[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:solid-tumors":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,123,0,25,[9,50,72,94,119,137,165,193,213,233,252,275,296,314,331,363,393,414,466,500,529,575,600,648,673],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100632080","autologous-b7-h3-chimeric-antigen-receptor-t-cells-in-previously-treated-extensive-stage-small-cell-lung-cancer-with-recurrent-or-refractory-disease-100632080",false,"NCT07509034","Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Cell Lung Cancer With Recurrent or Refractory Disease","A Phase I Study to Assess the Safety and Antitumor Activity of Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Cell Lung Cancer With Recurrent or Refractory Disease","* INCLUSION CRITERIA:\n* Age \\>=18 years old.\n* Histologically confirmed small cell lung cancer (SCLC) or extrapulmonary neuroendocrine cancers (EP-NEC) that has recurred following or is refractory to first-line therapy. Note: small cell cancers of non-lung primary sites are also eligible.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2.\n* Pulse oximetry \\>= 90% on room air.\n* Aspartate Transferase (AST) \\\u003C 3 X institutional upper limit of normal (ULN). Note: in case of liver metastases \\\u003C= 5 X ULN is acceptable.\n* Alanine Aminotransferase (ALT) \\\u003C 3 X institutional ULN. Note: in case of liver metastases \\\u003C= 5 X ULN is acceptable.\n* Total bilirubin \\\u003C=2 X institutional ULN.\n* Creatinine \\\u003C=1.5 X institutional ULN OR creatinine clearance (CrCl) \\>= 50 mL\u002Fmin\u002F1.73m\\^2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] formula or calculated eGFR provided by a laboratory).\n* Absolute Neutrophil Count (ANC) \\>= 750\u002FmcL.\n* Platelet count \\>= 75,000\u002FmcL.\n* An absolute lymphocyte count (ALC) \\>=300\u002FmcL and CD3+ cell count \\>=150\u002FmcL.\n* Normal cardiac ejection fraction as defined by \\>= 45% by echocardiogram (ECHO) at screening.\n* At least 1 measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 that has not been previously irradiated.\n* Recovered from acute toxic effects of all prior cancer therapy to Grade \\\u003C2 per Common Terminology Criteria for Adverse Events (CTCAE) v.6.0 at least one week before apheresis excluding the parameters for ANC and ALC mentioned above.\n* The following criteria must be met prior to apheresis:\n\n  * Chemotherapy and biologic\u002Ftargeted agents:\n\n    * \\>=14 days since the last dose of standard myelosuppressive chemotherapy.\n    * \\>= 7 days since the completion of biologic agent, targeted agent, or tyrosine kinase inhibitor therapy.\n    * \\>= 3 weeks or 5 half-lives (whichever is shorter) since prior therapy with a monoclonal antibody.\n  * Radiotherapy:\n\n    * \\>= 1 week since the last radiotherapy session.\n    * No washout period required for palliative radiation to non-target lesions.\n    * \\>= 3 weeks since hepatic radiation, chemoembolization, and\u002For radiofrequency ablation.\n  * Steroids and immunosuppressive therapy:\n\n    * Corticosteroids: \\>= 2 weeks since the therapeutic doses (\\> 0.5 mg\u002Fkg\u002Fday prednisone or equivalent). Note: Inhaled or topical steroids are not exclusionary.\n    * Physiologic replacement doses (up to 5 mg\u002Fday prednisone equivalent) are allowed and can be adjusted based on participant's BMI if warranted.\n    * \\>= 2 weeks since the other immunosuppressive medication (e.g., calcineurin inhibitors, methotrexate, rapamycin, thalidomide, etc.).\n  * Anti-PD-1 and any investigational therapies:\n\n    * \\>= 2 weeks since Anti-PD-1 monoclonal antibody therapy.\n    * \\>= 2 weeks or 5 half-lives of the investigational product (whichever is shorter) since any investigational treatment or clinical trial participation.\n  * Other criteria:\n\n    * 72 hours since small molecule tyrosine kinase inhibitors (e.g., EGFR inhibitors), PARP inhibitors, or KRAS G12C inhibitors.\n* Individuals of childbearing potential (IOCBP) must agree to use highly effective contraception (hormonal, intrauterine device \\[IUD\\], abstinence, surgical sterilization) at the study entry and up to 12 months after the last dose of combined chemotherapy.\n\nNote: IOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.\n\n* Individuals able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and up to 7 months after the last dose of study drugs. We also will recommend individuals able to father a child with partners of childbearing potential ask partners to be on highly effective birth control (hormonal, IUD, surgical sterilization). Individuals able to father a child must not freeze or donate sperm within the same period.\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last dose of the study drug(s).\n* Ability of the participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* History of anaphylactic reactions attributed to anti-B7-H3 antibodies or compounds of similar chemical or biologic composition to autologous B7-H3 CAR T cells, cyclophosphamide, fludarabine, or other agents used in this study.\n* Infection exposure with the human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) as defined below:\n\n  * Positive serology for HIV.\n  * Active HBV infection as demonstrated by test for hepatitis B surface antigen (HBsAg).\n  * Positive serology for HCV.\n* Prior gene therapy using an integrating vector (except for autologous B7-H3 CAR T cells retreatment).\n* History of any previous allogeneic hematopoietic stem cell transplant.\n* Presence of fungal, bacterial, viral, or other infection is permitted if responding to active treatment.\n* Central Nervous System (CNS) disorder such as cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement that may impair the ability to evaluate neurotoxicity.\n* Pregnancy confirmed with beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test in IOCBP at screening.\n* Uncontrolled intercurrent illness or medical condition(s) evaluated by medical history, physical exam, electrocardiogram (ECG) or situations that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study.","ALL","18 Years","120 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","Background:\n\nSmall cell lung cancer (SCLC) is the deadliest form of lung cancer. Extrapulmonary neuroendocrine cancer (EPNEC) is a similar type of cancer that develops anywhere other than the lungs. EPNEC is also deadly. B7-H3 is a protein often found in SCLC and EPNEC tumor cells. Researchers can modify a person s own T cells, or immune cells, to target B7-H3. When these modified T cells are returned to the body-a treatment called B7-H3 chimeric antigen receptor (CAR) T cell therapy-they may help kill cancer cells.\n\nObjective:\n\nTo test B7-H3 CAR T cell therapy in people with SCLC or EPNEC.\n\nEligibility:\n\nPeople aged 18 years and older with SCLC or EPNEC that either did not respond or returned after treatment.\n\nDesign:\n\nParticipants will be screened. They will have blood tests and tests of their heart function. They will have imaging scans.\n\nParticipants will undergo apheresis: Blood will be taken from the body through a needle. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different needle. The collected T cells will be altered to make them attack cells with B7-H3.\n\nParticipants will be in the hospital for at least 15 days. They will receive chemotherapy drugs to prepare their body for the treatment. These drugs will be given through a tube attached to a needle inserted into a vein.\n\nThe modified T cells will be infused through a vein. Participants will remain in the hospital until they are well enough to go home.\n\nFollow-up visits will continue for 15 years....",[28,29,30,31],"Extensive-Stage Small Cell Lung Cancer","Extrapulmonary Neuroendocrine Carcinoma","Recurrent or Refractory","Solid Tumors",[33,34,35,36],"B7-H3","CAR-T","Phase I","Immunotherapy","NOT_YET_RECRUITING","2026-08-20",{"date":40,"type":41},"2026-08-21","ACTUAL",{"date":43,"type":22},"2026-08-26",{"date":45,"type":22},"2031-01-30",{"name":47,"class":48},"National Cancer Institute (NCI)","NIH",1,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":55,"conditions":61,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100584126","phase-1-a-study-of-zl-1310-in-participants-with-selected-solid-tumors-100584126","NCT06885281","A Study of ZL-1310 in Participants With Selected Solid Tumors","A Phase 1b\u002F2, Open-label, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors","Inclusion Criteria:\n\n* Signed informed consent\n* Adult men and women ≥18 years of age\n* Participants must have histologically confirmed, locally advanced or metastatic NeuroEndocrine Carcionomas (NEC)\n* Participants must be willing to undergo a tumor biopsy or must provide archived tumor tissue sample\n* Participants must have at least one measurable target lesion as defined by RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Life expectancy ≥ 3 months\n\nExclusion Criteria:\n\n* Participants with another known malignancy that is progressing or requires active treatment within the last 2 years\n* Clinically active central nervous system (CNS) metastases\n* Participants with leptomeningeal metastasis\n* Participants who have received any ADC with a payload of topoisomerase I inhibitor (e.g., exatecan derivative)or had received topoisomerase I inhibitor (e.g., irinotecan) as the immediate prior therapy that the participant had progressed from.\n* Treatment with any systemic anti-cancer treatment or other investigational products\u002Fdevice within 3 weeks before the first dose of study treatment\n* Non-palliative radiotherapy within 2 weeks to non-thoracic area or within 4 weeks to the thoracic area prior to first dose of study treatment or a history of radiation pneumonitis\n* Major surgery within 4 weeks of the first dose of study treatment\n* Hypersensitivity to any ingredient of the study treatment\n* Out of range value (as defined in protocol) within 10 days prior to the first dose of study treatment\n* Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study treatment\n* Lung-specific intercurrent clinically significant illnesses and any autoimmune, connective tissue, or inflammatory disorders including but not limited to pneumonitis\n* Has a history of (noninfectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening\n* Pregnant or nursing (lactating) women\n* Participants who have been on concomitant strong CYP3A or CYP2D6 inhibitors within 14 days or 5 half-lives before the first dose of study treatment, whichever is longer",{"count":58,"type":22},166,[25,60],"PHASE2",[31],"RECRUITING",{"date":40,"type":41},{"date":65,"type":41},"2025-05-12",{"date":67,"type":22},"2028-04",{"name":69,"class":70},"Zai Lab (Shanghai) Co., Ltd.","INDUSTRY",23,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":49},"100652820","phase-1-a-study-of-bl-m08d-in-patients-with-locally-advanced-or-metastatic-digestive-tract-tumors-and-other-solid-tumors-100652820","NCT07780318","A Study of BL-M08D in Patients With Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors","A Phase Ib\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M08D1 for Injection in Patients With Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restriction;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Locally advanced or metastatic gastrointestinal tumors and other solid tumors;\n6. Agree to provide archival tumor tissue specimens from the primary or metastatic site within 3 years, or fresh tissue samples;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within 2 weeks prior to the first dose;\n9. Toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;\n11. Organ function levels must meet the requirements;\n12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × upper limit of normal;\n13. Urine protein ≤1+ or ≤1000 mg\u002F24 h;\n14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with serum pregnancy results being negative, and they must be non-lactating; all enrolled patients (regardless of male or female) must adopt adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after the completion of treatment;\n15. The trial participant is capable and willing to comply with the visit schedule, treatment plan, laboratory tests, and other study-related procedures specified in the protocol.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biological therapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;\n2. History of severe cardiac or cerebrovascular disease;\n3. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n4. Active autoimmune diseases and inflammatory diseases;\n5. Diagnosis of another malignant tumor within 5 years prior to the first dose;\n6. