[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Innovent Biologics (Suzhou) Co. Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":544},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,45,0,25,[9,44,67,88,110,131,153,174,197,216,237,259,279,299,322,341,363,384,405,425,444,463,482,504,523],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100651756","phase-1-clinical-trials-of-ibi3040-in-healthy-participants-and-overweight-or-obese-participants-100651756",false,"NCT07765160","Clinical Trials of IBI3040 in Healthy Participants and Overweight or Obese Participants","A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Characteristics of a Single Subcutaneous Administration of IBI3040 in Healthy Participants and Multiple Subcutaneous Administrations in Overweight or Obese Participants","Inclusion Criteria:\n\nAll participants in Part A (SAD) and Part B (MAD) must meet inclusion criteria 1-3:\n\n* 1.The age at the time of informed consent should be between 18 and 65 years old (including both values), and there is no gender restriction.\n* 2.Female participants who are fertile and male participants whose partners are fertile must agree to use the contraceptive methods specified in the protocol during the study period and within 90 days after the last administration. The pregnancy test results of female participants with fertility before randomization must be negative. Female participants should not breastfeed. Male\u002Ffemale participants must be willing to avoid donating sperm\u002Feggs during the study period and within 90 days after the last administration.\n* 3\\. Be able to understand the procedures and methods of this research, be willing to strictly follow the clinical trial protocol to complete this trial, and voluntarily sign the informed consent form.\n\nParticipants of Part A (SAD) also need to meet inclusion criteria 4-6:\n\n* 4\\. Participants who were determined by the researchers to be normal or abnormal based on the results of various examinations such as medical history, vital signs, physical examination, 12-lead electrocardiogram, laboratory tests, infectious disease screening, chest X-ray, and abdominal color Doppler ultrasound, but were determined by the researchers to have no clinical significance.\n* 5\\. During screening, 20 kg\u002Fm ² ≤BMI \\\u003C28 kg\u002Fm ²;\n* 6\\. When screening, the standard weight should be ≥50 kg\n\nParticipants of Part B (MAD) also need to meet inclusion criteria 7-8:\n\n* 7\\. During screening, 24 kg\u002Fm2 ≤BMI ≤40 kg\u002Fm2;\n* 8\\. The standard weight change within 3 months prior to screening should be no more than 5kg (reported by the participants themselves).\n\nExclusion Criteria:\n\nAll participants in Part A (SAD) and Part B (MAD) who meet any one of the exclusion criteria 1-17 cannot be included in the corresponding stage of the study:\n\n* 1.Participants may be allergic to any component of the investigational drug, GLP-1 or Amylin receptor agonists (see Appendix 3 for details), or have used GLP-1 or Amylin receptor agonists within 3 months prior to screening;\n* 2\\. A history of diabetes, or a glycated hemoglobin level of ≥6.5% during the screening period, or a fasting blood glucose level of ≥7.0 mmol\u002FL;\n* 3\\. Previous history of thyroid C-cell carcinoma, multiple endocrine adenomatosis (MEN) 2A or 2B, or related family history, or calcitonin ≥20 ng\u002FL at screening;\n* 4\\. A history of acute or chronic pancreatitis in the past, or amylase or lipase \\>1.5× upper limit of the normal range (ULN) at the time of screening;\n* 5\\. Alanine aminotransferase \\>1.5×ULN during the screening period; Or aspartate aminotransferase \\>1.5×ULN; Or total bilirubin \\>1.5×ULN;\n* 6\\. During the screening period, the hepatitis B surface antigen is positive, or the hepatitis C antibody is positive, or the syphilis helix specific antibody is positive, or the HIV antibody is positive;\n* 7\\. Abnormal 12-lead electrocardiogram (ECG) during the screening period and judged by the researcher as having clinical significance, or ECG QTcF \\>450 ms, or heart rate \\\u003C60 beats per minute or \\>100 beats per minute;\n* 8\\. Having a history of suicidal behavior, or being considered to have a significant suicide risk at present, or having a PHQ (Depression Screening Scale) score of ≥15 at the time of screening, or being classified as category 4 or 5 on the C-SSRS (Columbia Suicide Severity Scale) at the time of screening, or choosing \"yes\" in suicidal behavior or suicidal ideation;\n* 9\\. Use of prescription and over-the-counter drugs within 2 weeks before screening or within 5 half-lives (excluding topical eye\u002Fnasal drops and creams without systemic exposure risk);\n* 10\\. Have participated in any clinical trials of drugs (or within five half-lives) or medical devices within three months prior to screening, or plan to participate in clinical trials of other drugs or medical devices during the trial period;\n* 11\\. Those who consumed an average of more than 2 units of alcohol per day in the three months prior to screening (1 unit of alcohol ≈360 mL of beer with an alcohol content of 5% or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine with an alcohol content of 12%), or those who were unable to quit drinking during the trial period, or those with a positive breath test for alcohol;\n* 12\\. Smoking more than 5 cigarettes per day within the 3 months prior to screening;\n* 13\\. Those who have a history of drug abuse within the five years prior to screening, or have used drugs within the three months prior to screening, or have a positive urine drug screening result;\n* 14\\. Blood donation and\u002For blood loss within 3 months prior to screening ≥450 mL, or having undergone bone marrow donation, blood transfusion or severe blood loss, or having hemoglobinopathy, hemolytic anemia, sickle cell anemia, or hemoglobin \\\u003C120 g\u002FL (for men) or \\\u003C110 g\u002FL (for women);\n* 15\\. Inability to tolerate venipuncture for blood collection or fainting at the sight of needles and blood;\n* 16\\. Those whose injection site assessment is considered abnormal by the researchers;\n* 17\\. The researcher believes that there are other factors that are not suitable for participating in this trial.\n\nParticipants in Part A (SAD) cannot be included in the study if they meet the following exclusion criteria:\n\n\\- 18. During the screening period, the systolic blood pressure is less than 90mmHg or ≥140mmHg, or the diastolic blood pressure is less than 50 mmHg or ≥90mmHg, or the pulse rate is less than 60 beats per minute or \\>100 beats per minute.\n\nParticipants in Part B (MAD) who meet any one of the exclusion criteria 19-25 cannot be included in the study:\n\n* 19\\. The following diseases (including but not limited to gastrointestinal, kidney, liver, nervous, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases) with clinical findings indicating clinical significance within 12 months prior to screening;\n* 20\\. A history of life-threatening diseases (excluding basal cell skin cancer or squamous cell skin cancer) within the five years prior to screening;\n* 21\\. Previous researchers have considered clinically significant gastric emptying abnormalities (for example, severe gastroparesis or gastric outlet obstruction), who have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery, or have been taking drugs that directly affect gastrointestinal motility for a long time;\n* 22\\. During the screening period, systolic blood pressure is less than 90 mmHg or ≥160mmHg, or diastolic blood pressure is less than 50 mmHg or ≥100mmHg, or pulse rate is less than 60 beats per minute or \\>100 beats per minute.\n* 23\\. For drugs that have been used or are currently being used within the three months prior to screening and may cause significant standard weight gain, including but not limited to: tricyclic antidepressants, psychotropic drugs or sedatives (such as imipramine, amitriptyline, mirtazapine, paroxetine, phenylhydrazine, chlorpromazine, thiridazine, clozapine, olanzapine, valproic acid, valproic acid derivatives, lithium salts);\n* 24\\. Having used weight-loss drugs or alternative therapies within the three months prior to screening, including but not limited to: GLP-1 or Amylin receptor agonists, orlistat, sibutramine hydrochloride, phenylpropanolamine, chlorphenimidole, butylamine, clocaserin hydrochloride, fentamine, fentamine\u002Ftopiramate mixture, anferylene and naltrexone\u002Fbupropion mixture.