function test indicates severe ventilatory dysfunction and\u002For decreased diffusion capacity;\n11. Presence of severe infections within 4 weeks prior to randomization, including but not limited to bacteraemia requiring hospitalisation, severe pneumonia, active pulmonary tuberculosis infection, etc.; presence of active infections requiring systemic antibiotics within 2 weeks prior to randomization;\n12. Previous permanent discontinuation of EGFR-targeted therapy due to skin toxicity, or currently have skin diseases requiring oral or intravenous medication;\n13. History of ulcerative colitis or Crohn's disease;\n14. Pleural effusion or pericardial effusion requiring clinical intervention within 2 weeks prior to randomization;\n15. Active HBV or HCV infection (hepatitis B surface antigen and\u002For hepatitis B core antibody positive and HBV DNA copies ≥ 1×104 copies\u002FmL or ≥ 2000 IU\u002FmL, HCV antibody positive and HCV RNA above the lower limit of detection of the analytical procedure). Note: For HBsAg-positive patients, it is recommended to start antiviral therapy before randomization, nucleoside analogues are recommended, such as entecavir, tenofovir disoproxil;\n16. History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases), history of allogeneic stem cell or organ transplant;\n17. Other conditions that the investigator deems unsuitable for participation in this clinical study (such as mental disorders, macular cystoid oedema, severe corneal disorders, uncontrolled or poorly controlled hypertension and diabetes mellitus).",{"count":220,"type":22},380,[74],"To evaluate the efficacy and safety of SYS6010 versus platinum-based chemotherapy in participants with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC)",[224],"EGFR-mutated Locally Advanced or Metastatic NSCLC",{"date":168,"type":33},{"date":227,"type":33},"2025-03-30",{"date":102,"type":22},{"name":39,"class":40},{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":70,"enrollmentInfo":237,"targetDuration":4,"studyType":23,"phases":239,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":247,"leadSponsor":249,"locationsCount":4},"100644485","phase-3-a-study-of-sys6010-plus-anti-pd-l-1-monoclonal-antibody-as-adjuvant-therapy-in-non-small-cell-lung-cancer-nsclc-100644485","NCT07672223","A Study of SYS6010 Plus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy in Non-small Cell Lung Cancer (NSCLC)","A Phase III, Randomized, Open-Label Study of SYS6010 in Combination With Anti-PD-(L)-1 Monoclonal Antibody Versus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy for Patients With Completely Resected Stage II-IIIB NSCLC Who Have No Actionable Genomic Alterations and Not Achieved a Major Pathological Response.","Inclusion Criteria:\n\n1. Able to understand and willingness to voluntarily provide written informed consent.\n2. Age 18 to 75 years, males or females.\n3. Histologically confirmed squamous or non-squamous NSCLC.\n4. Ability to provide qualified tumor samples.\n5. Without actionable genomic alterations (AGAs), which should be tested at a local or central laboratory.\n6. Did not achieve a Major Pathological Response (MPR) as assessed by the Central Pathology Independent Review Committee (CPIRC).\n7. The International Association for the Study of Lung Cancer (IASLC) V9 Stage II-IIIB NSCLC, after confirmed complete surgical resection with resection margins proved microscopically free of disease (R0).\n\nExclusion Criteria:\n\n1. Participants with a condition requiring further surgical resection, in the investigator's opinion.\n2. Participants with diagnosis of stage IIIB with N3, and stage IIIC, IVA, and IVB NSCLC.\n3. Eligible only for incomplete resection.\n4. Participants with synchronous primary lung cancer or multiple primary malignancies, or a mixed histology of SCLC and NSCLC.\n5. History of hypersensitivity or contraindication to any active or inactive excipient of the study treatment.\n6. Prior or planned neoadjuvant or adjuvant radiotherapy for the current malignancy.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":238,"type":22},570,[74],"The purpose of the study is to compare the efficacy and safety of SYS6010 in combination with anti-PD-(L)-1 monoclonal antibody vs. anti-PD-(L)-1 monoclonal antibody as adjuvant therapy for patients with. with completely resected stage II-IIIB, actionable genomic alterations (AGAs) negative non-small cell lung cancer (NSCLC) who did not achieve a major pathological response (MPR).",[242],"Non-small Cell Lung Cancer","2026-06-25",{"date":245,"type":33},"2026-06-26",{"date":243,"type":22},{"date":248,"type":22},"2031-11-30",{"name":39,"class":40},{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":23,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":41},"100642456","phase-2-a-clinical-study-of-sys6023-combination-therapy-for-advanced-breast-cancer-100642456","NCT07597629","A Clinical Study of SYS6023 Combination Therapy for Advanced Breast Cancer","A Phase II Clinical Study Evaluating the Efficacy and Safety of SYS6023 Combination Therapy for Unresectable Locally Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years old;\n* 2\\. Histologically or cytologically confirmed unresectable locally advanced or metastatic breast cancer:\n* 3\\. Sufficient tumor specimens must be provided for biomarker testing (human epidermal growth factor receptor 3-HER3), preferably obtained during or after the most recent treatment period; During safety run-in period, subjects who cannot provide sufficient tissue samples may be screened after sponsor's evaluation and approval;\n* 4\\. Documented disease progression or intolerability with the most recent systemic anti-tumor treatment;\n* 5\\. According to RECIST 1.1, at least one evaluable lesion (safety run-in period) or measurable lesion (cohort expansion phase);\n* 6\\. ECOG PS score 0-1;\n* 7\\. Expected survival ≥ 3 months;\n* 8\\. Adequate organ function with laboratory tests meeting criteria (no blood transfusion or hematopoietic growth factor therapy within 14 days before testing): ANC ≥ 1.5 × 10\\^9\u002FL PLT ≥ 100 × 10\\^9\u002FL Hb ≥ 90 g\u002FL TBIL ≤ 1.5 × ULN ALT, AST ≤ 2.5 × ULN; for participants with liver metastasis, ALT and AST ≤ 5 × ULN Creatinine clearance rate (Ccr) \\> 35 mL\u002Fmin (calculated according to Cockcroft-Gault formula) Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; International normalized ratio (INR) ≤ 1.5 × ULN Left ventricular ejection fraction (LVEF) ≥ 55% (only applicable to Cohort 2)\n* 9\\. Eligible individuals with reproductive potential must agree to use reliable contraceptive methods (hormonal contraceptives, barrier methods, or abstinence) with their partners during the trial and for at least 7 months after the last dose; Women of childbearing potential must have a negative blood pregnancy test within 7 days before enrollment;\n* 10\\. Fully understand this clinical trial and voluntarily sign the written informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Prior treatment with HER3-targeted ADC therapy;\n* 2\\. Applicable to Cohort 1: a. Prior treatment with any topoisomerase I inhibitor-loaded ADC therapy; b. Current presence or impending visceral crisis that has caused or may cause impending organ damage and\u002For other life-threatening complications;\n* 3\\. Applicable to Cohort 2: a. Prior exposure to anthracyclines with cumulative dose exceeding 360 mg\u002Fm\\^2doxorubicin equivalent; b. LVEF once dropped to \\\u003C 40% during prior anti-HER2 drug therapy, or symptomatic CHF occurred;\n* 4\\. History of other malignancies within 3 years before randomization\u002Ffirst dose or concurrent active malignancies (except cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc., which are allowed to enroll);\n* 5\\. Untreated (including those detected during screening period) or unstable brain parenchymal metastasis, spinal cord metastasis or compression, carcinomatous meningitis. Subjects with treated stable brain metastases may be considered for enrollment (Note: refers to participants who have received local brain treatment, whose symptoms are stable, imaging tests show stability for at least 28 days before randomization\u002Ffirst dose, no evidence of progressive brain edema, and no need for glucocorticoids or other symptom control measures);\n* 6\\. Adverse reactions from prior anti-tumor therapy have not recovered to CTCAE 6.0 grade ≤ 1 (except for toxicities such as alopecia that researchers judge to have no safety risk);\n* 7\\. Major surgery within 28 days before randomization\u002Ffirst dose, or planned to undergo systemic or local tumor resection during the study period;\n* 8\\. History of severe bleeding risk (e.g., gastrointestinal varices) or bleeding diathesis, any gastrointestinal bleeding or other bleeding of ≥ CTCAE grade 2 within 28 days before randomization\u002Ffirst dose; Abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 months before randomization\u002Ffirst dose;\n* 9\\. History of severe cardiovascular disease, including but not limited to:\n\n  1. Acute coronary syndrome within 6 months before randomization\u002Ffirst dose;\n  2. Stroke or transient ischemic attack within 6 months before randomization\u002Ffirst dose;\n  3. Pulmonary embolism or deep vein thrombosis within 3 months before randomization\u002Ffirst dose (intermuscular vein thrombosis may be enrolled if assessed as low risk by researchers);\n  4. CHF with NYHA functional classification ≥ II;\n  5. Documented history of cardiomyopathy that has not currently recovered;\n  6. Pericarditis;\n  7. Severe arrhythmia, such as ventricular arrhythmia requiring clinical intervention, II-III degree atrioventricular block, etc.;\n  8. Baseline average QTcF \\> 450 ms (calculated using Fridericia formula), or history or family history of long QT syndrome;\n  9. Uncontrolled hypertension (defined as persistent systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg despite antihypertensive medication);\n* 10\\. Presence of non-infectious lung disease\u002Fpneumonia requiring treatment at randomization\u002Ffirst dose, or history of interstitial lung disease\u002Fpneumonia requiring glucocorticoid treatment during prior anti-tumor therapy;\n* 11\\. Active bacterial, fungal or viral infection within 14 days before randomization\u002Ffirst dose (defined as requiring intravenous anti-bacterial, anti-fungal or anti-viral drug therapy). Individuals receiving prophylactic anti-infective therapy without clinical manifestations of active infection may be considered for enrollment;\n* 12\\. Active hepatitis B or hepatitis C, defined as HBsAg positive and HBV DNA \\> 2000 IU\u002FmL for active hepatitis B; defined as HCV-Ab positive and HCV RNA \\> ULN for active hepatitis C;\n* 13\\. History of immunodeficiency or positive HIV antibody test during screening;\n* 14\\. Use of strong CYP3A4 inducers or inhibitors, OATP1B1 or OATP1B3 inhibitors before randomization\u002Ffirst dose (within 5 half-lives of inducer or inhibitor) or need to use such drugs during study treatment;\n* 15\\. Known or suspected hypersensitivity to the study drug or its components;\n* 16\\. Lactating women;\n* 17\\. Presence of other conditions that may interfere with participants' participation in study procedures, not in line with participants' maximum benefit from participating in the study, or affect study results: such as history of mental