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n7. Hypertension inadequately controlled by antihypertensive medication;\n8. Poorly controlled blood glucose;\n9. History of interstitial lung disease requiring hormone therapy, or current ILD, or radiation pneumonitis of Grade ≥2;\n10. Severe impairment of respiratory function;\n11. Active central nervous system metastases;\n12. Previous or concurrent central nervous system disorders;\n13. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M08D1;\n14. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;\n15. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n16. Active infection requiring systemic treatment within 4 weeks prior to the first study drug administration;\n17. Pleural, abdominal, or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first study drug administration;\n18. Imaging findings indicating tumor invasion or encasement of abdominal, thoracic, cervical, or other regions;\n19. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;\n20. Pregnant or breastfeeding women;\n21. Other conditions deemed by the investigator to make the patient unsuitable for participation in this clinical trial.","75 Years",{"count":81,"type":22},60,[25,60],"This Phase Ib\u002FII study is a clinical trial exploring the efficacy and safety of BL-M08D1 for injection in patients with locally advanced or metastatic digestive tract tumors and other solid tumors.",[85,31],"Digestive Tract Tumors","2026-08-19",{"date":40,"type":41},{"date":89,"type":22},"2026-09",{"date":91,"type":22},"2028-12",{"name":93,"class":70},"Sichuan Baili Pharmaceutical Co., Ltd.",{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":103,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":113,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":49},"100313872","5-aza-4-thio-2-deoxycytidine-aza-tdc-in-people-with-advanced-solid-tumors-100313872","NCT03366116","5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in People With Advanced Solid Tumors","Phase I Trial of 5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in Patients With Advanced Solid Tumors","* INCLUSION CRITERIA:\n* Patients must have histologically documented solid tumors whose disease has progressed on standard therapy or for which there is no available standard therapy.\n* Age \\>=18 years of age.\n* ECOG performance status \\\u003C= 2.\n* Patients must have normal organ and marrow function as defined below:\n\n  * absolute neutrophil count \\>= 1,500\u002FmcL\n  * platelets \\>=100,000\u002FmcL\n  * total bilirubin \\\u003C=1.5 X institutional upper limit of normal (\\\u003C=3 x upper limit of normal in the presence of documented Gilbert s syndrome)\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C=3 X institutional upper limit of normal\n\nOR\n\n* AST(SGOT)\u002FALT(SGPT) \\\u003C=5 X institutional upper limit of normal for patients with liver metastases\n* creatinine \\\u003C=1.5X institutional upper limit of normal\n\nOR\n\n* creatinine clearance \\>=60 mL\u002Fmin\u002F1.73 m\\^2 for patients with creatinine levels above 1.5X institutional normal\n\n  * Because nucleoside analogs are known to be teratogenic, women of child-bearing potential and men must agree to use two forms of contraception (hormonal or barrier method of birth control; abstinence; sterilization) prior to study entry, for the duration of study participation, and for 3 months after completing study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use two forms of contraception prior to the study, for the duration of study participation, and for 3 months after completion of administration of Aza-TdC.\n  * Patients must have completed any chemotherapy or biologic therapy \\>= 4 weeks or 5 half-lives (whichever is shorter) (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. Patients must be \\>= 2 weeks since any prior palliative radiation or cyberknife therapy. Patients must have recovered to grade 1 from prior toxicity or adverse events. Patients on study may be eligible for palliative radiotherapy to non-targeted lesions after 2 cycles of therapy at the PI's discretion. Patients with bone metastases or hypercalcemia on intravenous bisphosphonate treatment prior to study entry may continue this treatment.\n  * Ability to understand and the willingness to sign a written informed consent document.\n  * Willingness to provide blood and urine samples for research purposes.\n  * Ability to swallow pills\u002Fcapsules.\n  * Left ventricular ejection fraction greater than 45% or the institutional lower limit of normal by either ECHO or MUGA at entry.\n  * For patients enrolled on the expansion cohort, patients must have tumor amenable to biopsy (excisional or incision biopsies of skin or H \\& N lesions under visualization) and willingness to undergo tumor biopsies.\n\nEXCLUSION CRITERIA:\n\n* Patients who are receiving any other investigational agents.\n* Pregnant women and women who are breastfeeding are excluded from this study.\n* Patients with clinically significant illnesses which would compromise participation in the study, including, but not limited to active or uncontrolled infection, immune deficiencies, known HIV infection requiring protease inhibitor therapy, known Hepatitis B, known Hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:\n\n  * Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:\n\n    * Evaluable or measurable disease outside the CNS\n    * No metastases to brain stem, midbrain, pons, medulla, or cerebellum\n    * No history of intracranial hemorrhage or spinal cord hemorrhage\n    * No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted.\n    * No neurosurgical resection or brain biopsy within 28 days prior to Cycle 1, Day 1\n  * Patients with treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:\n\n    * No stereotactic radiation or whole-brain radiation within 14 days prior to Cycle 1, Day 1\n    * Screening CNS radiographic study 2 weeks from completion of radiotherapy and \\>=1 week from discontinuation of corticosteroids. The presence of new CNS mets will not exclude the patient but provide a baseline. If the irradiated lesion showed increased edema or growth, patient may be enrolled if asymptomatic but a repeat MRI should be done within the next 2-4 weeks for follow up.\n* Malabsorption syndrome or other conditions that would interfere with intestinal absorption.",{"count":102,"type":22},75,[25],"Background:\n\nBlood, tissue, and tumor cells contain genes. Genes are made up of DNA. DNA is the \"instruction book\" for each cell. In some people with cancer, the genes that might have slowed the growth of their tumor were \"turned off.\" Researchers want to see if a new drug can turn the genes back on and slow the tumor growth. The drug is called Aza-TdC.\n\nObjective:\n\nTo test the safety of Aza-TdC, and to find out the dose of this drug that can be safely given to humans.\n\nEligibility:\n\nPeople ages 18 and older who have advanced cancer that has gotten worse after standard treatment, or for which no effective therapy exists\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nBlood and urine tests\n\nScans to measure their tumors\n\nTest to measure the electrical activity of the heart\n\nParticipants will take the study drug by mouth. The drug is given in cycles. Each cycle is 21 days (3 weeks) long.\n\nWeek 1 and week 2: participants will take the study drug once a day for 5 days. Then they will have 2 days without the drug. Week 3: no study drug is taken. This completes one cycle of treatment.\n\nFor cycle 1, participants will repeat the screening tests several times. For all other cycles, participants will have blood tests and pregnancy tests. They will have scans of their tumor every 6 weeks.\n\nThe cycle will be repeated as long as the participant tolerates the drug and the cancer is either stable or gets better.\n\nSponsoring Institute: National Cancer Institute\n\n...",[106,31],"Neoplasms",[108,109,110,111,112],"Pharmacodynamics","DNA Methylation","Pharmacokinetics","Nucleoside Analog","Epigenetics",{"date":38,"type":41},{"date":115,"type":41},"2018-11-05",{"date":117,"type":22},"2026-09-30",{"name":47,"class":48},{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":126,"targetDuration":4,"studyType":23,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":135,"leadSponsor":136,"locationsCount":49},"100652869","phase-1-a-study-of-si-b036-in-patients-with-locally-advanced-or-metastatic-gynecological-tumors-and-other-solid-tumors-100652869","NCT07778862","A Study of SI-B036 in Patients With Locally Advanced or Metastatic Gynecological Tumors and Other Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SI-B036 Bispecific Antibody Injection in Patients With Locally Advanced or Metastatic Gynecological Tumors and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restriction;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Locally advanced or metastatic gynecological tumors and other solid tumors;\n6. Agree to provide archived tumor tissue specimens from the primary or metastatic site within 2 years, or fresh tissue samples;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. ECOG performance status score of 0 or 1;\n9. Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;\n11. Organ function levels must meet the requirements;\n12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × ULN;\n13. Urine protein ≤1+ or ≤1000 mg\u002F24h;\n14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with serum pregnancy test being negative, and they must not be lactating; all enrolled patients (regardless of male or female) must use adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion;\n15. Trial participants must be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the protocol.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biological therapy, immunotherapy, or other treatments within 4 weeks or 5 half-lives prior to the first dose;\n2. Receipt of immunosuppressive drug therapy within 2 weeks prior to the first dose;\n3. History of severe cardiac or cerebrovascular disease;\n4. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n5. Active autoimmune diseases and inflammatory diseases;\n6. Prior occurrence of ≥ Grade 3 toxicity related to anti-angiogenic therapy when receiving such therapy previously;\n7. Diagnosis of another solid tumor within 5 years prior to the first dose;\n8. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n9. Poorly controlled hypertension;\n10. Diabetes mellitus with poor glycemic control;\n11. History of interstitial lung disease requiring corticosteroid therapy, or currently having ILD, or ≥ Grade 2 radiation pneumonitis;\n12. Concurrent pulmonary disease resulting in severe respiratory impairment;\n13. Active central nervous system metastases;\n14. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of SI-B036;\n15. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n16. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n17. Active infection requiring systemic therapy within 4 weeks prior to the first study drug administration;\n18. Pleural, abdominal, or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first study drug administration;\n19. Imaging findings indicating tumor invasion or encasement of major thoracic blood vessels, pericardium, or heart;\n20. Trial participants with clinically significant bleeding or significant bleeding tendency within 4 weeks prior to screening;\n21. History of fistula, gastrointestinal perforation, or abdominal abscess within 6 months prior to the first dose;\n22. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;\n23. Pregnant or breastfeeding women;\n24. Other conditions deemed by the investigator to make the participant unsuitable for participation in this clinical trial.",{"count":127,"type":22},30,[25],"This study is an open-label, multicenter, dose-escalation and expansion, non-randomized Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of SI-B036 bispecific antibody injection in patients with locally advanced or metastatic gynecological tumors and other solid tumors.",[131,31],"Gynecological Tumors","2026-08-18",{"date":40,"type":41},{"date":89,"type":22},{"date":91,"type":22},{"name":93,"class":70},{"id":138,"slug":139,"hasResults":12,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":23,"phases":146,"briefSummary":147,"conditions":148,"keywords":149,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":164},"100624853","phase-2-a-solid-tumor-study-for-long-term-treatment-of-cancer-patients-who-participated-in-adagrasib-studies-100624853","NCT07415031","A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies","Solid Tumor Study for Long Term Treatment of Cancer Patients Who Have Participated in BMS Parent Studies Investigating Adagrasib (BMS-986503)","Inclusion Criteria:\n\n* Participant is eligible to receive continued study treatment as per the parent study, and\u002For investigator assessed clinical benefit.\n* Individuals with assigned female sex at birth (AFSB) must have documented proof that they are not of childbearing potential. IOCBP participants who are sexually active must agree to follow the instructions for method(s) of contraception and included in the ICF.