\n* 25\\. Thyroid tumors or thyroid nodules with a Thyroid Imaging Reporting and Data System (TI-RADS) grade of ≥4 were present during screening.",true,"ALL","18 Years","65 Years",{"count":22,"type":23},96,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","Clinical trials of IBI3040 with single-dose administration in healthy participants and multiple-dose administration in overweight or obese participants.",[29,30],"Healthy Participants","Overweight or Obese Participants","NOT_YET_RECRUITING","2026-08-11",{"date":34,"type":35},"2026-08-14","ACTUAL",{"date":37,"type":23},"2026-08-30",{"date":39,"type":23},"2027-12-10",{"name":41,"class":42},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":24,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":43},"100613336","phase-4-a-study-of-teprotumumab-n01-in-subjects-with-active-thyroid-eye-disease-100613336","NCT07265258","A Study of Teprotumumab N01 in Subjects With Active Thyroid Eye Disease","A Multicenter, Randomized, Open-Label, Active-Controlled Phase IV Clinical Study to Evaluate the Efficacy and Safety of Teprotumumab N01 in the Treatment of Active Thyroid Eye Disease","Inclusion Criteria:\n\nKey Inclusion Criteria:\n\n1. Written informed consent.\n2. Male or female subject between the ages of 18 and 80 years at screening.\n3. Weight between 45 kg and 100 kg.\n4. Moderate-to-severe active TED:\n\n   * CAS ≥ 3 in the study eye at screening and baseline;\n   * Usually associated with at least two of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal, and\u002For inconstant or constant diplopia;\n   * ≤ 12 months since the onset of active TED symptoms according to subjects' chief complaint or medical record at screening;\n5. Exophthalmos ≥ 16 mm in the study eye at baseline.\n6. Infertile female participants or fertile female participants with negative blood pregnancy test results during the screening period and agree to take contraceptive measures from screening to 120 days after the last dose; male participants should agree to use contraceptive measures from screening to 120 days after the last dose.\n\nExclusion Criteria:\n\nKey Exclusion Criteria:\n\nParticipants to be excluded (Participants meeting any of the following criteria will be regarded as ineligible):\n\n1. The CAS of the study eye at baseline is reduced by ≥ 2 points compared with that at screening, or the proptosis of the study eye at baseline is reduced by ≥ 2 mm compared with that at screening;\n2. Participants previously diagnosed with dysthyroid optic neuropathy (DON), or with DON as determined by the investigator at screening;\n3. Patients with corneal ulcers that are not relieved after treatment at the investigator's discretion;\n4. Scheduled orbital radiotherapy at any time before baseline or during the study, or surgical treatment for TED, including orbital decompression, strabismus surgery, and eyelid surgery;\n5. Participants with poorly controlled thyroid function, defined as free triiodothyronine (FT3) or free thyroxine (FT4) deviating from the normal reference range of the local laboratory by more than 50% at screening;\n6. Any other pre-existing disease, metabolic disorder, or physical examination or clinical laboratory abnormality that leads to a reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug, affects the interpretation of study results, or places the participant at high risk of treatment complications;\n7. History of tinnitus or other hearing impairment in either ear during the screening period; or abnormal pure tone audiometry results (defined as an average bone conduction hearing threshold of ≥ 25 dB at 0.5, 1, 2, and 4 kHz, or a bone conduction hearing threshold of ≥ 40 dB at any frequency);\n8. Poorly controlled diabetes mellitus (defined as glycosylated