illness, drug abuse or substance abuse, any other clinically significant disease or condition, etc.",{"count":258,"type":22},36,[52],"This is an open-label, multicenter Phase II clinical study conducted in subjects with advanced breast cancer.",[262],"Advanced Breast Cancer","2026-06-15",{"date":265,"type":33},"2026-06-16",{"date":267,"type":33},"2026-05-25",{"date":269,"type":22},"2029-05-30",{"name":39,"class":40},{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":70,"enrollmentInfo":278,"targetDuration":4,"studyType":23,"phases":280,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":290,"locationsCount":4},"100642904","phase-3-sys6010-combined-with-enlonstobart-versus-immunotherapy-platinum-based-chemotherapy-for-patients-with-pd-l1-positive-locally-advanced-or-metastatic-nsclcsynstar-04-100642904","NCT07633873","SYS6010 Combined With Enlonstobart Versus Immunotherapy+ Platinum-based Chemotherapy for Patients With PD-L1-Positive Locally Advanced or Metastatic NSCLC（SYNSTAR 04）","An Open-label, Multicenter Randomized Phase III Study of SYS6010 Combined With Enlonstobart Versus Immunotherapy+ Platinum-based Chemotherapy as First-Line Treatment for Patients With PD-L1-Positive Locally Advanced or Metastatic NSCLC","Inclusion Criteria:\n\n1. Aged 18-75 (inclusive) years old, male or females;\n2. Participants with pathologically confirmed locally advanced or metastatic NSCLC. Including participants with stage IIIB or IIIC according to the 9th edition of AJCC staging who are not suitable for surgical resection or radical chemoradiotherapy, or participants with stage IV NSCLC\n3. Participants who have not previously received systemic anti-tumor treatment. Those who have previously received adjuvant\u002Fneoadjuvant therapy will be allowed for inclusion if disease progression occurs 12 months after the end of treatment.\n4. EGFR mutation negative and ALK fusion negative\n5. Participants with PD-L1 TPS≥1% according to centralized laboratory test\n6. At least one measurable lesion confirmed by CT or MRI scan according to RECIST v1.1 criteria\n7. ECOG performance status of 0-1;\n8. Life expectancy ≥ 3 months;\n9. Major organ function must meet the criteria within 7 days prior to the first dose of the study intervention\n10. Women of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose. Participants must agree to use effective contraception from the time of signing the informed consent form until 7 months after the last dose; during this period, women should not be breastfeeding, and men should avoid donating sperm;\n11. Voluntarily participate in this clinical study, understand the study procedures, and be able to sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Histology or cytology of the tumor confirms the presence of combined small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid carcinoma;\n2. Participants with ROS1\u002FRET\u002FNTRK fusions, MET exon 14 skipping mutation, or BRAF V600E mutation.\n3. Participants with meningeal metastasis, brainstem metastasis, spinal cord metastasis and\u002For compression, or active CNS metastasis. Patients with supratentorial and\u002For cerebellar metastasis (i.e., without mesencephalon, pons, or medulla involvement) who have received local treatment, have achieved stability for at least 2 weeks prior to the first dose of the study intervention (imaging shows no new brain metastasis or enlargement of existing brain metastasis, and all neurologic symptoms have stabilized or returned to normal), and do not require corticosteroid therapy or are receiving prednisone at a daily dose of ≤10 mg or equivalent doses of other corticosteroids, can participate in the study;\n4. Participants with a history of other malignant tumors within 3 years prior to the first dose of the study intervention, except for the following conditions: cured skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, and cervical carcinoma in situ, etc.;\n5. Participants who are known to be allergic to any component of SYS6010, Enlonstobart, Tislelizumab or to humanized monoclonal antibody products or ; Paclitaxel\u002FCarboplatin\u002F Pemetrexed\u002FCisplatin.\n6. Previously treated with topoisomerase I inhibitor toxin ADC therapy\n7. AEs caused by prior anti-tumor treatment have not recovered to ≤ Grade 1 (excluding Grade 2 alopecia and other toxicities judged by the investigator to have no safety risk) according to NCI-CTCAE v6.0; Participants who experienced ≥ grade 3 irAEs during previous treatment, or who permanently discontinued medication due to irAEs\n8. Patients who have not met the corresponding washout period requirements for the medications or treatments should be excluded；\n9. History of severe cardiovascular or cerebrovascular disease within 6 months prior to the first dose of the study intervention\\\\\n10. Patients who have a history of ILD\u002Fnon-infectious pneumonitis treated with corticosteroids in the past, currently have ILD\u002Fnon-infectious pneumonitis, for whom imaging examinations at screening cannot rule out ILD\u002Fnon-infectious pneumonitis, or whose pulmonary function test indicates severe ventilatory dysfunction and\u002For decreased diffusion capacity;\n11. Presence of severe infections within 4 weeks prior to the first dose of the study intervention, including but not limited to bacteraemia requiring hospitalisation, severe pneumonia, active pulmonary tuberculosis infection, etc.; presence of active infections requiring systemic antibiotics within 2 weeks prior to the first dose of the study intervention;\n12. Participants with active autoimmune diseases or a history of autoimmune diseases (such as ulcerative colitis or Crohn's disease) are excluded, but participants with the following conditions are allowed to proceed to further enrollment screening: well-controlled type 1 diabetes and hypothyroidism that is well-controlled with only hormone replacement therapy.\n13. Pleural effusion or pericardial effusion requiring clinical intervention within 2 weeks prior to the first dose;\n14. Active HBV or HCV infection (hepatitis B surface antigen and\u002For hepatitis B core antibody positive and HBV DNA copies ≥ 1×10\\^4 copies\u002FmL or ≥ 2000 IU\u002FmL, HCV antibody positive and HCV RNA above the lower limit of detection of the analytical procedure). Note: For HBsAg-positive patients, it is recommended to start antiviral therapy before the first dose of the study intervention, nucleoside analogues are recommended, such as entecavir, tenofovir disoproxil;\n15. History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases), history of allogeneic stem cell or organ transplant;\n16. Other conditions that the investigator deem unsuitable for participation in this clinical study. Such as mental illness, uncontrolled or poorly controlled hypertension (defined as systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥95 mmHg after standardized antihypertensive treatment), and diabetes, etc.",{"count":279,"type":22},500,[74],"This study was an open-label, multi-center, randomized phase III study to evaluate the efficacy and safety of SYS6010 combined with Enlonstobart versus Immunotherapy+ Platinum-based chemotherapy as First-Line treatment for patients with PD-L1-Positive locally advanced or metastatic NSCLC.",[283],"Non-Small Cell Lung Cancer","2026-06-09",{"date":286,"type":33},"2026-06-11",{"date":288,"type":22},"2026-06-02",{"date":269,"type":22},{"name":39,"class":40},{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":23,"phases":300,"briefSummary":301,"conditions":302,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":4},"100638092","phase-1-sys6006-in-combination-with-enlonstobart-injection-versus-enlonstobart-injection-in-participants-with-advanced-solid-tumors-100638092","NCT07622225","SYS6006 in Combination With Enlonstobart Injection Versus Enlonstobart Injection in Participants With Advanced Solid Tumors","A Phase Ib\u002FII Clinical Study to Evaluate the Safety and Efficacy of SYS6006 in Combination With Enlonstobart Injection Versus Enlonstobart Injection in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\. Able to understand and voluntarily sign the written informed consent form (ICF);\n* 2\\. Male or female subjects aged over 18 years old (inclusive).\n* 3\\. Patients with solid tumor who have unresectable locally advanced or metastatic disease;\n* 4\\. At least one measurable lesion, as defined by RECIST 1.1 criteria;\n* 5\\. ECOG performance status of 0-2;\n* 6\\. Expected survival ≥ 3 months;\n* 7\\. Adequate function of major organs and bone marrow;\n* 8\\. Women or man of childbearing potential must use highly effective contraception.\n\nExclusion Criteria:\n\n* 1\\. Patients with metastases to meninges; with spinal cord compression; symptomatic and unstable brain metastasis;\n* 2\\. Patients with a history of autoimmune diseases;\n* 3\\. Presence of active infection (e.g., subjects are receiving anti-infection therapy);\n* 4\\. Severe or uncontrolled cardiovascular disorder requiring treatment;\n* 5\\. Women who are pregnant or breastfeeding.",{"count":299,"type":22},264,[25,52],"This study is a Phase Ib\u002FII clinical study. It includes two stages: Phase Ib and Phase II. In the Phase Ib stage, the primary objective is to evaluate the safety and tolerability of SYS6006 in combination with Enlonstobart Injection in participants with advanced solid tumors, and to provide a basis for dose selection in later clinical studies. The primary objective of the Phase II stage is to assess efficacy and safety of SYS6006 in combination with Enlonstobart Injection in participants with advanced solid tumors.",[117],"2026-05-30",{"date":305,"type":33},"2026-06-03",{"date":307,"type":22},"2026-05-29",{"date":309,"type":22},"2030-01-31",{"name":39,"class":40},{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":317,"eligibilityCriteria":318,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":70,"enrollmentInfo":319,"targetDuration":4,"studyType":23,"phases":321,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":4},"100621881","phase-3-a-phase--clinical-study-of-sys6010-in-combination-with-osimertinib-in-patients-with-locally-advanced-or-metastatic-nsclc-100621881","NCT07376382","A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLC","A Randomized, Open-label, Multicenter, Phase III Clinical Trial to Evaluate the Safety and Efficacy of SYS6010 in Combination With Osimertinib in Patients With EGFR-mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer","SYNSTAR-02","Inclusion Criteria:\n\n1. Age 18 \\~ 75 (inclusive) years old, regardless of gender;\n2. Patients with pathologically confirmed locally advanced or metastatic NSCLC, including: patients with stage IIIB or IIIC based on AJCC staging version 8 who are not suitable for surgical resection or radical chemoradiotherapy, or patients with stage IV NSCLC. For the dose escalation phase, patients must have EGFR-mutant locally advanced or metastatic NSCLC that has failed previous standard therapy, and for the dose selection phase and phase III study, patients must have EGFR-mutant locally advanced or metastatic NSCLC, which has not received EGFR-TKIs or other systemic therapy before. Patients who have received adjuvant\u002Fneoadjuvant chemotherapy may be included if disease progression occurred at least 6 months after completing treatment;\n3. Carry at least one EGFR-sensitive mutation (ex19del or L858R, which can be combined with other EGFR mutations). EGFR mutation: Stage Ib: can be enrolled based on previous test results. Phase III: Take the test results of the central laboratory as the admission group;\n4. At least one measurable lesion confirmed by CT or MRI, as defined by RECIST v1.1 criteria;\n5. ECOG performance status score 0-1;\n6. Expected survival ≥ 3 months;\n7. Major organ function meets the relevant laboratory test standards for hematology, renal function, liver function, and coagulation within 7 days prior to treatment;\n8. Women of childbearing age had a negative blood pregnancy test within 7 days prior to the first use of study drug. Participants must agree to take effective contraceptive measures from signing the informed consent form to 7 months after the last dose, during which women are non-breastfeeding and men avoid sperm donation;\n9. Volunteer to participate in this clinical study, understand the study procedures, and be able to sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Patients with meningeal metastases, brainstem metastases, spinal cord metastases and\u002For compression, or active CNS metastases;\n2. History of other malignant tumors within 3 years prior to the first use of study drug, except for the following conditions: cured skin basal cell or squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, or cervical carcinoma in situ, etc.;\n3. Known allergies to SYS6010 or any ingredient of Osimertinib, or to humanized monoclonal antibodies;\n4. Adverse events caused by prior anti-tumor therapy that have not resolved to ≤ Grade 1 (as per NCI-CTCAE v6.0), except for Grade 2 alopecia or peripheral neuropathy deemed by the investigator not to pose a safety risk;\n5. Use of any of the medications or treatments within the specified washout period (prior to first dose of study drug)\n6. History of serious cardiovascular or cerebrovascular conditions within 6 months prior to the first dose, including but not limited to:Severe arrhythmias (e.g., ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, QTcF \\> 470 ms) (Fridericia formula: QTcF = QT\u002FRR0.33, RR = 60\u002Fheart rate). Myocardial infarction, unstable angina, aortic dissection, angioplasty, or coronary artery bypass surgery. NYHA class II or higher heart failure with LVEF \\\u003C 50%.Stroke or other grade ≥ 3 cardiovascular\u002Fcerebrovascular events. pulmonary embolism.\n7. Patients who have a history of ILD\u002Fnon-infectious pneumonitis treated with corticosteroids in the past, currently have ILD\u002Fnon-infectious pneumonitis, for whom imaging examinations at screening cannot rule out ILD\u002Fnon-infectious pneumonitis, or whose pulmonary function test indicates severe ventilatory dysfunction and\u002For decreased diffusion capacity;\n8. Severe infection within 4 weeks prior to the first dose, such as bacteremia requiring hospitalization, severe pneumonia, or active pulmonary tuberculosis; Active systemic infections requiring antibiotics within 2 weeks prior to administration;\n9. Currently suffering from a skin condition requiring oral or vein administration;\n10. Participants with active autoimmune disease or a history of autoimmune disease (e.g., ulcerative colitis or Crohn's disease) are excluded from the study. However, participants with the following conditions may be considered eligible for further screening: those with well-controlled type 1 diabetes, well-controlled hypothyroidism requiring only hormone replacement therapy, skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or diseases unlikely to relapse even when exposed to external triggers;\n11. Pleural or peritoneal effusion or pericardial effusion requiring clinical intervention;\n12. Conditions that seriously affect gastrointestinal absorption as judged by the investigator (such as Persistent nausea, vomiting, chronic gastrointestinal diseases, gastrointestinal surgery, etc.);\n13. Active HBV or HCV infection (hepatitis B surface antigen and\u002For hepatitis B core antibody positive and HBV DNA copy number ≥ 1 × 104 copy number\u002FmL or ≥ 2000 IU\u002FmL, HCV antibody positive and HCV RNA higher than the lower detection limit of the analytical method), Note: For HBsAg positive, it is recommended to start antiviral therapy before the first use of study drug, and Nucleosides analogs such as Entecavir and Tenofovir disoproxil are recommended);\n14. History of immunodeficiency (including positive HIV test, other acquired, congenital immunodeficiency diseases), history of allogeneic stem cell or organ transplantation;\n15. Other conditions (e.g. mental illness, macular cystic edema, severe corneal diseases, uncontrolled or poorly controlled hypertension and diabetes, active bleeding, etc.) that the investigator considers inappropriate to participate in this clinical trial.",{"count":320,"type":22},680,[74],"This study is a randomized, open-label, multicenter Phase III clinical trial evaluating patients with EGFR-mutant locally advanced or metastatic NSCLC. The Phase III study is planned to enroll approximately 680 participants, who will be randomized in a 1:1 ratio into the following groups:\n\nTest group: SYS6010 + osimertinib Control group: Investigator's choice of one treatment（Osimertinib or Osimertinib+ Chemotherapy）",[324],"NSCLC","2026-05-11",{"date":327,"type":33},"2026-05-13",{"date":329,"type":22},"2026-06-01",{"date":331,"type":22},"2029-06-06",{"name":39,"class":40},{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":23,"phases":342,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":4},"100640375","phase-1-a-study-of-sys6051-in-subjects-with-advanced-solid-tumors-100640375","NCT07591285","A Study of SYS6051 in Subjects With Advanced Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SYS6051 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Fully understand the clinical study and voluntarily sign the written ICF;\n2. Age ≥ 18 years;\n3. Have at least one measurable lesion according to RECIST 1.1;\n4. ECOG performance status score of 0 to 1;\n5. Have adequate organ function;\n6. Expected survival of at least 3 months;\n7. Eligible participants of childbearing potential must agree to use a reliable method of contraception with their partner during the study and for at least 4 months (males) or 7 months (females) after the last dose. Female participants of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose;\n8. Histologically or cytologically confirmed diagnosis of advanced solid tumors. -\n\nExclusion Criteria:\n\n1\\. Presence of high bleeding risk factors; 2. Presence of active ocular disease; 3. Patients with other active malignant tumors; 4. Uncontrolled serous effusions requiring frequent drainage or medical intervention within 14 days prior to the first dose; 5. Serious chronic or active infection; 6. Surgical on vital organs within 4 weeks prior to the first dose or planned systemic or local tumor resection during the study; 7. Untreated (including baseline findings) or unstable parenchymal metastases, spinal cord metastases or compression, carcinomatous meningitis; 8. History of non-infectious lung disease\u002Fpneumonitis requiring steroid hormone therapy or current interstitial lung disease\u002Fpneumonitis or suspected by imaging during screening; 9. History of significant cardiovascular disease; 10. History of immunodeficiency, Active hepatitis B or hepatitis C; 11. Known serious allergic reactions to the study drug or other ingredients and excipients in the formulation; 12. Pregnant or lactating women; 13. Presence of other conditions that could interfere with the participant 's participation in study procedures or would not be in the best interest of the participant' s participation in the study or affect the study results: such as a history of mental illness, drug use, or drug abuse, any other clinically significant disease or condition.\n\n\\-",{"count":341,"type":22},114,[25],"This is a multicenter, open-label, dose-escalation and backfill, and cohort-expansion phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor efficacy of SYS6051 in participants with advanced solid tumors.",[117],"2026-05-09",{"date":347,"type":33},"2026-05-15",{"date":349,"type":22},"2026-05-12",{"date":351,"type":22},"2028-06-30",{"name":39,"class":40},{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":70,"enrollmentInfo":360,"targetDuration":4,"studyType":23,"phases":362,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":4},"100633446","phase-3-sys6002-vs-chemotherapy-in-patients-with-locally-advanced-or-metastatic-urothelial-carcinoma-100633446","NCT07526792","SYS6002 vs Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma","A Randomized, Controlled, Open-Label, Multicenter Phase 3 Trial of SYS6002 Versus Investigator's Choice Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma After Failure of Platinum-based Chemotherapy andPD-(L)1 Inhibitors","Inclusion Criteria:\n\n* 1.Participantss aged 18-75 years (inclusive);\n* 2\\. Pathologically confirmed patients with locally advanced or metastatic urothelial carcinoma\n* 3 Participants havefailed of platinum-based chemotherapy and PD-(L)1 inhibitors; for participants who received platinum-based chemotherapy and PD-(L)1 inhibitors in the adjuvant\u002Fneoadjuvant setting, disease recurrence or progression must have occurred within 12 months after completion of that therapy; radiographically confirmed disease progression during or after the most recent treatment regimen;\n* 4 Participants must have measurable disease according to RECIST (version 1.1);\n* 5 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n* 6 Life expectancy of ≥ 3 months;\n* 7 Adequate major organ function (hematology, renal, liver, and coagulation) as determined by laboratory tests performed within 7 days prior to treatment;\n* 8 Sexually active fertile participants must agree to use methods of contraception during the study and at least 6 months after termination of study therapy and have a negative urine or serum pregnancy test within 7 days prior to randomization;\n* 9 Willing to participate in the study, understand the study procedures, and sign a written informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Active central nervous system metastases or leptomeningeal metastasis;\n* 2\\. Prior Nectin-4-targeted therapy;\n* 3\\. Adverse events from prior antitumor therapy not recovered to Grade ≤ 1 per NCI-CTCAE v5.0；\n* 4\\. Any serious and\u002For uncontrolled concurrent illness that may interfere with patient's participation in the study:\n\n  1. History of severe cardiovascular disease within 6 months prior to randomization, including but not limited to:\n\n     1. Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia and third-degree atrioventricular block requiring clinical intervention; corrected QT interval \\> 480 ms by Fridericia method (Fridericia formula: QTcF = QT\u002FRR\\^0.33, RR = 60\u002Fheart rate);\n     2. With history of myocardial infarction, unstable angina pectoris, angioplasty and coronary artery bypass surgery;\n     3. New York Heart Association (NYHA) classification Grade III and above heart failure, and left ventricular ejection fraction (LVEF) \\\u003C 50% in the tests and examinations during the screening period;\n     4. Ischemic or Hemorrhagic Stroke;\n     5. Pulmonary Embolism Accident;\n  2. Other clinically significant diseases:\n\n     1. HbA1c \\> 8%;\n     2. Participants with active keratitis and corneal ulcer, or fundus lesions with a risk of blindness;\n     3. Grade ≥2 neuropathy prior to randomization;\n     4. Severe infection within 4 weeks prior to randomization; Active infection of Grade ≥2 (CTCAE v5.0) requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to randomization;\n     5. Active HBV or HCV infection;\n     6. History of immunodeficiency (HIV-positive, acquired or congenital immunodeficiency, etc.), or organ transplantation;\n     7. History of another malignancy within 3 years prior to randomization;\n     8. History of interstitial lung disease (ILD) \u002F non-infectious pneumonia, or current ILD\u002Fnon-infectious pneumonia, or imaging findings at screening that cannot rule out these condition, except for those who are determined to be risk-free after discussion between the investigator and the sponsor;\n     9. Pleural effusion, ascites or pericardial effusion with syptoms or requiring puncture or drainage within 2 weeks prior to randomization;\n* 5\\. Use of other unmarketed clinical investigational drugs or treatments, chemotherapy, radiotherapy, or targeted therapy within 4 weeks prior to randomization; use of traditional Chinese medicine with anticancer indication, oral fluoropyrimidine drugs, small molecule targeted drug within 2 weeks prior to randomization; use of palliative radiation or local therapy within 2 weeks prior to randomization; or major surgery within 4 weeks prior to randomization;\n* 6\\. Allergy to any component of SYS6002 or to humanized monoclonal antibodies;\n* 7\\. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.",{"count":361,"type":22},406,[74],"This study is a randomized, controlled, open-label, multicenter phase III clinical trial, which aims to evaluate the efficacy,safety PK characteristics, and immunogenicity of SYS6002 compared with chemotherapy in participants with locally advanced or metastatic urothelial carcinoma.\n\nThis study has not yet been submitted for ethical review. The current registration is a pre-registration. Recruitment will commence only after formal approval is obtained from the relevant Ethics Committee).",[365],"Urothelial Carcinoma","2026-04-07",{"date":368,"type":33},"2026-04-13",{"date":370,"type":22},"2026-06-20",{"date":372,"type":22},"2029-12-01",{"name":39,"class":40},{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":23,"phases":384,"briefSummary":385,"conditions":386,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":4},"100626971","phase-3-sys6010-versus-docetaxel-for-previously-treated-egfr-wild-type-nsclc-phase--100626971","NCT07442565","SYS6010 Versus Docetaxel for Previously Treated EGFR Wild-type NSCLC: Phase Ⅲ","A Randomized, Open-label, Multicenter Phase III Study Comparing SYS6010 With Docetaxel in Patients With Locally Advanced or Metastatic EGFR Wild-type Non-squamous Non-small Cell Lung Cancer Who Have Failed Standard Therapy","SYNSTAR03","Inclusion Criteria:\n\n1\\. Voluntarily participate in this clinical study, understand the study procedures, and be able to sign the written ICF (Informed Consent Form); 2. Age ≥18 years, with no restriction on sex; 3. Patients with pathologically confirmed locally advanced or metastatic EGFR wild-type non-squamous non-small cell lung cancer (nsq-NSCLC). Stage IIIB or IIIC patients unsuitable for surgical resection or radical chemoradiotherapy, or Stage IV NSCLC patients. EGFR mutations (currently approved by regulatory authorities for targeted therapy) must be confirmed negative. If test results are unavailable, participants need to provide tumor tissue to undergo genetic testing.\n\n4\\. Meet either of the following requirements regarding prior treatment for locally advanced or metastatic EGFR wild-type nsq-NSCLC:\n\n1. Driver gene-negative population must have failed only immune therapy and platinum-based chemotherapy ± anti-angiogenic therapy (limited to first-line regimens approved by regulatory authorities).\n2. Other driver gene-positive populations must have received and failed only targeted therapy for the driver gene and platinum-based chemotherapy ± anti-angiogenic therapy (limited to first-line regimens approved by regulatory authorities).\n\n   5\\. Have at least one measurable lesion confirmed by CT or MRI according to RECIST v1.1 criteria; 6. ECOG performance status score 0-1; 7. Expected survival ≥3 months as judged by the investigator. 8. Within 7 days before the first administration, the body organs and bone marrow function meet the requirements, defined as follows (Note: For hematological tests, participants must not have received blood component transfusion, G-CSF, TPO, TPO-RA, IL-11, or EPO within 2 weeks prior to randomization):\n   1. ANC ≥1.5×10⁹\u002FL\n   2. Platelets (PLT) ≥100×10⁹\u002FL\n   3. Hemoglobin (HGB) ≥100 g\u002FL\n   4. Serum creatinine (Cr) ≤1.5×ULN AND creatinine clearance ≥50 mL\u002Fmin (calculated by Cockcroft-Gault formula)\n   5. Total bilirubin (TBIL): ≤1.5×ULN for patients without liver metastases; ≤3×ULN for patients with Gilbert's syndrome or liver metastases\n   6. ALT\u002FAST: ≤2.5×ULN for patients without liver metastases; ≤5×ULN for patients with liver metastases\n   7. APTT and INR ≤1.5×ULN 9. Female participants of childbearing potential must have a negative pregnancy test within 7 days before randomization. All participants must agree to use effective contraception from the time of signing the ICF until 7 months after the last dose. During this period, female participants must not be breastfeeding, and male participants must refrain from sperm donation.\n\n   Exclusion Criteria:\n   1. Histologically or cytologically confirmed small cell lung cancer, squamous cell carcinoma, neuroendocrine carcinoma, or sarcomatoid carcinoma\n   2. Patients with: Leptomeningeal metastasis, brainstem metastasis, spinal cord metastasis and\u002For compression, or active CNS metastases.\n\n      Exception: Supratentorial and\u002For cerebellar metastases (excluding midbrain, pons, or medulla) are allowed if: Received local therapy (e.g., radiation\u002Fsurgery) Stable for ≥2 weeks before randomization (no new lesions\u002Fenlargement on imaging, stable\u002Fimproved neurological symptoms). No corticosteroids or ≤10 mg prednisone (or equivalent) daily.\n   3. Other malignancies within 3 years before randomization, except: Cured basal\u002Fsquamous cell skin cancer, superficial bladder cancer, prostate\u002Fcervical carcinoma in situ.\n   4. Known allergies: To any component of SYS6010 or humanized monoclonal antibodies. Contraindications\u002Fhypersensitivity to docetaxel.\n   5. Residual toxicities from prior antitumor therapy \\> Grade 1 (per NCI-CTCAE v6.0), except: Grade 2 alopecia or other toxicities deemed non-risky by investigators.\n   6. Prior treatment with topoisomerase I inhibitors (including ADCs).\n   7. Inadequate washout periods:\n\n   \u003C!-- -->\n\n   1. Major surgery (excluding biopsies) within 4 weeks before first dose.\n   2. Last antitumor therapy before first dose:\n\n      Chemotherapy\u002Fradical radiotherapy\u002Ftargeted\u002Fimmunotherapy: ≥4 weeks. Small-molecule targeted drugs\u002FTCM with antitumor claims\u002Fpalliative radiotherapy\u002Flocal therapy: ≥2 weeks.\n   3. Within 2 weeks before first dose: IV antibiotics\u002Fantifungals\u002Fantivirals for the purpose of anti-infective therapy; strong CYP3A4 inducers\u002Finhibitors; OATP1B1\u002F1B3 inhibitors.\n   4. Investigational drugs\u002Flive vaccines within 4 weeks before first dose. 8. Severe cardiovascular diseases within 6 months before randomization, including: Clinically significant arrhythmias (e.g., ventricular arrhythmia, AV block ≥ Grade III); QTcF \\>470 ms (Fridericia's formula) Myocardial infarction, unstable angina, aortic dissection, angioplasty, CABG. Heart failure ≥ NYHA Class II or LVEF \\\u003C50%. Stroke or Grade ≥3 cardiovascular events. Pulmonary embolism. 9. History of ILD\u002Fnon-infectious pneumonitis requiring steroids; current ILD; or suspected ILD on imaging\u002Fpulmonary function tests (severe ventilation\u002Fdiffusion impairment).\n\n   10\\. Severe infections within 4 weeks before randomization (e.g., bacteremia, severe pneumonia, active TB); active infections requiring IV antibiotics within 2 weeks.\n\n   11\\. History of ulcerative colitis or Crohn's disease. 12. Pleural\u002Fpericardial effusion requiring intervention within 2 weeks. 13. Active HBV\u002FHCV infection: HBV: HBsAg+ and\u002For HBcAb+ with HBV DNA ≥10⁴ copies\u002FmL (or ≥2000 IU\u002FmL).\n\n   HCV: HCV Ab+ with HCV RNA above detection limit. Note: Antiviral therapy (e.g., entecavir\u002Ftenofovir) is recommended for HBsAg+ patients before randomization.\n\n   14\\. Immunodeficiency (HIV+, congenital\u002Facquired immune disorders) or allogeneic transplant history.\n\n   15\\. Other conditions deemed ineligible by investigators (e.g., uncontrolled psychiatric disorders, hypertension\u002Fdiabetes).",{"count":383,"type":22},506,[74],"This is a randomized, open-label, multicenter Phase III clinical trial, designed to evaluate the efficacy and safety of SYS6010 versus docetaxel in participants with Locally Advanced or Metastatic EGFR Wild-type Non-squamous Non-small Cell Lung Cancer who Have Failed Standard Therapy. The primary Objective is to evaluate the efficacy of SYS6010 versus docetaxel in participants with EGFR wild-type locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC). Secondary Objectives includes safety, quality of life, immunogenicity, biomarkers, and efficacy correlations of SYS6010 compared to docetaxel in the same patient population.",[283],"2026-03-02",{"date":389,"type":33},"2026-03-04",{"date":391,"type":22},"2026-03-10",{"date":393,"type":22},"2031-05-30",{"name":39,"class":40},{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":23,"phases":404,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":414,"locationsCount":4},"100625061","phase-3-sys6010-versus-chemotherapy-in-locally-advanced-or-metastaticrecurrent-esophageal-squamous-cell-carcinoma-100625061","NCT07417735","SYS6010 Versus Chemotherapy in Locally Advanced or Metastatic\u002FRecurrent Esophageal Squamous Cell Carcinoma","A Randomized, Controlled, Open-Label, Multicenter Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of SYS6010 Versus Investigator's Choice Chemotherapy in Patients With Locally Advanced or Metastatic\u002FRecurrent Esophageal Squamous Cell Carcinoma Who Have Failed at Least One Line of Systemic Therapy.","Inclusion Criteria:\n\n1. Voluntarily sign the Informed Consent Form (ICF);\n2. Aged ≥18 years at the time of ICF signing, regardless of gender;\n3. Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC) with unresectable locally advanced disease, local recurrence, or distant metastasis;\n4. Subjects with disease progression or intolerance after at least one line of systemic therapy.\n5. At least one evaluable lesion meeting the criteria of RECIST 1.1;\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n7. Expected survival≥3 months;\n8. Major organ functions meeting the prespecified criteria within 3 days prior to randomization\n9. Male participants and female participants of childbearing potential must agree to adopt effective contraceptive measures from the time of signing the ICF until 7 months after the last dose; during this period, female participants must not be breastfeeding and male participants must refrain from sperm donation. Female participants of childbearing potential must have a negative blood pregnancy test within 7 days prior to randomization.