\n\nExclusion Criteria:\n\n* Participant is not eligible for study treatment per the parent study eligibility criteria.\n* Participants who have completed treatment with the study drugs, progressed on prior study treatment, or discontinued study treatment due to toxicity in the parent study are not eligible to receive study drug in this study.\n* Participants not receiving clinical benefit from parent study drug as assessed by the investigator.\n\nOther protocol defined inclusion\u002Fexclusion criteria applies.",{"count":145,"type":22},170,[60],"This is an open-label, solid tumor, continuation, rollover trial which enrolls participants from ongoing BMS parent studies that evaluated adagrasib (MRTX849, BMS-986503) either as monotherapy or in combination with other cancer therapies in patients with non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other advanced solid tumors.",[31],[150,151,152,153,154,155],"Adagrasib","KRAS G12C","KRAS","NSCLC","CRC","Krazati","2026-08-17",{"date":132,"type":41},{"date":159,"type":41},"2026-05-06",{"date":161,"type":22},"2028-02-16",{"name":163,"class":70},"Mirati Therapeutics Inc.",100,{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":23,"phases":174,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":192},"100323125","phase-3-long-term-safety-and-efficacy-extension-study-for-participants-with-advanced-tumors-who-are-currently-on-treatment-or-in-follow-up-in-a-pembrolizumab-mk-3475-study-mk-3475-587keynote-587-100323125","NCT03486873","Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587\u002FKEYNOTE-587)","A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants Who Are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab","Inclusion Criteria:\n\n* Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.\n* Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase.\n\nAdditional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:\n\n* Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Demonstrates adequate organ function.\n* Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of \\>30 Gray (Gy), they must have recovered from the toxicity and\u002For complications of the intervention.\n* A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.\n\nAdditional eligibility criteria for participants who enter dosing with Lenvatinib:\n\n* Adequately controlled blood pressure (BP) to \\\u003C150\u002F90 mmHg, with or without antihypertensive medications.\n* For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib.\n* Is female and not pregnant\u002Fbreastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse.\n\nExclusion Criteria:\n\n-There are no exclusion criteria to participate in MK-3475-587.\n\nParticipants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies:\n\n* Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.\n* Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has a known history of human immunodeficiency virus (HIV) infection.\n* Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.\n* Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.\n* Has hepatic decompensation (Child-Pugh score \\>6 \\[class B and C\\]).\n* Has uncontrolled thyroid dysfunction.\n* Has uncontrolled diabetes mellitus.\n* Has had an allogeneic tissue\u002Fsolid organ transplant.\n* Has a known history of active tuberculosis (TB; Bacillus tuberculosis).\n\nAdditional exclusion criteria for participants who enter dosing with Lenvatinib:\n\n* Has had major surgery within 3 weeks prior to first dose of study intervention(s).\n* Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.\n* Has urine protein ≥1 g\u002F24 hours.\n* Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).\n* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.\n* Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to \\>480 ms.\n* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.\n* Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.\n* Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.\n* Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib.",{"count":173,"type":22},3500,[175],"PHASE3","The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study.\n\nThis study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.\n\nAny participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.",[31,178],"Hematologic Malignancies",[180,181,182,183],"PD1","PD-1","PDL1","PD-L1","2026-08-14",{"date":132,"type":41},{"date":187,"type":41},"2018-08-21",{"date":189,"type":22},"2043-08-04",{"name":191,"class":70},"Merck Sharp & Dohme LLC",776,{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":200,"targetDuration":4,"studyType":23,"phases":202,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":49},"100610717","phase-1-a-study-of-shr-4610-injection-in-patients-with-advanced-solid-tumors-100610717","NCT07231211","A Study of SHR-4610 Injection in Patients With Advanced Solid Tumors","An Open-label, Multicenter Phase I\u002FII Clinical Study of SHR-4610 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy","Inclusion Criteria:\n\n1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;\n2. Age range: 18-75 years old, both male and female are welcome;\n3. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment;\n4. Have at least one measurable tumor lesion per RECIST v1.1;\n5. ECOG performance status of 0-1;\n6. Life expectancy ≥ 12 weeks;\n7. Adequate bone marrow and organ function.\n\nExclusion Criteria:\n\n1. Patients with active central nervous system metastases or meningeal metastases;\n2. Systemic antitumor therapy was received 4 weeks before the start of the study;\n3. Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion;\n4. Have poorly controlled or severe cardiovascular disease;\n5. Subjects with active hepatitis B or active hepatitis C;\n6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.",{"count":201,"type":22},258,[25,60],"This study is an open, multicenter Phase I\u002FII clinical trial, divided into two stages: dose exploration (including dose escalation and dose extension) and efficacy extension.",[31],"2026-08-13",{"date":156,"type":41},{"date":208,"type":41},"2025-11-20",{"date":210,"type":22},"2027-12",{"name":212,"class":70},"Shanghai Shengdi Pharmaceutical Co., Ltd",{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":220,"minAge":18,"maxAge":79,"enrollmentInfo":221,"targetDuration":4,"studyType":23,"phases":223,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":232,"locationsCount":49},"100652096","phase-2-a-study-of-bl-m09d1-in-patients-with-locally-advanced-or-metastatic-gynecological-malignancies-and-other-solid-tumors-100652096","NCT07769229","A Study of BL-M09D1 in Patients With Locally Advanced or Metastatic Gynecological Malignancies and Other Solid Tumors","A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M09D1 for Injection in Patients With Locally Advanced or Metastatic Gynecological Malignancies and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements;\n2. Female;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Diagnosed with endometrial cancer, cervical cancer, ovarian cancer, fallopian tube cancer, primary peritoneal carcinoma, or other solid tumors;\n6. Patients with locally advanced or metastatic gynecological malignancies and other solid tumors who have failed standard treatment or are intolerant to standard treatment;\n7. Agree to provide archived tumor tissue specimens from the primary or metastatic site within 2 years, or fresh tissue samples;\n8. Must have at least one measurable lesion as defined by RECIST v1.1;\n9. Eastern Cooperative Oncology Group performance status of 0 or 1;\n10. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n11. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;\n12. Organ function levels must meet the protocol requirements;\n13. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × upper limit of normal;\n14. Urine protein ≤1+ or ≤1000 mg\u002F24h;\n15. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, with serum pregnancy being negative, and they must be non-lactating; all enrolled patients (regardless of male or female) must use adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment;\n16. The trial participant is capable and willing to comply with the scheduled visits, treatment plan, laboratory tests, and other study-related procedures specified in the protocol.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, targeted therapy, biologic therapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;\n2. History of severe heart disease;\n3. Prolonged QT interval, complete left bundle branch block, or third-degree atrioventricular block;\n4. Active autoimmune disease or inflammatory disease;\n5. Diagnosis of active malignancy within 3 years prior to study randomization;\n6. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n7. Hypertension inadequately controlled by two antihypertensive agents;\n8. Poorly controlled blood glucose;\n9. History of interstitial lung disease requiring corticosteroid therapy, or current ILD, or grade ≥2 radiation pneumonitis;\n10. Concurrent pulmonary disease resulting in clinically severe impairment of respiratory function;\n11. Active central nervous system metastases;\n12. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M09D1;\n13. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n14. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n15. Active infection requiring systemic therapy within 4 weeks prior to the first study drug administration;\n16. Pleural, abdominal, or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first study drug administration;\n17. Participation in another clinical trial within 4 weeks or 5 half-lives prior to the first dose;\n18. Clinically significant bleeding or marked bleeding tendency within 4 weeks prior to the first study drug administration;\n19. Inflammatory bowel disease requiring symptomatic or drug intervention, or partial\u002Fcomplete intestinal obstruction within 4 weeks prior to the first study drug administration;\n20. Known psychiatric disorders that may affect compliance with the trial;\n21. Planned vaccination or administration of live vaccine within 28 days prior to the first dose;\n22. Pregnant or breastfeeding women;\n23. Other conditions deemed by the investigator to make the participant unsuitable for enrollment in this clinical trial.","FEMALE",{"count":222,"type":22},126,[60],"This study is a single-arm, open-label, multicenter, non-randomized phase II clinical study evaluating the efficacy and safety of BL-M09D1 for injection in patients with locally advanced or metastatic gynecological malignancies and other solid tumors.",[226,31],"Gynecological Malignancies","2026-08-12",{"date":156,"type":41},{"date":230,"type":22},"2026-08",{"date":91,"type":22},{"name":93,"class":70},{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":240,"targetDuration":4,"studyType":23,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":49},"100652076","phase-1-phase-iii-clinical-trials-of-shr-8203-injection-in-participants-with-advanced-solid-tumors-100652076","NCT07769242","Phase I\u002FII Clinical Trials of SHR-8203 Injection in Participants With Advanced Solid Tumors","An Open-label, Multi-center Phase I\u002FII Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-8203 Injection in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age between 18 and 75 years old, gender not limited;\n2. Be willing to participate and abide by the requirements of the research protocol, and be willing to cooperate with the follow-up.\n3. Participants with advanced or metastatic solid tumors confirmed by histological or cytological pathology who have failed standard treatment (disease progression or toxic intolerance) or have no effective standard treatment;\n4. Able to provide sufficient fresh or archived tumor tissue specimens for the third-party central laboratory designated by the sponsor.\n5. Have at least one measurable lesion as per RECIST v1.1;\n6. ECOG PS score: 0-1;\n7. Good organ function level.\n\nExclusion Criteria:\n\n1. Imaging studies show that the tumor invades major blood vessels or has an unclear boundary with blood vessels, and researchers determine that there is a risk of massive hemorrhage;\n2. Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment;\n3. Pleural effusion, pericardial effusion or peritoneal effusion accompanied by clinical symptoms, poorly controlled, or moderate to severe;\n4. Major arterial or venous thrombosis events occurred within 6 months before the first administration of medication;\n5. Participants who have experienced severe infections within one month prior to the first medication.",{"count":241,"type":22},200,[25,60],"This trial is a multicenter, open-label Phase I\u002FII clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and efficacy of SHR-8203 injection in participants with advanced solid tumors.",[31],{"date":156,"type":41},{"date":247,"type":22},"2026-09-01",{"date":249,"type":22},"2029-12-30",{"name":251,"class":70},"Beijing Suncadia Pharmaceuticals Co., Ltd",{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":260,"enrollmentInfo":261,"targetDuration":4,"studyType":23,"phases":263,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":49},"100641720","phase-2-optimizing-ancillary-therapies-with-immune-checkpoint-inhibitors-for-solid-tumors-oat-ici-100641720","NCT07661459","Optimizing Ancillary Therapies With Immune Checkpoint Inhibitors for Solid Tumors (OAT ICI)","Optimizing Ancillary Therapies (Acetaminophen, Cannabis, Antihistamines, and NSAIDS) With Immune Checkpoint Inhibitors for Solid Tumors (OAT ICI)","OAT ICI","Inclusion Criteria:\n\n* Solid tumor patients with measurable disease. Including patients with early stage and advanced stage cancer.\n* Patients who are to get neoadjuvant or induction therapy prior to planned surgery or radiation are included if definitive therapy is planned to occur at least 18 weeks after ICI initiation.\n* Treatment plan includes an immune checkpoint inhibitor (PD1 or PD-L1 inhibitor) as standard of care. Standard of care will be determined by referring to the NCCN guidelines. For rare situations where a disease is not found in the NCCN guideline, the treatment must be considered standard of care at the MCC.\n* ECOG Performance Status 0-3.\n* Life expectancy of at least 3 months.\n* Adequate hematologic, renal and hepatic function based on institutional standards.\n* Must be willing to stop\u002Fnot start daily acetaminophen during the study period\n* Must be willing to stop\u002Fnot start THC-containing agent (e.g., medical or recreational marijuana, CBD) during the study period\n* Patients willing to take a second-generation antihistamine (loratadine) and an NSAID (aspirin). Patients already taking a daily antihistamine and\u002For NSAID can participate and will continue the class of drug already being taken\n* Ability to understand and the willingness to follow study procedures, including urine testing for THC.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Contraindication to immunotherapy, aspirin, or loratadine (including patients on blood thinners or antiplatelet agents that pose a high risk of bleeding based on the treating oncologist's opinion)\n* History of allergic reactions attributed to loratadine or aspirin (true allergy, not intolerance)\n* Known immunocompromised patients; defined as disease or drug related. This includes solid organ transplant patients, patients with active human immunodeficiency virus (detectable disease within the last 60 days), and those with autoimmune diseases on immune modulating drugs (disease modifying agents or steroids at a prednisone equivalent dose \\> 10 mg daily).\n* Early-stage disease patients who are scheduled for definitive therapy in less than 126 days from treatment initiation\n* Patients must not have had prior ICIs for advanced disease except as neoadjuvant + adjuvant therapy. Patients with recurrence after definitive therapy may have had prior ICIs for earlier stage disease if it was \\> 6 months since the last dose.\n* Patients on an interventional cancer study\n* History or evidence of any other clinically significant condition that, in the opinion of the investigator or treating physician, would pose a risk to subject safety or interfere with study procedures, evaluation or completion","99 Years",{"count":262,"type":22},98,[60],"This study evaluates whether optimization of ancillary therapies can improve the efficacy of immune checkpoint therapy in participants with solid tumors. The ancillary therapies being optimized include the avoidance of daily acetaminophen and cannabis\u002FTHC\u002FCBD while prescribing aspirin and loratadine. The goal is to see if optimizing these four drugs can improve the efficacy of the treatment compared to a matched historical control.",[31],"2026-08-11",{"date":184,"type":41},{"date":269,"type":41},"2026-06-26",{"date":271,"type":22},"2027-07-31",{"name":273,"class":274},"Val Adams","OTHER",{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":23,"phases":284,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":288,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":295},"100624937","phase-1-a-study-of-gen1106-in-participants-with-solid-tumors-100624937","NCT07416123","A Study of GEN1106 in Participants With Solid Tumors","First-In-Human, Open-Label, Dose Escalation and Expansion Trial to Evaluate the Safety, Pharmacokinetics and Efficacy of GEN1106 in Participants With Solid Tumors","Key Inclusion Criteria:\n\n* Have received and progressed on, been intolerant to, or be ineligible for all available standard of care (SoC) therapies known to provide a survival and\u002For quality of life benefit for their tumor type. These therapies should include chemotherapy, anti-programmed cell death protein 1 (PD-1)\u002Fprogrammed cell death ligand 1 (PD-L1) therapies, enfortumab vedotin (EV), and other therapies, where applicable.\n* Have measurable disease according to RECIST v1.1.\n* Have Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1 at screening.\n* Part 1: Have histologically or cytologically confirmed diagnosis of cancer as specified per protocol.\n* Parts 2 and 3: Have histologically or cytologically confirmed diagnosis of metastatic urothelial carcinoma (mUC).\n\nKey Exclusion Criteria:\n\n* Prior treatment with topoisomerase 1 inhibitor-based antibody-drug conjugate (ADC) therapy.\n* Treatment with an anticancer agent within 4 weeks or for systemic therapies within 5 half-lives of the drug, whichever is shorter, prior to trial treatment administration.\n* Has clinically significant toxicities from previous anticancer therapies that have not resolved to baseline levels or to grade 1 or lower, except for alopecia, anorexia, vitiligo, fatigue, hyperthyroidism, hypothyroidism, and peripheral neuropathy. Anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy must have recovered to grade 2.\n\nNote: Other protocol-defined Inclusion and Exclusion criteria may apply.",{"count":283,"type":22},103,[25],"The purpose of this trial is to learn about the safety and effectiveness of GEN1106 when it is used for the treatment of participants with certain types of cancer.\n\nThe trial has multiple parts. The first part of the trial tests different doses of GEN1106 to find out if it is safe and determine what are the best doses to use. The second and third parts continues to test the safety of and how well GEN1106 works in additional participants with a specific cancer type and at doses chosen based on results from the first part of the trial.\n\nFor each participant, the trial will last approximately 17 months but will vary for each person. This includes up to 21 days for screening prior to receiving trial treatment, approximately 5 months of treatment (the duration of treatment may vary for each participant), and approximately 11 months of follow up after trial treatment ends (the duration of follow up may vary for each participant).\n\nParticipation in the trial will require visits to the site, with more frequent visits during the first 6 weeks of treatment and then less frequent visits afterwards. At site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, computed tomography \\[CT\\] scans) to monitor whether the treatment is safe and effective.\n\nAll participants will receive active drug; no one will be given placebo.",[31,287],"Urothelial Carcinoma",{"date":227,"type":41},{"date":290,"type":41},"2026-04-14",{"date":292,"type":22},"2029-06-25",{"name":294,"class":70},"Genmab",10,{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":303,"targetDuration":4,"studyType":23,"phases":304,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":310,"completionDateStruct":311,"leadSponsor":312,"locationsCount":313},"100651677","phase-1-a-study-of-si-b036-in-patients-with-locally-advanced-or-metastatic-head-and-neck-tumors-and-other-solid-tumors-100651677","NCT07763639","A Study of SI-B036 in Patients With Locally Advanced or Metastatic Head and Neck Tumors and Other Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SI-B036 Bispecific Antibody Injection in Patients With Locally Advanced or Metastatic Head and Neck Tumors and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements;\n2. No gender restriction;\n3. Age: ≥18 years and ≤75 years;\n4. Life expectancy ≥3 months;\n5. Locally advanced or metastatic head and neck tumors and other solid tumors;\n6. Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions within 2 years;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. ECOG performance status score of 0 or 1;\n9. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;\n11. Organ function levels must meet the protocol requirements;\n12. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN);\n13. Urine protein ≤2+ or ≤1000 mg\u002F24h;\n14. For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days prior to the start of treatment, with a negative result, and they must not be lactating. All enrolled patients (regardless of gender) must adopt adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after the completion of treatment;\n15. Participants must be capable of and willing to comply with the study visits, treatment plans, laboratory tests, and other study-related procedures as specified in the protocol.\n\nExclusion Criteria:\n\n1. Received chemotherapy, biotherapy, immunotherapy, or other systemic anti-tumor therapies within 4 weeks or 5 half-lives prior to the first dose;\n2. Received immunosuppressive medications within 2 weeks prior to the first dose;\n3. History of severe cardiac or cerebrovascular disease;\n4. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n5. Active autoimmune diseases and inflammatory diseases;\n6. History of ≥ Grade 3 toxicity related to anti-angiogenic therapy when previously receiving such treatment;\n7. Diagnosis of another solid malignancy within 5 years prior to the first dose;\n8. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n9. Uncontrolled hypertension;\n10. Diabetes mellitus with poor glycemic control;\n11. History of interstitial lung disease (ILD) requiring corticosteroid therapy, or current ILD, or ≥ Grade 2 radiation pneumonitis;\n12. Concurrent pulmonary disease resulting in severe impairment of respiratory function;\n13. Active central nervous system (CNS) metastases;\n14. History of allergy to recombinant humanized or human-mouse chimeric antibodies, or allergy to any excipient of SI-B036;\n15. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n16. Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus (HBV) infection, or active hepatitis C virus (HCV) infection;\n17. Active infection requiring systemic therapy within 4 weeks prior to the first dose of study drug;\n18. Pleural, abdominal, pelvic, or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first dose of study drug;\n19. Imaging findings indicate that the tumor has invaded or encased the great thoracic vessels, pericardium, or heart;\n20. Clinically significant hemorrhage or obvious bleeding tendency within 4 weeks prior to screening;\n21. History of fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first dose;\n22. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;\n23. Pregnant or lactating women;\n24. Any other conditions that, in the investigator's judgment, make the participant unsuitable for enrollment in this clinical trial.",{"count":127,"type":22},[25],"This is an open-label, multicenter, non-randomized Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SI-B036 Bispecific Antibody Injection in patients with locally advanced or metastatic head and neck tumors and other solid tumors.",[307,31],"Head and Neck Tumors","2026-08-10",{"date":205,"type":41},{"date":230,"type":22},{"date":91,"type":22},{"name":93,"class":70},2,{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":23,"phases":323,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":327,"startDateStruct":328,"completionDateStruct":329,"leadSponsor":330,"locationsCount":49},"100651660","phase-1-a-study-of-bl-arc002-in-patients-with-locally-advanced-or-metastatic-gastrointestinal-tumors-and-other-solid-tumors-100651660","NCT07763652","A Study of BL-ARC002 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-ARC002 Injection in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements;\n2. No gender restriction;\n3. Age: ≥18 and ≤75 years (Phase Ia); ≥18 years (Phase Ib);\n4. Expected survival ≥3 months;\n5. Locally advanced or metastatic esophageal squamous cell carcinoma, gastric cancer, colorectal cancer, or other solid tumors;\n6. Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions obtained within 2 years;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n9. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;\n11. Organ function levels must meet the protocol-specified requirements;\n12. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN);\n13. Urine protein ≤2+ or ≤1000 mg\u002F24h;\n14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days prior to the start of treatment, with a negative serum pregnancy test result, and they must be non-lactating; all study participants (both male and female) must use adequate barrier contraception throughout the entire treatment period and for 7 months after the completion of treatment.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biotherapy, immunotherapy, or other anti-tumor therapies within 4 weeks or 5 half-lives prior to the first dose;\n2. History of severe cardiac disease;\n3. QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block;\n4. Active autoimmune diseases and inflammatory diseases;\n5. Diagnosis of another malignant tumor within 5 years prior to the first dose;\n6. Hypertension inadequately controlled by two antihypertensive agents;\n7. History of interstitial lung disease (ILD) requiring corticosteroid therapy, or current ILD, or radiation pneumonitis of Grade ≥2;\n8. Active central nervous system (CNS) metastases;\n9. Subjects with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-ARC002;\n10. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n11. Cumulative anthracycline dose \\> 360 mg\u002Fm² from prior (neo)adjuvant anthracycline-based therapy;\n12. Positive for human immunodeficiency virus (HIV) antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n13. Active infection requiring systemic therapy;\n14. Participation in another clinical trial within 4 weeks prior to the first dose;\n15. Pregnant or breastfeeding women;\n16. Subjects with claustrophobia or inability to lie flat for the duration of required examinations due to various reasons;\n17. Any other conditions that, in the investigator's judgment, make the subject unsuitable for participation in this clinical trial.",{"count":322,"type":22},22,[25],"This is an open-label, multicenter, non-randomized Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-ARC002 Injection in patients with locally advanced or metastatic solid tumors.",[326,31],"Gastrointestinal Tumors",{"date":205,"type":41},{"date":230,"type":22},{"date":91,"type":22},{"name":93,"class":70},{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":23,"phases":341,"briefSummary":342,"conditions":343,"keywords":344,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":362},"100633083","phase-3-a-study-to-evaluate-chemotherapy-with-or-without-incb161734-in-previously-untreated-kras-g12d-mutated-metastatic-pancreatic-ductal-adenocarcinoma-100633083","NCT07522073","A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma","A Randomized, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303)","DAWN-303","Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic PDAC with a KRAS G12D mutation\n* No prior systemic treatment in the metastatic setting\n* ECOG Performance status 0-1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Prior treatment with any KRAS inhibitor\n* Chronic or current active infection requiring systemic treatment within 1 week prior to the first dose of study drug\n* Known active CNS metastases\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.",{"count":340,"type":22},588,[175],"The purpose of this study is to evaluate the efficacy and safety of standard chemotherapy with or without INCB161734 in participants with metastatic pancreatic ductal adenocarcinoma (PDAC).",[31],[345,346,347,348,349,350,351,352],"INCB161734","KRASG12D Mutation","pancreatic ductal adenocarcinoma (PDAC)","KRAS G12D inhibitor","KRAS inhibitor","KRAS mutation","pancreatic cancer","metastatic pancreatic cancer","2026-08-04",{"date":355,"type":41},"2026-08-06",{"date":357,"type":41},"2026-04-09",{"date":359,"type":22},"2029-03-19",{"name":361,"class":70},"Incyte Corporation",219,{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":23,"phases":372,"briefSummary":373,"conditions":374,"keywords":375,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":387,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":322},"100608004","phase-1-a-study-to-evaluate-inca036873-in-participants-with-advanced-solid-tumors-and-hematological-malignancies-100608004","NCT07195916","A Study to Evaluate INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies","A Phase 1, Open-Label, Multicenter Study of INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies","Inclusion Criteria:\n\n* Age ≥18 years.\n* ECOG performance status of 0 or 1.\n* Histologically confirmed:\n\n  * Clear cell renal cell carcinoma (ccRCC).\n  * Diffuse large B-cell lymphoma (DLBCL, NOS).\n  * High-grade B-cell lymphoma (HGBCL).\n  * Peripheral T-cell lymphoma (PTCL, incl. NOS and ALCL).\n  * Cutaneous T-cell lymphoma (CTCL, incl. MF or SS ≥Stage IIB with B0\u002FB1 blood involvement).\n* Disease progression, relapse, or refractory to prior therapy:\n\n  * ccRCC: ≥1 prior line incl. ICI + TKI.\n  * DLBCL\u002FHGBCL: ≥2 prior lines incl. immunochemotherapy and salvage.\n  * PTCL\u002FCTCL: ≥1 prior systemic therapy.\n* Measurable disease by RECIST v1.1 (ccRCC), Lugano 2014 (lymphomas), or ISCL\u002FUSCLC\u002FEORTC (CTCL).\n* Tumor tissue available for central testing.\n\nExclusion Criteria:\n\n* Untreated or progressive CNS disease unless previously treated and stable.\n* Other active invasive malignancy within 2 years (except certain low-risk cancers).\n* Prior CD70-targeting therapy, including CAR T.\n* ASCT or CAR T ≤12 weeks before enrollment; prior organ or allogeneic transplant.\n* Unresolved ≥Grade 2 toxicity from prior therapy (with exceptions).\n* Primary immunodeficiency or active autoimmune disease requiring immunosuppression.\n* Active HBV, HCV, HIV, or other chronic infections requiring systemic therapy.\n* Pregnancy, breastfeeding, or unwillingness to use effective contraception.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.",{"count":371,"type":22},280,[25],"A study to evaluate the safety and tolerability of INCA036873 in participants with advanced solid tumors and hematological malignancies.",[31,178],[376,377,378,379,380,381,382,383,384,385,36,386],"Advanced solid tumors","Metastatic solid tumors","Clear cell renal cell carcinoma (ccRCC)","Diffuse large B-cell lymphoma (DLBCL)","High-grade B-cell lymphoma (HGBCL)","Peripheral T-cell lymphoma (PTCL, incl. ALCL)","Cutaneous T-cell lymphoma (CTCL, incl. MF and SS)","Non-Hodgkin lymphoma (NHL)","CD70","Bispecific antibody","T-cell engager",{"date":355,"type":41},{"date":389,"type":41},"2026-01-08",{"date":391,"type":22},"2028-08-18",{"name":361,"class":70},{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":23,"phases":402,"briefSummary":403,"conditions":404,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":413},"100475509","phase-1-a-study-to-test-how-different-doses-of-bi-1703880-in-combination-with-ezabenlimab-are-tolerated-in-people-with-different-types-of-advanced-cancer-solid-tumours-100475509","NCT05471856","A Study to Test How Different Doses of BI 1703880 in Combination With Ezabenlimab Are Tolerated in People With Different Types of Advanced Cancer (Solid Tumours)","Phase Ia, First in Human Open Label Dose Escalation Trial Evaluating Intravenous BI 1703880 in Combination With Intravenous Ezabenlimab for Treatment of Advanced Solid Tumours","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of an advanced, unresectable and\u002For metastatic or relapsed\u002Frefractory solid tumour. Patient must have at least one measurable lesion (according to Response Criteria in Solid Tumours (RECIST 1.1)).\n* Patient must have exhausted or refused established treatment options for the malignant disease, or is not eligible for established treatment options.\n* Has a lesion amenable to pre-treatment and on-treatment biopsy and patient consents to both biopsies.\n* Medically fit and willing to undergo all mandatory trial procedures.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* Adequate organ function or bone marrow reserve as demonstrated at screening by the following laboratory values:\n\n  * Absolute neutrophil count ≥ 1.5x10\\^9\u002FL (≥ 1.5x10\\^3\u002FμL, ≥ 1500\u002Fmm3); platelet count ≥ 100x10\\^9\u002FL (≥ 100x10\\^3\u002FμL, ≥ 100x10\\^3\u002Fmm3), without the use of hematopoietic growth factors within 4 weeks of start of trial medication\n  * Haemoglobin ≥ 90 g\u002FL (≥ 9.0 g\u002FdL, ≥ 5.6 mmol\u002FL)\n  * Estimated glomerular filtration rate (eGFR) ≥60 ml\u002Fmin\u002F1.73m\\^2 (as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula)\n  * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN if transaminase elevation is attributable to liver metastases.\n  * Total bilirubin ≤ 1.5 x ULN, except for patients with Gilbert's syndrome: total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN\n  * partial thromboplastin time (PTT) \u002F activated partial thromboplastin time (aPTT) \\\u003C1.5 x ULN\n* Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the informed consent form (ICF).\n* Signed and dated written ICF in accordance with International Council for Harmonisation- Good Clinical Practice (ICH-GCP) and local legislation, obtained before performing any protocol related procedures that are not part of normal standard of practice care. Note: If a patient declines to participate in the voluntary biobanking component of the trial, he\u002Fshe will not be excluded from other aspects of the trial.\n\nFurther inclusion criteria apply\n\nExclusion Criteria:\n\n* Any investigational or antitumour treatment within 4 weeks or 5 half-life periods prior to the first treatment whichever is shorter.\n* Prior STING agonist therapy.\n* Prior intolerability of a anti-programmed cell death protein 1 (PD-1) or anti-programmed cell death ligand 1 (PD-L1) therapy.\n* History of allergy or hypersensitivity to study agent components.\n* Immunosuppressive therapies including, but not limited to, systemic corticosteroids at doses exceeding \\>10 mg\u002Fday of prednisone or equivalent, and tumour necrosis factor-alpha blockers.\n* Persistent toxicity from previous treatments (including immune related Adverse Events (irAEs)) that has not resolved to Grade ≤1, except for alopecia, xerostomia, and immunotherapy related endocrinopathies.\n* Evidence of active, non-treatment related autoimmune disease, except for endocrinopathies.\n* History or complication of pneumonitis or interstitial lung disease within the last 12 months, or any prior pneumonitis related to immunotherapy.\n\nFurther exclusion criteria apply",{"count":401,"type":22},66,[25],"This study is open to adults with different types of advanced cancer. People can take part if previous treatment was not successful, or no treatment exists.\n\nThe purpose of this study is to find the highest dose of a medicine called BI 1703880 that people with advanced cancer can tolerate when taken together with ezabenlimab.\n\nBI 1703880 and ezabenlimab are medicines that may help the immune system fight cancer. In this study, BI 1703880 is given to people for the first time.\n\nParticipants get BI 1703880 and ezabenlimab as infusions into a vein. During the first 6 weeks, they get BI 1703880 once a week. Later, they get BI 1703880 every 3 weeks. After the first 3 weeks, they get ezabenlimab in addition every 3 weeks.\n\nParticipants can get BI 1703880 for up to 1 year and ezabenlimab for up to 2 years as long as they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. At these visits, the doctors check participants' health and take note of any unwanted effects.",[31],"2026-08-03",{"date":353,"type":41},{"date":408,"type":41},"2023-02-24",{"date":410,"type":22},"2029-01-02",{"name":412,"class":70},"Boehringer Ingelheim",13,{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":420,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":422,"targetDuration":4,"studyType":23,"phases":424,"briefSummary":426,"conditions":427,"keywords":440,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":4},"100646600","a-multicenter-randomized-open-label-trial-evaluating-ctdna-guided-interruption-versus-standard-of-care-immune-checkpoint-inhibitor-ici-therapy-in-patients-with-advanced--metastatic-solid-tumors-100646600","NCT07689812","A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced \u002F Metastatic Solid Tumors.","A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Continuous Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced\u002FMetastatic Solid Tumors","SIGNAL-IO 301","Inclusion Criteria:\n\nGeneral inclusion criteria includes the following selection criteria to be eligible for inclusion in any aspect of the study. Eligibility will be assessed by the investigator:\n\n1. Signed Informed consent\n2. Age ≥ 18 years\n3. ECOG 0-2.\n4. Histologically confirmed advanced\u002Fmetastatic solid tumors including:\n\n   1. Melanoma: Unresectable recurrent, advanced, or metastatic\n   2. NSCLC: Advanced or metastatic\n   3. MSI-High\u002FdMMR CRC: Metastatic\n   4. RCC: Unresectable recurrent, advanced, or metastatic\n   5. Other: Metastatic solid tumors\n5. Received first line ICI monotherapy or dual-ICI therapy (e.g., PD-1\u002FCTLA-4 combination therapy) for a minimum of 12 months (maximum of 15 months) for NSCLC, RCC \\& other metastatic solid tumors, or for a minimum of 6 months (maximum of 9 months) for melanoma and MSI-High \u002FdMMR CRC. Exceptions permitted:\n\n   * For patients with NSCLC: First line platinum-based chemo-ICI regimens if on maintenance ICI +\u002F- pemetrexed.\n   * For patients with melanoma: nivolumab\u002Frelatlimab is permissible.\n6. Radiographic CR\u002FPR: Participants must have CR or PR at the last assessment performed within 6 weeks before randomization according to RECIST v1.1 using a diagnostic CT and\u002For MRI. Radiographic assessment must be confirmed by the BICR prior to randomization.\n7. Known ctDNA-negative with a tissue-informed assay\n\n   * ≥ 2 consecutive ctDNA-negative results at least 6 weeks apart; last test within 1 month of enrollment.\n   * Note: A confirmatory Signatera Genome negative test must be completed at enrollment if previous ctDNA testing performed for clinical care was done with a test other than Signatera Genome.\n8. Adequate organ function:\n\n   1. Hematology: ANC ≥1500\u002FμL; Platelets ≥100000\u002FμL;Hemoglobin ≥9.0g\u002FdL;\n   2. Renal: Serum Cr ≤1.5×ULN or calculated CrCl ≥60 mL\u002Fmin (using Cock-Gault formula);\n   3. Hepatic: Total bilirubin ≤1.5 ×ULN or, for participants with total bilirubin levels \\>1.5×ULN, direct bilirubin within normal limits; AST (SGOT) and ALT (SGPT) ≤2.5×ULN;\n   4. Coagulation: INR or PT, activated partial thromboplastin time (APTT) ≤1.5×ULN Note: Laboratory assessments performed as part of standard of care evaluations during immunotherapy treatment administration may be used to satisfy these eligibility criteria, provided they are obtained within 28 days of enrollment.\n9. Recovery to baseline or ≤ Grade 1 common terminology criteria for adverse events (CTCAE) v6 from AE(s) related to any prior treatments unless AE(s) are deemed clinically non-significant (e.g., Grade 2 alopecia) by the Investigator and\u002For stable on supportive therapy.\n10. No prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cancer, or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since completion of definitive therapy\n11. Participants must be willing and able to comply with study visits, treatment plans, laboratory tests, and other study procedures\n12. Women of child-bearing potential (WOCBP) and male participants partnering with WOCBP must agree to use highly effective contraception during the treatment phase and at least 180 days post last dose\n13. Patients must be willing to discontinue clinically-directed ctDNA testing for treatment response monitoring during the period of clinical trial testing as dictated by the protocol.\n\nExclusion Criteria\n\nPatients are not eligible for the study if they meet any of the following criteria, as assessed by the investigator:\n\n1. Available alternate treatment options with curative intent, e.g. surgery and \u002F or RT and \u002F or Chemotherapy.\n2. Symptomatic or progressing CNS metastases; or presence of leptomeningeal disease.\n3. Patient has active autoimmune disease that required systemic treatment in the past 2 years, is immunocompromised in the opinion of the Investigator, or is receiving systemic immunosuppressive treatment. (Note: Participants with splenectomy are allowed.) Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment.\n4. Patient is receiving systemic steroid therapy ≤3 days prior to enrollment or receiving any other form of immunosuppressive medication with the exception of daily steroid replacement therapy. Note: Use of inhaled corticosteroids, local steroid injection, or steroid eye drops is allowed.\n5. Had allogeneic tissue\u002Fsolid organ transplantation.\n6. Interstitial lung disease or history of pneumonitis that has required oral or IV steroids. Note: Patients with lymphangitic carcinomatosis secondary to NSCLC can be considered as eligible.\n7. Has received or will receive a live vaccine within 30 days prior to enrollment (seasonal flu vaccines that do not contain live vaccine are permitted).\n8. Active infection requiring intravenous systemic therapy.\n9. Known history of human immunodeficiency virus (HIV).\n10. Known active Hepatitis B or C.\n11. Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n12. Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of enrollment.\n13. Use of any commercial ctDNA or liquid biopsy monitoring outside of the study protocol during the treatment monitoring phase within the protocol.",{"count":423,"type":22},920,[425],"NA","This is a multicenter, open-label, randomized (1:1) trial designed to evaluate whether ctDNA-guided interruption of immune-checkpoint inhibitor (ICI) therapy provides comparable survival to standard of care (SoC) continuous ICI therapy in patients with histologically confirmed advanced\u002Fmetastatic non-small cell lung cancer (NSCLC), melanoma, microsatellite instability-high (MSI-High)\u002FDeficient Mismatch Repair (dMMR) colorectal cancer (CRC), renal cell carcinoma (RCC) and other solid tumors. This study will be conducted in up to 100 sites.",[428,429,430,153,431,432,154,433,434,435,436,31,437,438,439],"NSCLC (Advanced Non-small Cell Lung Cancer)","NSCLC (Non-small Cell Lung Cancer)","NSCLC (Non-small Cell Lung Carcinoma)","Melanoma (Skin Cancer)","Melanoma (Skin) Stage IV","MSI High Colorectal Cancer","DMMR Colorectal Cancer","RCC, Renal Cell Cancer","RCC","Metastatic Solid Tumors","Advanced Solid Tumors","Advanced Solid Tumors Cancer",[441,442,443,444,445,153,446,447,448,449,154,450,436,377,451,452,453,454,455,456,457],"ctDNA","Circulating tumor DNA","Immune checkpoint inhibitor","ICI","Non-small cell lung cancer","Melanoma","Microsatellite Instability-High\u002Fdeficient Mismatch Repair","MSI-High\u002FdMMR","Colorectal Cancer","Renal cell carcinoma","Signatera","Molecular residual disease","MRD","Biomarker-guided therapy","Adjuvant therapy","Tumor-informed assay","Advanced solid tumor","2026-07-31",{"date":353,"type":41},{"date":461,"type":22},"2026-12",{"date":463,"type":22},"2034-03",{"name":465,"class":70},"Natera, Inc.",{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":23,"phases":475,"briefSummary":476,"conditions":477,"keywords":478,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":499},"100630823","phase-2-a-study-of-bms-986504-monotherapy-and-in-combination-with-other-agents-in-participants-with-advanced-andor-metastatic-solid-tumors-with-homozygous-mtap-deletion-mountaintap-5-100630823","NCT07492680","A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and\u002For Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)","A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination With Other Agents in Participants With Advanced and\u002For Metastatic Solid Tumors With Homozygous MTAP Deletion","Inclusion Criteria:\n\n* Participant must have histologically confirmed diagnosis of advanced and\u002For metastatic solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.\n* Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metastatic disease.\n* Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline.\n* Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer must be ≤ 2 × ULN.\n* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor.\n* Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).\n* Participants must not have history of gastrointestinal disease or other gastrointestinal conditions within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) likely to alter absorption of study treatment or result in inability to swallow oral medications.\n* Participants must not have inadequate organ function, as determined by laboratory testing within the screening period.\n* Participants must not have active viral HBV or HCV hepatitis.\n* Other protocol defined inclusion\u002Fexclusion criteria applies.",{"count":474,"type":22},260,[60],"This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and\u002For metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which BMS-986504 is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-986504 alone and in combination regimens.",[31],[479,480,481,482,483,484,485,446,153,486,487,488,489],"MTAP","CDKN2A","PRMT5","MountainTAP","Targeted therapy","Brain cancer","GBM","Lung cancer PDAC","Pancreatic cancer","Navlimetostat","Navli","2026-07-29",{"date":492,"type":41},"2026-07-30",{"date":494,"type":41},"2026-07-27",{"date":496,"type":22},"2032-05-20",{"name":498,"class":70},"Bristol-Myers Squibb",57,{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":23,"phases":510,"briefSummary":511,"conditions":512,"keywords":514,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":7},"100480450","phase-1-a-phase-1-study-of-ab521-monotherapy-and-combination-therapies-in-renal-cell-carcinoma-and-other-solid-tumors-100480450","NCT05536141","A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors","A Phase 1, Open-label, Dose Escalation and Dose Expansion Study, to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB521 Monotherapy and Combination Therapies in Participants With Clear Cell Renal Cell Carcinoma and Other Solid Tumors","ARC-20","Key Inclusion Criteria:\n\n* Must have at least one measurable lesion per RECIST guidance\n* Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1\n* Disease-specific criteria for dose escalation:\n\n  * Participants may have any pathologically confirmed solid tumor type where no other treatment options are available\n  * Creatinine clearance ≥ 40 mL\u002Fmin\n\nDisease-specific criteria for dose-expansion:\n\n* Histologically confirmed ccRCC\n* Creatinine clearance ≥ 40 mL\u002Fmin\n\nKey Exclusion Criteria:\n\n* Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product\n* Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with a participant's participation in the clinical study or make the administration of investigational product hazardous\n* History of trauma or major surgery within 28 days prior to the first dose of investigational product\n* For all expansion cohorts: prior treatment with an hypoxia inducible factor (HIF)-2α inhibitor. For the casdatifan + cabozantinib combination cohort, any prior treatment with cabozantinib. For casdatifan + zimberelimab and casdatifan + zimberelimab + ipilimumab cohorts, any prior systemic treatment when cancer is present.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":509,"type":22},362,[25],"The purpose of this study is to evaluate the safety and tolerability of:\n\n* casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and\n* casdatifan monotherapy and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.",[513,31],"Clear Cell Renal Cell Carcinoma",[513,515,516,517,518,519,520],"AB521","Casdatifan","Kidney Cancer","Zimberelimab","AB122","Hif2a","2026-07-28",{"date":490,"type":41},{"date":524,"type":41},"2022-10-26",{"date":526,"type":22},"2029-03",{"name":528,"class":70},"Arcus Biosciences, Inc.",{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":535,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":23,"phases":538,"briefSummary":539,"conditions":540,"keywords":553,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":567,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":574},"100586467","phase-1-safety-and-preliminary-anti-tumor-activity-of-tyra-430-in-advanced-hepatocellular-carcinoma-and-other-solid-tumors-with-activating-fgffgfr-pathway-aberrations-100586467","NCT06915753","Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF\u002FFGFR Pathway Aberrations","A Multicenter, Open-label, First-in-Human Study of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF\u002FFGFR Pathway Aberrations","SURF431","Key Inclusion Criteria:\n\nAll Patients:\n\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.\n* Adequate end organ function.\n* Ability to swallow oral formulations.\n* Ability to understand and willingness to sign the ICF.\n\nPart A:\n\n* Histologically confirmed locally advanced unresectable\u002Fmetastatic HCC or histologically confirmed advanced solid tumor with documented FGF\u002FFGFR pathway alterations\n* For participants with histologically confirmed locally advanced or metastatic HCC:\n\n  * Barcelona Clinic Liver Cancer (BCLC) stage B that is not eligible for locoregional therapy, or stage C.\n  * Child-Pugh Score class A\n* Must have previously received SOC appropriate for their tumor type. Any number of prior therapies, including FGFR inhibitors, are permitted.\n* Agree to provide archival tumor tissue no older than 2 years from the time of enrollment, if available. If an archived specimen is not available, a biopsy is not required.