\n\nExclusion Criteria:\n\n1. A past pathological diagnosis of esophageal cancer with adenocarcinoma, adenosquamous carcinoma, or other pathological types.\n2. Active central nervous system (CNS) metastasis and\u002For meningeal metastasis. Subjects with supratentorial and\u002For cerebellar (i.e., no midbrain, pons, or medulla oblongata) metastasis who achieve stable disease for at least 4 weeks prior to randomization after local therapy (imaging shows no new brain metastases or no enlargement of existing brain metastatic lesions, and all neurological symptoms are stable or return to normal), and who do not require glucocorticoid therapy or are receiving a daily prednisone dose of ≤10 mg or an equivalent dose of other glucocorticoids, are eligible for the study.\n3. Receipt of any anti-tumor therapy (including but not limited to chemotherapy, immunotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks prior to randomization, with the exception of the following:\n\n   1. Receipt of oral chemotherapeutic agents or small-molecule targeted therapy agents within 2 weeks prior to randomization or within 5 half-lives of the drug (whichever is shorter);\n   2. Receipt of traditional Chinese medicine (TCM) or proprietary Chinese medicines with anti-tumor indications within 2 weeks prior to randomization;\n   3. Receipt of local palliative radiotherapy for the purpose of relieving bone metastasis pain within 2 weeks prior to randomization;\n   4. Receipt of major surgical treatment (excluding needle biopsy), participation in other clinical trials with study drug administration, or vaccination with live-attenuated vaccines within 4 weeks prior to randomization, or anticipated need for live-attenuated vaccine vaccination during the study period.\n4. Known hypersensitivity to any component of SYS6010, or to humanized monoclonal antibody products; hypersensitivity or contraindication to irinotecan, paclitaxel, or docetaxel.\n5. Prior receipt of treatment with irinotecan-containing drugs or topoisomerase Ⅰ inhibitor-toxin antibody-drug conjugate (ADC) products.\n6. Body mass index (BMI) \\\u003C 16.0 kg\u002Fm\\^2 or body weight \\\u003C 40 kg.\n7. A history of any other active malignant tumor within 5 years (except for radically resected and non-recurrent basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, superficial bladder cancer, localized prostate cancer, carcinoma in situ of the cervix, or other carcinomas in situ).\n8. Presence of bleeding diathesis; active bleeding, hemoptysis, or a history of major bleeding within the past 6 months; imaging (CT or MRI) showing tumor invasion of major blood vessels, or the investigator judges that the tumor is highly likely to invade major blood vessels during the subsequent study period leading to fatal massive bleeding.\n9. Presence of any severe and\u002For uncontrolled disease prior to randomization, including but not limited to:\n\n   1. Myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] class ≥ Ⅱ), unstable angina pectoris, coronary angioplasty, or bypass surgery within 6 months prior to randomization;\n   2. Left ventricular ejection fraction (LVEF) \\\u003C 50% as indicated by echocardiography during screening;\n   3. Arterial\u002Fdeep venous thrombosis\u002Fcancer-associated thrombosis events (e.g., cerebrovascular accident including transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep venous thrombosis, pulmonary embolism, etc.) within 6 months prior to randomization;\n   4. Uncontrolled serous cavity effusions requiring repeated drainage (e.g., pleural effusion, ascites, pericardial effusion, etc.);\n   5. Uncontrolled hypertension (defined as systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg with medical management) or a history of hypertensive crisis\u002Fhypertensive encephalopathy;\n   6. Corrected QT interval using Fridericia's formula (QTcF) ≥ 450 ms in males and QTcF ≥ 470 ms in females; or a diagnosis of congenital long QT syndrome, and\u002For known concomitant use of drugs that prolong the QT interval;\n   7. Severe cardiac rhythm or conduction abnormalities (e.g., ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, etc.);\n   8. Clinically significant severe electrolyte abnormalities requiring medical treatment as judged by the investigator;\n   9. Poorly controlled diabetes mellitus (fasting blood glucose \\> 10.0 mmol\u002FL).\n10. Active viral hepatitis (positive HBsAg with HBV-DNA ≥ 10\\^4 cps\u002FmL or ≥ 2000 IU\u002FmL; positive HCV antibody with positive HCV viral titer); human immunodeficiency virus antibody (HIV-Ab) positive subjects; active syphilis infection (positive Treponema pallidum antibody with positive Rapid Plasma Reagin \\[RPR\\] or Toluidine Red Unheated Serum Test \\[TRUST\\]).\n11. A past history of interstitial lung disease (ILD)\u002Fnon-infectious pneumonia requiring glucocorticoid therapy, current ILD\u002Fnon-infectious pneumonia, or inability to rule out ILD\u002Fnon-infectious pneumonia by imaging examination during screening.\n12. A history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or abdominal abscess within 6 months prior to randomization; or obvious ulceration of the esophageal lesion, tumor invasion of adjacent tissues, or imaging evidence of a risk of tracheoesophageal fistula, and the investigator judges the subject to be unsuitable for anti-angiogenic drug therapy.\n13. A past or current history of mental disorders or epilepsy requiring treatment.\n14. Infection requiring systemic anti-infective therapy within 2 weeks prior to randomization (except for uncomplicated urinary tract infection or upper respiratory tract infection).\n15. Presence of clinically significant gastrointestinal diseases during screening, including bleeding, inflammation, obstruction, intractable vomiting (defined as ≥ 3 episodes of vomiting within 24 hours), and diarrhea of grade \\> 1.\n16. Ingestion of strong CYP3A4 inducers or inhibitors, or OATP1B1\u002FOATP1B3 inhibitors within 2 weeks prior to randomization, or anticipated need for the above drugs during the trial period.\n17. Failure of adverse reactions from prior chemotherapy, surgery, radiotherapy, or other anti-tumor therapies to resolve to ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0 or baseline levels (except for toxicities with no safety risk as judged by the investigator, such as alopecia).\n18. Presence of skin diseases requiring oral or intravenous drug therapy during screening, and the investigator judges the subject to be unsuitable for study drug administration.\n19. Other conditions that the investigator deems unsuitable for participation in this clinical trial.",{"count":403,"type":22},436,[74],"This study is a randomized, Controlled, Open-Label, Multicenter Phase Ⅲ Study of SYS6010 vs Investigator's Choice Single-Agent Chemotherapy in Locally Advanced\u002FMetastatic\u002FRecurrent ESCC Patients with Failure of At Least One Line of Systemic Therapy",[407],"Locally Advanced\u002FMetastatic\u002FRecurrent ESCC","2026-02-11",{"date":410,"type":33},"2026-02-18",{"date":412,"type":22},"2026-03-18",{"date":210,"type":22},{"name":39,"class":40},{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":155,"minAge":18,"maxAge":70,"enrollmentInfo":422,"targetDuration":4,"studyType":23,"phases":424,"briefSummary":425,"conditions":426,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":434,"locationsCount":41},"100624917","phase-1-phase-1ii-clinical-study-of-sys6043-in-the-treatment-of-advancedmetastatic-solid-tumors-100624917","NCT07415863","Phase 1\u002FII Clinical Study of SYS6043 in the Treatment of Advanced\u002FMetastatic Solid Tumors","Phase I\u002FII Dose-Escalation, PK Expansion and Cohort Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SYS6043 in Patients With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Aged 18 to 75 years inclusive (based on the date of signing the informed consent form). For Cohort 2 and Cohort 10, subjects over 75 years of age are eligible for enrollment.\n2. Histologically or cytologically confirmed advanced\u002Funresectable or metastatic solid tumors with disease recurrence or progression during or after standard systemic therapy, intolerance to standard therapy, or no available standard therapy.\n3. At least one extracranial measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). For participants with metastatic castration-resistant prostate cancer (mCRPC) with bone metastases only, eligibility for enrollment will be determined following a discussion and assessment with the sponsor's medical monitor on a case-by-case basis.\n4. Expected survival of the participant is ≥ 3 months.\n5. ECOG performance status of 0 or 1 with no deterioration in status identified within 28 days prior to enrollment. For Cohort 2 and Cohort 10, subjects with an ECOG performance status of 2 are eligible for enrollment.\n6. Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiography (ECHO) or radionuclide ventriculography (MUGA) within 28 days prior to enrollment.\n7. Adequate function of major organs meeting the following requirements within 7 days prior to enrollment:\n\n   1. Hematology (no receipt of whole blood, red blood cell or platelet transfusion, and no administration of hematopoietic stimulating factors \\[G-CSF or GM-CSF\\], erythropoietin \\[EPO\\] or thrombopoietin \\[TPO\\] for cytorection within 7 days prior to sample collection):Absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL;Platelet count (PLT) ≥ 100×10⁹\u002FL;Hemoglobin (HGB) ≥ 90 g\u002FL.\n   2. Blood biochemistry:Serum creatinine ≤ 1.5×upper limit of normal (ULN);Serum total bilirubin (TBIL) ≤ 1.5×ULN (may be relaxed to 3×ULN for participants with Gilbert's syndrome);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (≤ 5.0×ULN for participants with hepatocellular carcinoma or liver metastases);Serum albumin ≥ 30 g\u002FL.\n   3. Coagulation function:Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5×ULN (for participants not receiving anticoagulant therapy); for participants receiving anticoagulant therapy, indices shall be within the therapeutic target range with a stable dosage.\n8. Toxic reactions caused by any prior therapy have recovered to ≤ Grade 1 per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or baseline levels (except for alopecia, fatigue, peripheral neuropathy and other toxicities that the investigator deems to pose no safety risk to the participant).\n9. Sufficient washout period for prior anti-tumor therapies before the first study drug administration.\n10. Be willing to provide previously resected tumor samples or undergo a fresh tumor biopsy for the detection of B7-H3 expression levels and other biomarkers (if there are no contraindications).\n11. For female participants of childbearing potential, the serum pregnancy test result within 7 days prior to randomization must be negative. Male and female participants with reproductive potential must agree to adopt adequate contraceptive measures during the study period and for at least 7 months after the last administration of the study drug; during this period, female participants must not be breastfeeding, male participants must not freeze or donate sperm, and female participants must not donate or retrieve oocytes for personal use.