\n\nPart B, Cohort 1:\n\n* Histologically confirmed locally advanced\u002Fmetastatic HCC who have previously received standard of care.\n* Barcelona Clinic Liver Cancer (BCLC) stage B that is not eligible for locoregional therapy, or stage C.\n* Child-Pugh Score class A\n* Availability of an archival formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen obtained ≤2 years prior to screening for submission to sponsor-designated central laboratory for FGF19 IHC testing.\n* At least 1 measurable lesion by RECIST v1.1.\n\nPart B, Cohort 2:\n\n* Histologically confirmed advanced solid tumor except FGFR3-altered urothelial carcinoma and primary central nervous system tumors who have previously received standard of care. Note: Participants with confirmed diagnosis of locally advanced or metastatic HCC are not eligible for Cohort 2.\n* Must have an eligible activating gain-of-function alteration in the FGFR3 or FGFR4 gene, or focal amplifications of FGF19\n* Archival tumor tissue biopsy specimen no older than 2 years from the time of enrollment, if available. If a tissue biopsy specimen is not available, a biopsy is not required.\n* At least 1 measurable lesion by RECIST v1.1.\n\nKey Exclusion Criteria:\n\nAll Patients:\n\n* Have disease that is suitable for local therapy administered with curative intent.\n* Have not recovered from reversible toxicity of prior anticancer therapy to \\\u003C Grade 1 or baseline (except toxicities that are not clinically significant or not expected to resolve, including but not limited to, alopecia, fatigue, skin discoloration, or Grade 1 neuropathy).\n* Have received the following anticancer therapy:\n\n  1. Any immunotherapy or other antibody therapy within 28 days prior to the first dose of the study drug.\n  2. A TKI \\\u003C 5 days or 5X the terminal Phase elimination half-lives, whichever is longer, prior to the first dose of TYRA-430.\n  3. Other systemic therapy not listed above \\\u003C 14 days prior to the first dose of the study drug.\n* Participant discontinued a prior anti-FGFR therapy due to significant toxicity, defined as hepatotoxicity ≥ Grade 3 or any Grade 4 toxicity according to CTCAE v5.0.\n* Has a serum phosphorus level \\> upper limit of normal (ULN) during screening that remains \\>ULN despite medical management.\n* History of or current uncontrolled cardiovascular disease.\n* Active, symptomatic, or untreated brain metastases.\n* Have a diagnosis of primary CNS malignancies.\n* Gastrointestinal disorders that will affect oral administration or absorption of TYRA-430.\n* Females who are pregnant, breastfeeding, or planning to become pregnant and males who plan to father a child while enrolled in this study.\n* Any reason that, in the view of investigator, would substantially impair the ability of the participant to comply with study procedures and increase the risk to the participant.\n\nPart B, Cohort 1:\n\n* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n* Prior treatment with pan-FGFR inhibitors or FGFR4-selective inhibitors.\n\nPart B, Cohort 2:\n\n* Histologically confirmed locally advanced\u002Fmetastatic HCC.\n* Histologically confirmed urothelial cancer.",{"count":164,"type":22},[25],"A Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary antitumor activity of TYRA-430 in cancers with FGF\u002FFGFR pathway aberrations, including locally advanced\u002Fmetastatic hepatocellular carcinoma and other advanced solid tumors.",[541,31,542,543,544,545,546,438,547,548,549,550,551,552],"Metastatic Hepatocellular Carcinoma","Solid Tumor, Adult","FGFR Gene Amplification","FGFR Gene Alterations","FGFR3 Gene Alteration","FGFR3 Gene Mutation","FGFR4 Gene Mutation","FGFR4 Gene Fusions","FGF19 Gene Amplification","FGF19 Gene Overexpression","FGFR3 Gene Fusions","Locally Advanced Unresectable Hepatocellular Carcinoma",[554,555,556,557,558,559,560,561,562,563,564,565,566],"Hepatocellular Carcinoma","metastatic cancer","solid tumors","FGF19 gene amplifications","FGFR4 gene alterations","FGFR3 gene alterations","FGF19 gene alterations","FGFR4 gene mutations","FGFR4 gene fusions","FGFR3 gene mutations","FGFR3 gene fusions","FGF19 gene overexpression","locally advanced unresectable cancer",{"date":490,"type":41},{"date":569,"type":41},"2025-04-24",{"date":571,"type":22},"2028-09",{"name":573,"class":70},"Tyra Biosciences, Inc",16,{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":17,"minAge":582,"maxAge":4,"enrollmentInfo":583,"targetDuration":4,"studyType":23,"phases":584,"briefSummary":585,"conditions":586,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":49},"100593112","phase-1-personalized-neoantigen-peptide-vaccines-for-solid-tumors-100593112","NCT07002203","Personalized Neoantigen Peptide Vaccines for Solid Tumors","A Phase Ib Clinical Study of Personalized Neoantigen Peptide Vaccines for Solid Tumors","Inclusion Criteria:\n\n1. Age: 20 years or older.\n2. Language proficiency: Able to read and understand Thai clearly.\n3. Consent: Willing to provide informed consent and sign a participation agreement.\n4. Life expectancy: Estimated to be at least 6 months from the date of consent.\n5. Eligibility from prior research: Must have participated in the SQK01-002A research project and have tumor tissue confirmed as suitable for neoantigen peptide vaccine production.\n6. Performance status: ECOG performance status of 0-2 with stable organ function, no rapid disease progression, or impending organ failure.\n7. Cancer diagnosis: Clinically and pathologically confirmed cancer diagnosis, with supporting radiological evidence.\n8. Cancer stage-specific criteria:\n\n   i. Advanced cancer: Suitable for immune checkpoint inhibitors (ICIs) and shows resistance to prior therapies, with measurable lesions based on mRECIST1.1 criteria.\n\n   ii. Early-stage cancer: High recurrence risk despite prior surgery and\u002For radiotherapy, with no current adjuvant treatment standard.\n9. Laboratory parameters:\n\n   i. Lymphocyte count ≥ 800 cells\u002FμL. ii. Neutrophil count ≥ 1,500 cells\u002FμL. iii. Platelet count ≥ 75,000 cells\u002FμL. iv. AST ≤ 2.5 times the upper limit of normal (ULN). v. ALT ≤ 2.5 times ULN. vi. Total bilirubin ≤ 1.5 times ULN. vii. Serum creatinine ≤ 1.5 times ULN.\n10. Consent to Avoid Pregnancy or Causing Pregnancy Under the Following Criteria i. Female participants not of reproductive age, defined as having undergone a hysterectomy and\u002For bilateral oophorectomy, experiencing continuous menopause for more than 12 months, or being over 60 years of age.\n\nii. Female participants of reproductive age must undergo a pregnancy test and have a confirmed negative result during the preparation phase and before the first day of vaccination. They must also consent to using contraception with an efficacy rate greater than 99%, as recommended by the principal investigator, throughout the study duration, including the preparation phase and follow-up, and up to 120 days after the final treatment.\n\niii. Male participants must consent to using contraception with an efficacy rate greater than 99%, as recommended by the principal investigator, throughout the study duration, including the preparation phase and up to 120 days after the final treatment.\n\nExclusion Criteria:\n\n1. History of hypersensitivity to peptide vaccines or related substances.\n2. Autoimmune disease history.\n3. Previous treatments that significantly suppress or impair immune function.\n4. Refusal of current standard-of-care treatment.\n5. Active brain or central nervous system metastases unless well-controlled with steroids ≤ 10 mg\u002Fday prednisolone.\n6. Presence of more than one active cancer type.\n7. Uncontrolled cardiac conditions, such as unstable angina or advanced heart failure (NYHA Class III\u002FIV).\n\n   i. Participants with pacemakers may be eligible if stabilized for at least 1 month before vaccination.\n8. Receipt of any other vaccines within 28 days before the first neoantigen peptide vaccine.\n9. Participation in another clinical trial.\n10. Use of immunosuppressive drugs or steroids \\> 10 mg\u002Fday prednisolone (except inhaled\u002Fintranasal corticosteroids).\n11. Pre-existing conditions that could compromise the efficacy or safety of the peptide vaccine.\n12. Pregnancy or breastfeeding.","20 Years",{"count":295,"type":22},[25,60],"This clinical trial is studying the safety and efficacy of a personalized cancer vaccine called a neoantigen peptide vaccine in patients with solid tumors. These vaccines are custom-made for each patient using specific mutations (neoantigens) found in their own tumor. The goal is to help the patient's immune system recognize and attack their cancer.\n\nThe study will enroll adult patients (20 years or older) who have solid tumors that meet specific stage-related criteria. These include advanced cancers that are resistant to prior treatments and early-stage cancers at high risk of recurrence, where there are no standard adjuvant therapies available.\n\nParticipants will receive:\n\n* A personalized neoantigen peptide vaccine designed from the mutations in their tumor tissue.\n* Poly-ICLC (Hiltonol), a substance that stimulates the immune system.\n* An anti-PD-1 immune checkpoint inhibitor, a drug that helps the immune system stay active against cancer.\n\nThe vaccine and drugs will be given through multiple injections over several months. Blood samples and imaging will be used to monitor the immune response and how the cancer responds to treatment. Participants will be followed for up to 12 months.\n\nThis study does not include a placebo group. Every participant will receive the personalized vaccine along with the other therapies.\n\nThe primary objectives of this study are:\n\n1. To assess whether the treatment is safe and tolerable.\n2. To evaluate whether this approach helps control the cancer and can be combined with other standard treatments in the future.",[31,587,588,589,590],"Advanced Cancer","Recurrent Cancer","Neoantigen-Specific Immunotherapy","Personalized Cancer Vaccine","2026-07-23",{"date":593,"type":41},"2026-07-24",{"date":595,"type":41},"2024-03-01",{"date":597,"type":22},"2027-08",{"name":599,"class":70},"Seqker Biosciences, Inc.",{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":4,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":17,"minAge":607,"maxAge":4,"enrollmentInfo":608,"targetDuration":4,"studyType":23,"phases":610,"briefSummary":611,"conditions":612,"keywords":616,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":640,"startDateStruct":641,"completionDateStruct":643,"leadSponsor":645,"locationsCount":647},"100477963","phase-2-a-study-to-assess-the-efficacy-and-safety-of-fore8394-in-participants-with-cancer-harboring-braf-alterations-100477963","NCT05503797","A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations","A Phase 2 Master Protocol to Assess the Efficacy and Safety of FORE8394, an Inhibitor of BRAF Class 1 and Class 2 Alterations, in Participants With Cancer Harboring BRAF Alterations","Inclusion Criteria\n\nSubprotocol A:\n\n1. Male and female, ≥8 years of age, and weighing ≥25 kg.\n2. Histologic diagnosis of a solid tumor or primary CNS tumor.\n3. Documentation of BRAF gene fusion in tumor and\u002For blood detected by an analytically validated test by DNA sequencing or RNA (transcriptome) sequencing.\n4. Have an archival tissue sample available meeting protocol requirements.\n5. Consent to provide scan(s) prior to baseline to assess change in tumor trajectory.\n6. Received all available standard therapy, is intolerant to available therapies, or the investigator has determined that treatment with standard therapy is not appropriate.\n7. All adverse events related to prior therapies (chemotherapy; radiotherapy; surgery) must have resolved to Grade 1 or baseline.\n\nSubprotocol B:\n\n1. Male and female, ≥8 years of age, and weighing ≥25 kg.\n2. Histological diagnosis of a primary CNS tumor, including but not limited to the following:\n\n   1. Adults (≥18 years) with Grade 1-4 glioma or glioneuronal tumor (including glioblastoma, anaplastic astrocytoma, high grade astrocytoma with piloid features, pilocytic astrocytoma, gliosarcoma, anaplastic pleomorphic xanthoastrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, not otherwise specified \\[NOS\\], ganglioglioma, or recurrent LGG). OR\n   2. Pediatric patients (8-17 years of age) with a Grade 3 or 4 glioma or glioneuronal tumor, including those with a prior, histologically confirmed, diagnosis of a low-grade glioma or glioneuronal tumor and now have radiographic or histopathological findings consistent with WHO \\[2021\\] Grade 3 or 4 primary CNS tumor.\n   3. Participants must have unresectable, locally advanced or metastatic disease that:\n\n   i. Had prior treatment with radiotherapy and\u002For first-line chemotherapy or concurrent chemoradiation therapy OR\n   * Note: Participants who have a WHO Grade 3 or 4 glioma for whom chemotherapy and\u002For radiotherapy is not considered standard of care may remain eligible for the study.\n\n   ii. Is intolerant to available therapies OR iii. The investigator has determined that treatment with standard therapy is not appropriate.\n3. Documented BRAF V600E mutation in tumor and\u002For liquid biopsy detected by an analytically validated test at CLIA or CLIA-equivalent laboratory approved by sponsor or sponsor-designated central test.\n4. An archival tissue sample available meeting protocol requirements, or fresh biopsy is required if the archival sample is not available for retrospective confirmation test.\n5. Consent to provide scan(s) prior to baseline to assess change in tumor trajectory.\n6. Measurable disease based upon specified response criteria, as determined by the radiographic BICR.\n7. All adverse events related to prior therapies (eg, chemotherapy, radiotherapy, surgery) must have resolved to Grade 1 or baseline.\n8. Participants who are receiving corticosteroid treatment must be on a stable or decreasing dose of ≤8 mg\u002Fday of dexamethasone or equivalent corticosteroid treatment for 7 days prior to first dose of study treatments.\n\nSubprotocol C:\n\n1. Male and female, ≥8 years of age, and weighing ≥25 kg.\n2. Histologic diagnosis of a rare BRAF V600E-mutated solid tumor that is unresectable, locally advanced or metastatic.\n3. Measurable disease on CT, MRI, or physical exam\n4. Documented BRAF V600E mutation in tumor and\u002For liquid biopsy detected by an analytically validated test.\n5. Have an archival tissue sample available meeting protocol requirements.\n6. Consent to provide scan(s) prior to baseline to assess change in tumor trajectory\n7. Received all available standard therapy, is intolerant to available therapies, or the investigator has determined that treatment with standard therapy is not appropriate.\n\nSubprotocol D:\n\n1. Male and female, ≥8 years of age, and weighing ≥25 kg.\n2. Histologic diagnosis of a solid tumor harboring a BRAF V600E mutation and not eligible for other subprotocols.\n3. Measurable disease on CT, MRI, or physical exam.\n4. Evidence of BRAF V600E mutation in tumor and\u002For blood detected by genomic tests.\n5. Consent to provide a tumor biopsy.\n6. Willingness to comply with the ECG substudy procedures.\n7. All adverse events related to prior therapies (chemotherapy; radiotherapy; surgery) must have resolved to Grade 1 or baseline.\n\nExclusion Criteria:\n\nSubprotocol A:\n\n1. Prior treatment with RAF\u002FBRAF inhibitors active for Class 2 BRAF alterations for advanced unresectable or metastatic disease.\n2. Prior treatment with a MEK inhibitor.\n3. Tyrosine kinase inhibitor(s) and\u002For targeted therapies are allowed (other than BRAF\u002FMAPK pathway inhibitors per Exclusion Criteria 3 and 4) and will be restricted to no more than the number of lines of therapy that are consistent with standard treatment guidelines.\n4. Malignancy with co-occurring activating RAS mutation(s) at any time.\n5. Uncontrolled intercurrent illness that would limit compliance with study requirements.\n6. HIV infection with exceptions; discuss with treating physician.\n7. Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral plixorafenib or cobicistat (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, and small bowel resection).\n8. Grade ≥2 changes in AST, ALT, GGT, or bilirubin attributed to prior immune checkpoint inhibitor treatment are exclusionary, even if resolved.\n\nSubprotocol B:\n\n1. Prior treatment with BRAF, ERK, and\u002For MEK inhibitor(s).\n2. Known or suspected neurofibromatosis-1 (NF-1) and\u002For RAS related gene alterations.\n3. Uncontrolled intercurrent illness that would limit compliance with study requirements.\n4. Active infection requiring systemic therapy.\n5. HIV infection with exceptions; discuss with treating physician.\n6. Have impairment of GI function or GI disease that may significantly alter the absorption of oral plixorafenib (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).\n7. Grade ≥ 2 changes in AST, ALT, gamma-glutamyl transaminase (GGT), or bilirubin attributed to prior immune checkpoint inhibitor treatment are exclusionary, even if resolved.\n\nSubprotocol C:\n\n1. Diagnosis of colorectal adenocarcinoma or pancreatic ductal adenocarcinoma (neuroendocrine or acinar tumors are eligible).\n2. Diagnosis of BRAF V600E-mutated cutaneous melanoma, papillary thyroid cancer, or NSCLC.\n3. Participant has CNS metastases.\n4. Prior treatment with BRAF, ERK, and\u002For MEK inhibitor(s), unless otherwise specified for specific tumor types (i.e. low grade serous or borderline ovarian cancer).\n5. Known or suspected neurofibromatosis-1 (NF-1) and\u002For RAS related gene alterations.\n6. Participants with prostate, breast, or gynecologic cancers with known activating mutations that lead to constitutive hormone receptor activation (AR-V7, ESR1).\n7. Uncontrolled intercurrent illness that would limit compliance with study requirements.\n8. Active infection requiring systemic therapy.\n9. HIV infection with exceptions; discuss with treating physician.\n\nSubprotocol D:\n\n1. Known or suspected neurofibromatosis-1 (NF-1) and\u002For RAS related gene alterations or other co-occurring driver mutations.\n2. Participant has a non-CNS solid tumor with CNS metastases.\n3. Uncontrolled intercurrent illness that would limit compliance with study requirements.\n4. Active infection requiring systemic therapy.\n5. HIV infection with exceptions; discuss with treating physician.\n6. Use or anticipate the need for medications with known risk for QT-prolonging potential and Torsades de Pointes.\n7. History of acute or chronic cardiovascular disease or surgery, hypertension, with systolic blood pressure \\>160mm HG, history of QTc abnormalities, or clinical significantly ECG abnormalities (for participants in the ECG substudy).","8 Years",{"count":609,"type":22},254,[60],"The objective of this Master Protocol is to evaluate the efficacy and safety of plixorafenib in participants with BRAF altered (BRAF V600E or BRAF fusions) locally advanced or metastatic solid tumors, or recurrent or progressive primary central nervous system (CNS) tumors, including rare BRAF V600E-mutated solid tumors, including anaplastic thyroid, ovarian, cholangiocarcinoma or other rare cancers.",[613,614,615,31],"Cancer Harboring BRAF Alterations","HGG","LGG",[617,618,619,620,621,622,623,614,615,624,625,626,627,628,629,630,631,632,633,634,635,636,637,638,639],"BRAF alterations","BRAF Fusions","BRAF V600E","BRAF Class 1","BRAF Class 2","High grade glioma","low grade glioma","Solid tumors","Biliary tract cancer","Ovarian cancer","Fallopian tube cancer","Primary peritoneal cancer","Anaplastic thyroid cancer","Cholangiocarcinoma","Bladder cancer","Uterine cancer","Hepatocellular carcinoma","Gastrointestinal stromal tumor (GIST)","Breast cancer","Children","Pediatric","Adolescent","Young adult",{"date":494,"type":41},{"date":642,"type":41},"2023-02-21",{"date":644,"type":22},"2028-12-28",{"name":646,"class":70},"Fore Biotherapeutics",70,{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":4,"eligibilityCriteria":654,"healthyVolunteers":12,"sex":17,"minAge":655,"maxAge":656,"enrollmentInfo":657,"targetDuration":4,"studyType":23,"phases":658,"briefSummary":659,"conditions":660,"keywords":662,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":665,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":670,"locationsCount":672},"100406285","phase-2-a-study-to-evaluate-the-safety-and-pharmacokinetics-of-eflapegrastim-in-pediatric-participants-with-solid-tumors-or-lymphomas-and-treated-with-myelosuppressive-chemotherapy-100406285","NCT04570423","A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy","A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy","Inclusion Criteria:\n\n1. Participant must have a pathologic\u002Fhistologic confirmed newly diagnosed\u002Frelapsed\u002Frecurrent solid tumor or lymphoma without bone marrow involvement.\n2. Participant must be a candidate to receive myelosuppressive chemotherapy, with a febrile neutropenia rate of at least 20% as outlined in the National Comprehensive Cancer Network (NCCN) guidelines.\n3. Participant has adequate hematological, renal, and hepatic function.\n4. Participant must have an echocardiogram (ECHO) or multigated acquisition (MUGA) within 14 days of Screening if receiving a cardiotoxic therapy and have a cardiac ejection fraction of \\>50%.\n5. Participant must have a lumbar puncture, if clinically indicated, to rule out central nervous system (CNS) involvement within 14 days of study entry.\n6. Participant has a Karnofsky performance level ≥50% for patients ≥16 years of age or a Lansky performance level ≥50 for children \\\u003C16 years of age.\n\nExclusion Criteria:\n\n1. Participant has an uncontrollable infection, has an underlying medical condition, and\u002For another serious illness that would impair the ability of the participant to receive protocol-specified treatment.\n2. Participant has had previous exposure to filgrastim (within 7 days), pegfilgrastim (within 14 days), or other granulocyte colony stimulating factor (G-CSF) products in clinical development within 2 weeks prior to the administration of study drug (eflapegrastim)\n3. Participant requires concurrent radiation therapy specifically in Cycle 1.\n4. Participant has had prior bone marrow or hematopoietic stem cell transplant and\u002For has concurrent bone marrow involvement in their malignancy, including leukemia.\n5. Participant has had spinal radiation therapy within 30 days prior to study enrollment.\n6. Participant has used any investigational drugs, biologics or devices within 30 days prior to study treatment or plans to use any of these during the study.\n7. Participant has a known sensitivity or previous reactions to any of the G-CSF products.\n8. Participant with active CNS disease.\n9. Participant has not recovered from previous treatment adverse events to ≤Grade 1.","1 Month","17 Years",{"count":21,"type":22},[60],"The purpose of this study is to evaluate the safety and pharmacokinetics of eflapegrastim in pediatric participants with solid tumors or lymphoma and treated with myelosuppressive chemotherapy.",[31,661],"Lymphoma",[663,31,664],"Lymphomas","Chemotherapy",{"date":593,"type":41},{"date":667,"type":41},"2021-05-20",{"date":669,"type":22},"2027-10",{"name":671,"class":70},"Spectrum Pharmaceuticals, Inc",5,{"id":674,"slug":675,"hasResults":12,"nctId":676,"briefTitle":677,"officialTitle":678,"acronym":4,"eligibilityCriteria":679,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":680,"targetDuration":4,"studyType":23,"phases":681,"briefSummary":682,"conditions":683,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":684,"lastUpdatePostDateStruct":685,"startDateStruct":686,"completionDateStruct":687,"leadSponsor":689,"locationsCount":4},"100648868","evaluate-the-diagnostic-efficacy-and-safety-of-inr-202-petct-imaging-in-participants-with-advanced-solid-tumors-100648868","NCT07727317","Evaluate the Diagnostic Efficacy and Safety of INR 202 PET\u002FCT Imaging in Participants With Advanced Solid Tumors","A Clinical Study to Evaluate the Diagnostic Efficacy and Safety of INR 202 PET\u002FCT Imaging in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. ECOG performance status of 0 or 1.\n3. Advanced solid tumors.\n4. Adequate organ functions.\n5. Life expectancy ≥6 months.\n6. Agreement to use contraceptive measures from the date of informed consent signing until 3 months after administration of INR202, and to avoid sperm or egg donation during this period.\n7. The participant (or legal guardian, where applicable) is fully informed of the purpose and procedures of the study, is able to understand the information provided, and voluntarily signs the informed consent form.\n\nExclusion Criteria:\n\n1. Unable to complete imaging examinations as required by the study protocol, in the investigator's judgement.\n2. With a history of ≥2 malignancies within 5 years prior to administration of INR202, except for adequately treated non-metastatic thyroid cancer, basal cell carcinoma of the skin, superficial squamous cell carcinoma of the skin, or superficial bladder cancer.\n3. Known hypersensitivity to the active ingredient of INR202 or any of its components.\n4. Any medical condition or other situation that, in the investigator's judgement, may affect safety, compliance, or study outcomes.",{"count":127,"type":22},[425],"This is a prospective, single-center, open-label clinical study comparing the imaging performance of INR202 PET\u002FCT versus 18F-FDG PET\u002FCT in participants with advanced solid tumors.",[31],"2026-07-22",{"date":494,"type":41},{"date":230,"type":22},{"date":688,"type":22},"2028-07",{"name":690,"class":274},"Shanghai Zhongshan Hospital"]