\n12. Have a full understanding of this clinical trial and voluntarily sign a written informed consent form\n13. Advanced or metastatic solid tumors with failure of standard systemic therapy\n\nExclusion Criteria:\n\n1. Prior receipt of B7-H3-targeted therapy.\n2. Prior receipt of irinotecan, topotecan, any other topoisomerase I inhibitors (including investigational TOP1 inhibitors), or topoisomerase inhibitor antibody-drug conjugates (e.g., trastuzumab deruxtecan). This criterion applies only to the Phase I PK expansion and Phase II cohort expansion stages.\n3. A history of symptomatic congestive heart failure (CHF) (New York Heart Association \\[NYHA\\] Class II-IV) or severe cardiac arrhythmias requiring treatment.\n4. A history of myocardial infarction or unstable angina within 6 months prior to enrollment.\n5. A prolonged corrected mean QT interval (QTcF) using the Fredericia formula of \\>470 milliseconds (ms) on three 12-lead electrocardiogram (ECG) assessments, for both male and female participants.\n6. Inability or unwillingness to discontinue concomitant medications known to prolong the QT interval.\n7. A history of interstitial lung disease (ILD)\u002Fnon-infectious pneumonia requiring glucocorticoid therapy, current ILD\u002Fnon-infectious pneumonia, or suspected such disease on imaging during screening.\n8. A history of underlying pulmonary disease, including but not limited to pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, and other clinically significant pulmonary impairment within 3 months prior to the start of study treatment, or the need for supplemental oxygen.\n9. Any autoimmune, connective tissue, or inflammatory disease involving the lungs that is documented or suspected during screening (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.).\n10. Uncontrolled infection requiring intravenous antibiotics, antiviral agents, or antifungal agents.\n11. Known human immunodeficiency virus (HIV) infection, or currently active syphilis infection (i.e., positive Treponema pallidum antibody \\[RPR or TRUST\\] or syphilis requiring systemic therapy).\n12. Participants with active viral hepatitis (positive hepatitis B surface antigen \\[HBsAg\\] and\u002For positive hepatitis B core antibody \\[anti-HBc\\] with HBV DNA ≥1000 copies\u002FmL or 2000 IU\u002FmL; positive hepatitis C virus \\[HCV\\] with HCV RNA above the lower limit of quantification \\[LLOQ\\] of the assay).\n13. Lactating women (women willing to temporarily discontinue breastfeeding are also excluded), or women confirmed to be pregnant by pregnancy test within 7 days prior to enrollment.\n14. Presence of spinal cord compression, or clinically active brain or meningeal metastases. Participants with central nervous system (CNS) metastases are eligible if: they have received prior CNS-directed therapy and have had radiological and neurological stability for at least 4 weeks before the first dose (i.e., no new or enlarging metastatic lesions on imaging, no requirement for corticosteroid therapy or maintenance of a stable or tapering dose of corticosteroids \\[equivalent to ≤10 mg\u002Fday prednisone\\], and no symptoms); or they have untreated asymptomatic CNS metastases that the investigator assesses as not requiring immediate treatment.\n15. A history of multiple primary malignant neoplasms within 3 years prior to enrollment, except for: adequately resected non-melanoma skin cancer (e.g., resected basal or squamous cell skin cancer); in situ disease treated with curative intent (e.g., cervical or breast carcinoma in situ); and other solid tumors treated with curative intent (e.g., superficial bladder cancer).\n16. A history of substance abuse, or any other medical condition that the investigator deems may increase the safety risk to the participant or interfere with the participant's participation in or evaluation of the clinical study.\n17. Receipt of strong CYP3A4 inhibitors or inducers within 14 days prior to the first dose of the study drug, or the need for continued use of such medications during the study period.\n18. Known hypersensitivity to the active ingredient or excipients of the study drug.\n19. Presence of pleural, pericardial, or peritoneal effusion with clinical symptoms or requiring repeated drainage.\n20. Any other reason that the investigator deems the participant unsuitable for enrollment in the study",{"count":423,"type":22},820,[25,52],"Phase I\u002FII Clinical Study of SYS6043 in the Treatment of Advanced\u002FMetastatic Solid Tumors This study is a first-in-human phase I\u002FII, multicenter, open-label, dose-escalation trial with PK expansion and cohort expansion, designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary anti-tumor efficacy of SYS6043 (a B7-H3-targeted antibody-drug conjugate) in patients with advanced\u002Fmetastatic solid tumors. It consists of three parts: dose escalation, PK expansion and cohort expansion.",[427],"Advanced\u002FMetastatic Solid Tumors","2026-02-10",{"date":430,"type":33},"2026-02-17",{"date":432,"type":33},"2024-12-30",{"date":351,"type":22},{"name":39,"class":40},{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":70,"enrollmentInfo":442,"targetDuration":4,"studyType":23,"phases":444,"briefSummary":445,"conditions":446,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":4},"100624200","phase-3-a-phase-iii-study-of-sys6010-versus-chemotherapy-in-her2-negative-egfr-positive-recurrent-or-metastatic-breast-cancer-100624200","NCT07406542","A Phase III Study of SYS6010 Versus Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast Cancer","A Randomized, Open-Label, Parallel-Control, Multicenter Phase III Clinical Study of SYS6010 Versus Investigator's Choice Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast Cancer","Inclusion Criteria:\n\n1. Age 18 to 75 years inclusive, no gender restrictions.\n2. Histopathologically confirmed breast cancer at an unresectable recurrent or metastatic stage, requiring: a) HER2-negative; b) EGFR-positive expression.\n3. Subjects must have received 1 to 2 lines of systemic chemotherapy regimens during the unresectable advanced or metastatic stage.\n4. At least one measurable lesion confirmed by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Brain metastases are evaluated only as non-target lesions. Patients with skin lesions only are ineligible.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n6. Expected survival ≥3 months.\n7. Adequate major organ function status within 7 days prior to first study drug administration.\n8. Subjects must agree to use effective contraception from informed consent signing until the protocol-specified time after last dose; females must not be lactating and males must refrain from sperm donation during this period. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first study drug administration. Female subjects must not be lactating.\n9. Voluntarily participate in this clinical study, understand the research procedures, and be able to sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Presence of cancerous meningitis, spinal cord compression, or active central nervous system metastases. Active central nervous system metastases are specifically defined as untreated, symptomatic, or requiring corticosteroids\u002Fanticonvulsants to control related symptoms; except for cases stable for at least one month following treatment for brain metastases and having discontinued corticosteroids\u002Fanticonvulsants for \\>2 weeks.\n2. Poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention (including clinically significant recurrence requiring additional intervention within 2 weeks prior to enrollment).\n3. History of other malignancies within 3 years prior to first use of study drug, except for: cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, papillary thyroid carcinoma, and cervical carcinoma in situ\n4. Prior treatment with topoisomerase I inhibitors (including ADCs)\n5. Prior treatment with EGFR-targeted ADCs or monoclonal antibodies\n6. Known hypersensitivity to any component of SYS6010 or to humanized monoclonal antibody products\n7. Adverse events from prior antitumor therapy not recovered to ≤ Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 (excluding Grade 2 alopecia, asymptomatic laboratory abnormalities, etc., deemed safe by the investigator).\n8. Patients with inadequate washout periods for prior medications or treatments, as specified in the protocol, prior to the first administration of the study drug. 9. History of severe cardiovascular or cerebrovascular disease.\n\n10\\. Clinically significant pulmonary impairment due to pulmonary complications. 11. History of interstitial lung disease (ILD)\u002Fnon-infectious pneumonia requiring glucocorticoid therapy, current ILD\u002Fnon-infectious pneumonia, or inability to exclude ILD\u002Fnon-infectious pneumonia based on imaging at screening.\n\n12\\. Subjects with active inflammatory bowel disease, gastrointestinal obstruction, active peptic ulcer, recent (within 4 weeks) gastrointestinal bleeding, gastrointestinal perforation, or severe gastrointestinal conditions such as abdominal abscess (excluding those with a history of resolved conditions).\n\n13\\. Severe infection within 4 weeks prior to first use of the investigational drug, including but not limited to: bacteremia requiring hospitalization, severe pneumonia, active tuberculosis infection, or requiring oral or intravenous antibiotic, antifungal, or antiviral therapy due to infection within 2 weeks prior to first dosing (except for prophylactic use).\n\n14\\. Uncontrolled diabetes (fasting blood glucose ≥10 mmol\u002FL and\u002For HbA1c ≥8%). 15. Active hepatitis B, active hepatitis C virus infection, or active syphilis infection.\n\n16\\. Human immunodeficiency virus (HIV) infection diagnosed as acquired immunodeficiency syndrome (AIDS).\n\n17.Other conditions deemed unsuitable for participation in this clinical trial by the investigator (e.g., uncontrolled psychiatric disorders or anticipated poor compliance).",{"count":443,"type":22},400,[74],"This study is a multicenter, randomized, open-label, parallel-control Phase III clinical trial enrolling patients with unresectable HER2-negative, EGFR-positive recurrent\u002Fmetastatic breast cancer who have previously failed first- or second-line chemotherapy. It aims to compare the efficacy and safety of SYS6010 monotherapy versus investigator-selected chemotherapy.The study plans to enroll approximately 400 subjects, randomly assigned in a 1:1 ratio to the treatment arm and control arm(Investigator's choice of standard chemotherapy regimen, including eribulin, capecitabine, gemcitabine, or vinorelbine).",[447],"Recurrent or Metastatic Breast Cancer","2026-02-05",{"date":450,"type":33},"2026-02-12",{"date":452,"type":22},"2026-04-01",{"date":454,"type":22},"2030-04-01",{"name":39,"class":40},{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":70,"enrollmentInfo":463,"targetDuration":4,"studyType":23,"phases":465,"briefSummary":466,"conditions":467,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":41},"100612515","phase-2-sys6010-combined-with-enlonstobart-in-recurrent-or-metastatic-head-and-neck-squamous-cell-carcinoma-100612515","NCT07254585","SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma","An Open-label, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of SYS6010 Combined With Enlonstobart in the Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Aged 18-75 (inclusive) years old, male or females;\n2. Participants with histologically confirmed recurrent or metastatic head and neck squamous cell carcinoma who are not suitable for radical surgery or concurrent chemoradiotherapy.\n3. For SYS6010 combined with Enlonstobart group: Participants who have not previously received systemic anti-tumor treatment. If participants have received neoadjuvant or adjuvant therapy (or combination targeted therapy), they are eligible if disease progression occurs at least 6 months after the last administration.\n4. For Enlonstobart group: Participants who have not previously received immunotherapy are included. For participants who have not previously undergone systemic antitumor treatment, baseline PD-L1 positivity (CPS≥1) must be confirmed by the central laboratory; for participants who have previously received systemic antitumor treatment, there is no restriction on baseline PD-L1 expression.\n5. At least one measurable lesion confirmed by CT or MRI scan according to RECIST v1.1 criteria\n6. ECOG performance status of 0-1;\n7. Life expectancy ≥ 3 months;\n8. Major organ function must meet the criteria within 7 days prior to the first dose of the study intervention\n9. Women of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose. Participants must agree to use effective contraception from the time of signing the informed consent form until 7 months after the last dose; during this period, women should not be breastfeeding, and men should avoid donating sperm;\n10. Voluntarily participate in this clinical study, understand the study procedures, and be able to sign a written informed consent form.\n\nExclusion Criteria:\n\n1. The primary sites include the nasopharynx, salivary glands, sinuses, skin, or squamous cell carcinoma of unknown primary origin; Histologically or cytologically confirmed combined neuroendocrine carcinoma, mesenchymal tumors or carcinosarcoma.\n2. Patients with meningeal metastasis, brainstem metastasis, spinal cord metastasis and\u002For compression, or active CNS metastasis. Patients with supratentorial and\u002For cerebellar metastasis (i.e., without mesencephalon, pons, or medulla involvement) who have received local treatment, have achieved stability for at least 2 weeks prior to the first dose of the study intervention (imaging shows no new brain metastasis or enlargement of existing brain metastasis, and all neurologic symptoms have stabilized or returned to normal), and do not require corticosteroid therapy or are receiving prednisone at a daily dose of ≤10 mg or equivalent doses of other corticosteroids, can participate in the study;\n3. Patients with a history of other malignant tumors within 3 years prior to the first dose of the study intervention, except for the following conditions: cured skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, and cervical carcinoma in situ, etc.;\n4. Patients who are known to be allergic to any component of SYS6010, Enlonstobart or to humanized monoclonal antibody products;\n5. AEs caused by prior anti-tumor treatment have not recovered to ≤ Grade 1 (excluding Grade 2 alopecia, peripheral neurotoxicity, and other toxicities judged by the investigator to have no safety risk) according to NCI-CTCAE v5.0;\n6. Previously received systemic anti-tumor therapy for locally advanced or metastatic non-squamous NSCLC other than EGFR TKI; patients who have previously received adjuvant\u002Fneoadjuvant chemotherapy and experienced disease progression more than 12 months after the end of treatment are allowed to be included;\n7. Patients who have not met the corresponding washout period requirements for the medications or treatments should be excluded:\n8. History of severe cardiovascular or cerebrovascular disease within 6 months prior to the first dose of the study intervention\n9. Imaging examination suggests tumor invasion of the cervical, thoracic, and abdominal great vessels;\n10. Patients who have a history of ILD\u002Fnon-infectious pneumonitis treated with corticosteroids in the past, currently have ILD\u002Fnon-infectious pneumonitis, for whom imaging examinations at screening cannot rule out ILD\u002Fnon-infectious pneumonitis, or whose pulmonary function test indicates severe ventilatory dysfunction and\u002For decreased diffusion capacity;\n11. Presence of severe infections within 4 weeks prior to the first dose of the study intervention, including but not limited to bacteraemia requiring hospitalisation, severe pneumonia, active pulmonary tuberculosis infection, etc.; presence of active infections requiring systemic antibiotics within 2 weeks prior to the first dose of the study intervention;\n12. Previous interruption of EGFR-targeted therapy for ≥1 month or permanent discontinuation due to skin toxicity, or currently have skin diseases requiring oral or intravenous medication;\n13. Participants with active autoimmune diseases or a history of autoimmune diseases (such as ulcerative colitis or Crohn's disease) are excluded, but participants with the following conditions are allowed to proceed to further enrollment screening: well-controlled type 1 diabetes and hypothyroidism that is well-controlled with only hormone replacement therapy.\n14. Pleural effusion or pericardial effusion requiring clinical intervention within 2 weeks prior to the first dose;\n15. Active HBV or HCV infection (hepatitis B surface antigen and\u002For hepatitis B core antibody positive and HBV DNA copies ≥ 1×104 copies\u002FmL or ≥ 2000 IU\u002FmL, HCV antibody positive and HCV RNA above the lower limit of detection of the analytical procedure). Note: For HBsAg-positive patients, it is recommended to start antiviral therapy before the first dose of the study intervention, nucleoside analogues are recommended, such as entecavir, tenofovir disoproxil;\n16. History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases), history of allogeneic stem cell or organ transplant;\n17. Other conditions that the investigator deems unsuitable for participation in this clinical study (such as mental disorders, macular cystoid oedema, severe corneal disorders, uncontrolled or poorly controlled hypertension and diabetes mellitus)",{"count":464,"type":22},70,[52],"This study is a n open-label, multi-center, phase II study to evaluate the efficacy and safety of SYS6010 combined with Enlonstobart in the recurrent or metastatic head and neck squamous cell carcinoma.",[77],"2026-01-23",{"date":470,"type":33},"2026-01-26",{"date":472,"type":33},"2025-12-18",{"date":474,"type":22},"2027-12-31",{"name":39,"class":40},{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":483,"enrollmentInfo":484,"targetDuration":4,"studyType":23,"phases":486,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":494,"leadSponsor":495,"locationsCount":4},"100621740","phase-2-sys6002-vs-padcev-in-patients-with-advanced-urothelial-carcinoma-100621740","NCT07374549","SYS6002 vs PADCEV in Patients With Advanced Urothelial Carcinoma","A Randomized, Open-Label, Controlled, Multicenter Phase 2 Trial of SYS6002 Versus PADCEV in Patients With Advanced Urothelial Carcinoma","Inclusion Criteria:\n\n* 1\\. Patients aged 18-80 years (inclusive);\n* 2\\. Pathologically confirmed patients with advanced urothelial carcinoma who have received a platinum-based chemotherapy with anti-PD-(L)1 agent. For those who received these therapies in the adjuvant or neoadjuvant setting, disease progression must have occurred during treatment or within 12 months of treatment completion;\n* 3 An archival tumor tissue sample or a fresh tissue sample should be provided;\n* 4 Subjects must have measurable disease according to RECIST (version 1.1);\n* 5 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n* 6 Life expectancy of ≥ 3 months;\n* 7 Major organ function must meet the relevant laboratory test standards for hematology, renal function, liver function, and coagulation within 7 days prior to treatment;\n* 8Sexually active fertile subjects must agree to use methods of contraception during the study and at least 7 months after termination of study therapy and have a negative urine or serum pregnancy test within 7 days prior to randomization;\n* 9.Willing to participate in the study, understand the study procedures, and sign a written informed consent form.\n\nExclusion Criteria:\n\n* 1.Active central nervous system metastases or leptomeningeal metastasis;\n* 2.Adverse events from prior anti-tumor therapy not recovered to ≤ Grade 1 (unless the investigator deems there is no safety risk)；\n* 3.Any serious and\u002For uncontrolled concurrent illness that may interfere with patient's participation in the study:\n\n  1. Participants with a history of severe cardiovascular disease within 6 months prior to randomization, including but not limited to:\n\n     Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia and third-degree atrioventricular block requiring clinical intervention; corrected QT interval \\> 480 ms by Fridericia method (Fridericia formula: QTcF = QT\u002FRR\\^0.33, RR = 60\u002Fheart rate); With history of myocardial infarction, unstable angina pectoris, angioplasty and coronary artery bypass surgery; New York Heart Association (NYHA) classification Grade III and above heart failure, and left ventricular ejection fraction (LVEF) \\\u003C 50% in the tests and examinations during the screening period; cerebrovascular accidents; pulmonary embolisms;\n  2. Other clinically significant diseases:\n\nHbA1c \\> 8%; Participants with active keratitis and corneal ulcer, or fundus lesions with a risk of blindness; Grade ≥2 neuropathy prior to randomization; Severe infection within 4 weeks prior to randomization; active infection requiring systemic antibiotics, antiviral, or antifungal therapy within 2 weeks prior to randomization; Active HBV or HCV infection; History of immunodeficiency (HIV-positive, acquired or congenital immunodeficiency, etc.), or organ transplantation; History of another malignancy within 3 years prior to randomization; History of interstitial lung disease (ILD) \u002F non-infectious pneumonia, or current ILD\u002Fnon-infectious pneumonia, or imaging findings at screening that cannot rule out these conditions, except for those who are determined to be risk-free after discussion between the investigator and the sponsor; Pleural effusion, ascites or pericardial effusion with symptoms or requiring puncture or drainage within 2 weeks prior to randomization;\n\n* 4.Use of other unmarketed clinical investigational drugs or treatments, chemotherapy, radiotherapy targeted therapy within 4 weeks prior to randomization; use of traditional Chinese medicine with anticancer indication, oral fluoropyrimidine drugs, small molecule targeted drug within 2 weeks prior to randomization; use of palliative radiation or local therapy within 2 weeks prior to randomization;with major surgery within 4 weeks prior to randomization;\n* 5.Allergy to any component of SYS6002, or humanized monoclonal antibodies; investigator-determined ineligibility for enfortumab vedotin therapy.\n* 6\\. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.","80 Years",{"count":485,"type":22},100,[52],"This study is a randomized, open-label, controlled, multicenter phase II clinical trial, which aims to evaluate the safety and efficacy of SYS6002 versus enfortumab vedotin in the treatment of participants with advanced urothelial carcinoma.\n\nThis study has not yet been submitted for ethical review. The current registration is a pre-registration. Recruitment will be initiated only after formal approval is obtained from the relevant Ethics Committee or Institutional Review Board.",[489],"Advanced Urothelial Carcinoma","2026-01-21",{"date":492,"type":33},"2026-01-29",{"date":370,"type":22},{"date":84,"type":22},{"name":39,"class":40},{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":16,"sex":17,"minAge":503,"maxAge":4,"enrollmentInfo":504,"targetDuration":4,"studyType":23,"phases":506,"briefSummary":507,"conditions":508,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":4},"100620210","phase-2-immunogenicity-and-safety-of-sys6017-in-the-participants-aged-40-years-and-above-100620210","NCT07354659","Immunogenicity and Safety of SYS6017 in the Participants Aged 40 Years and Above","A Randomized, Blinded, Placebo- and Active-Controlled, Adaptive Phase 2 Study to Evaluate the Immunogenicity and Safety of SYS6017 (a Herpes Zoster mRNA Vaccine) in Healthy Participants Aged 40 Years and Above","Inclusion Criteria:\n\n* 1\\. Individuals aged 40 years or older;\n* 2\\. Able to understand the study procedures, comply with the protocol requirements to attend all the scheduled visits, voluntarily consent to participate in the study, and sign the informed consent form;\n* 3\\. Is physically eligible at the discretion of investigators based on medical history inquiry and physical examination; For participants with chronic underlying diseases (e.g., diabetes mellitus, hypertension, hyperlipidemia and other chronic conditions), they may be enrolled if their conditions have been well controlled within 3 months prior to enrollment in this study (i.e., additional medical interventions or major adjustments to treatments are not required);\n* 4\\. For female participants of childbearing potential: No sexual activity or effective contraceptive methods were used within one menstrual cycle before enrollment; No pregnancy plans and agree to adopt effective contraceptive methods within 8 months after enrollment.\n\nExclusion Criteria:\n\n* 1\\. History of zoster;\n* 2\\. History of vaccination with varicella vaccine or zoster vaccine (including investigational vaccine);\n* 3\\. Axillary temperature ≥ 37.1℃ on the day of enrollment or within 24 h before enrollment;\n* 4\\. History of allergy to any component of the investigational vaccine; or history of severe allergic reactions to vaccines or medications (including but not limited to anaphylaxis, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura, or Arthus reaction);\n* 5\\. History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or any condition that could increases the risk of myocarditis or pericarditis\n* 6\\. History of demyelinating diseases, including but not limited to Guillain-Barré syndrome, multiple sclerosis, ophthalmoneuromyelitis, acute disseminated encephalomyelitis, etc.;\n* 7\\. Current epilepsy or convulsion, severe neurological or psychiatric disorders;\n* 8\\. Have contraindications to intramuscular injection, e.g., diagnosed thrombocytopenia, any coagulation disorders, or ongoing treatment with anticoagulants, etc.;\n* 9\\. Active malignant tumor, malignant tumor without adequate treatment, malignant tumor with a potential risk of recurrence during the study;\n* 10\\. Active, unstable, severe or uncontrolled cardiovascular and cerebrovascular diseases, thrombotic diseases, blood and lymphatic system diseases, liver and kidney diseases, respiratory diseases, metabolic diseases, musculoskeletal diseases, autoimmune diseases, etc;\n* 11\\. History of diagnosed immunocompromise or immunosuppression, congenital or functional asplenia, or splenectomy before enrollment;\n* 12\\. Long-term (defined as more than 14 consecutive days) systemic use of immunosuppressants, immunostimulants, or other immunomodulatory drugs (e.g., corticosteroids at a dose of ≥ 20 mg\u002Fday prednisone or equivalent) within 6 months prior to enrollment; however, inhaled and topical corticosteroids are permitted; or planned administration of the aforementioned agents during the study period;\n* 13\\. Administration of whole blood, plasma, serum, immunoglobulin, or monoclonal antibodies within 3 months prior to enrollment, or planned administration of the aforementioned products during the study period;\n* 14\\. Blood donation or blood loss ≥ 450 mL within one month before enrollment, or planning to donate blood during the study;\n* 15\\. Vaccination with any other vaccines within 30 days prior to enrollment, or planned vaccination with any other vaccines within 30 days after the last dose of the study vaccine;\n* 16\\. Current participation in or planned participation in other clinical trials during the study period;\n* 17\\. For female participants of childbearing potential: positive pregnancy test result prior to enrollment, current pregnancy or lactation, or planned pregnancy within 8 months after enrollment;\n* 18\\. Unable to comply with the study procedures and requirements, or presence of other conditions that make the participant inappropriate for this clinical trial, as judged by the investigators.","40 Years",{"count":505,"type":22},800,[52],"Herpes zoster is caused by the reactivation of latent varicella-zoster virus (VZV) which stays in latency after its primary infection. Immunosenescence contributes significantly to elevating morbidity associated with aging. Vaccination plays a key role in reducing the disease burden of zoster and the associated complications. We are conducting a study entitled \"A Randomized, Blinded, Placebo- and Active-Controlled, Adaptive Phase 2 Clinical Trial to Evaluate the Immunogenicity and Safety of SYS6017 (a Herpes Zoster mRNA Vaccine) in Healthy Participants Aged 40 Years and Above\".",[509],"Herpes Zoster","2026-01-12",{"date":490,"type":33},{"date":513,"type":22},"2026-01-10",{"date":515,"type":22},"2027-05-31",{"name":39,"class":40},{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":4,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":70,"enrollmentInfo":524,"targetDuration":4,"studyType":23,"phases":526,"briefSummary":527,"conditions":528,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":533,"leadSponsor":535,"locationsCount":4},"100612663","phase-2-a-study-of-sys6010-combined-with-osimertinib-versus-osimertinib-alone-as-neoadjuvant-therapy-for-patients-with-egfr-mutation-positive-resectable-non-squamous-non-small-cell-lung-cancer-100612663","NCT07256509","A Study of SYS6010 Combined With Osimertinib Versus Osimertinib Alone as Neoadjuvant Therapy for Patients With EGFR Mutation-positive Resectable Non-squamous Non-small Cell Lung Cancer","A Phase II Study to Evaluate the Safety and Efficacy of SYS6010 Combined With Osimertinib Versus Osimertinib as Neoadjuvant Therapy in Participants With Resectable Stage II-IIIB Non-squamous Non-small Cell Lung Cancer With EGFR Mutation Positive","Inclusion Criteria:\n\n1. Able to understand and voluntarily sign the written informed consent form (ICF);\n2. Age 18-75 years, regardless of sex;\n3. Histologically or cytologically confirmed non-squamous non-small cell lung cancer, staged as resectable or potentially resectable Stage II-IIIB disease according to the International Association for the Study of Lung Cancer (IASLC) 8th Edition TNM staging criteria;\n4. Must be eligible for complete surgical resection of the primary tumor;\n5. Nodal status must be evaluated by whole-body FDG-PET and contrast-enhanced CT;\n6. Confirmed presence of an EGFR-sensitizing mutation (exon 19 deletion or exon 21 L858R mutation, co-mutation with other EGFR sites is allowed), as tested by a central laboratory or local testing facility;\n7. No prior systemic anti-tumor therapy (including chemotherapy, biotherapy, targeted therapy, immunotherapy);\n8. At least one measurable lesion at baseline as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;\n9. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;\n10. Life expectancy ≥6 months;\n11. Adequate major organ and bone marrow function;\n12. Women or men of childbearing potential must use highly effective contraception.\n\n1\\. Able to understand and voluntarily sign the written informed consent form (ICF); 2. Age 18-75 years, regardless of sex; 3. Histologically or cytologically confirmed non-squamous non-small cell lung cancer, staged as resectable or potentially resectable Stage II-IIIB disease according to the International Association for the Study of Lung Cancer (IASLC) 8th Edition TNM staging criteria; 4. Must be eligible for complete surgical resection of the primary tumor; 5. Nodal status must be evaluated by whole-body FDG-PET and contrast-enhanced CT; 6. Confirmed presence of an EGFR-sensitizing mutation (exon 19 deletion or exon 21 L858R mutation, co-mutation with other EGFR sites is allowed), as tested by a central laboratory or local testing facility; 7. No prior systemic anti-tumor therapy (including chemotherapy, biotherapy, targeted therapy, immunotherapy); 8. At least one measurable lesion at baseline as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; 9. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; 10. Life expectancy ≥6 months; 11. Adequate major organ and bone marrow function; 12. Women or men of childbearing potential must use highly effective contraception.\n\nExclusion Criteria:\n\n1. Diagnosis of Stage I, Stage IIIB with N3, and Stage IIIC, IVA, and IVB non-small cell lung cancer;\n2. Multiple primary malignancies (refer to exclusion criterion #8 for synchronous primary lung cancer) OR a mixed histology of SCLC and NSCLC;\n3. T4 stage lung cancer due to invasion of the great vessels, carina, trachea, esophagus, heart, or vertebral body; and\u002For bulky N2 disease;\n4. Eligible only for segmentectomy or wedge resection;\n5. Receipt of Chinese patent medicine preparations indicated for the treatment of lung cancer within 1 week before randomization;\n6. Major surgery or severe traumatic injury within 4 weeks before the first study treatment, or expected to undergo major surgery during the study period;\n7. History of other primary malignant tumor (including any known or suspected concurrent primary lung cancer);\n8. History of autoimmune disease, immunodeficiency, or organ transplant (except for corneal transplant);\n9. Refractory nausea, vomiting, chronic gastrointestinal disease, inability to swallow drugs orally;\n10. Evidence of severe or uncontrolled medical conditions (including uncontrolled hypertension, diabetes mellitus, etc,);\n11. Active or prior history of interstitial lung disease (ILD)\u002Fpneumonitis;\n12. Expected to receive live vaccine therapy within 30 days after randomization;\n13. History of a definite neurological or mental disorder; known allergy, hypersensitivity, or intolerance to the study drugs or any of their excipients;\n14. Pregnant or lactating women;",{"count":525,"type":22},120,[52],"To evaluate the safety and efficacy of SYS6010 combined with osimertinib as neoadjuvant therapy for patients with resectable EGFR mutation non-squamous non-small cell lung cancer.",[283],"2025-11-30",{"date":531,"type":33},"2025-12-05",{"date":529,"type":22},{"date":534,"type":22},"2032-06-30",{"name":39,"class":40},""]