hemoglobin ≥ 8.0% at screening);\n9. Cumulative dose of glucocorticoids used to treat TED ≥ 1 g methylprednisolone equivalents at any time before baseline;\n10. Oral or intravenous glucocorticoids within 30 days prior to screening;\n11. Peribulbar\u002Fperiorbital injection of glucocorticoids within 90 days prior to screening;\n12. Oral or intravenous administration of any other non-steroidal immunosuppressants within 90 days prior to screening;\n13. Use of glucocorticoid eye drops\u002Fointments or use of non-steroidal immunosuppressant eye drops within 30 days prior to screening;\n14. Received TEPEZZA or Teprotumumab N01 Injection at any time before screening;\n15. Received CD20 antibody or interleukin-6 receptor (IL-6R) antibody at any time before screening;\n16. Have received any other TED therapeutic drugs under development (including but not limited to biologics targeting IGF-1R, FcRn, and TSHR) at any time before screening;\n17. Use of any other monoclonal antibody within 90 days prior to screening;\n18. Female participants in pregnancy or lactation.","80 Years",{"count":53,"type":23},92,[55],"PHASE4","This is a multicenter, randomized, open-label, active-controlled Phase IV clinical trial in participants with active thyroid eye disease (TED). Approximately 92 eligible participants will be randomized to the teprotumumab N01 group and the intravenous glucocorticoid (IVGC) group in a 1:1 ratio on Day 1. The randomization stratification factor is diplopia at baseline (Gorman diplopia score ≥1 vs. Gorman diplopia score = 0).",[58],"Thyroid Eye Disease","RECRUITING",{"date":61,"type":35},"2026-08-13",{"date":63,"type":35},"2026-07-30",{"date":65,"type":23},"2028-12-30",{"name":41,"class":42},{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":24,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":43},"100651812","phase-2-a-open-label-phase-in-participants-with-multiple-myeloma-100651812","NCT07764861","A Open-Label Phase in Participants With Multiple Myeloma","A Multi-Center, Open-Label Phase II Study of IBI3003 in Combination With Anti-CD38 Monoclonal Antibody in Participants With Multiple Myeloma","Inclusion Criteria:\n\n* 1\\. Aged at least 18 years old;\n* 2\\. Initial diagnosis of multiple myeloma documented according to International Myeloma Working Group (IMWG) diagnostic criteria.Multiple myeloma is defined as clonal bone marrow plasma cells ≥ 10% or biopsy-proven bony or extramedullary plasmacytoma, and any one or more of the following myeloma-defining events: • Evidence of end-organ damage attributable to the underlying plasma cell proliferative disorder, including the following: Hypercalcemia: serum calcium \\> 0.25 mmol\u002FL (\\> 1 mg\u002FdL) above the upper limit of normal or corrected serum calcium \\> 2.75 mmol\u002FL (\\> 11 mg\u002FdL); renal insufficiency: creatinine clearance \\\u003C 40 mL\u002Fmin or serum creatinine \\> 177 μmol\u002FL (\\> 2 mg\u002FdL); anemia: hemoglobin value \\> 2 g\u002FdL below the lower limit of normal or hemoglobin value \\\u003C 10 g\u002FdL; bone lesions: one or more osteolytic lesions on skeletal radiographs, computed tomography (CT), or positron emission tomography (PET)-CT.\n\n  • Any one or more of the following biomarkers of malignancy: Clonal bone marrow plasma cell percentage ≥ 60%; involved-to-uninvolved serum free light chain ratio ≥ 100 \\[involved serum free light chain (FLC) level must be ≥ 100 mg\u002FL\\]; \\> 1 focal lesion (at least 5 mm in size) on magnetic resonance imaging (MRI) examination.\n* 3.Safety run-in stage: Relapsed or refractory measurable multiple myeloma who have previously received ≥ 1 line of anti-myeloma therapy (including treatment with at least one proteasome inhibitor and one immunomodulatory drug), and the participant must be relapsed or refractory to the most recent treatment.Participants previously exposed to anti-CD38 monoclonal antibodies may also be enrolled (a 90-day washout period is required).\n\nNote: Refractory to antimyeloma therapy requires failure to achieve minimal response (receipt of at least 2 complete cycles) or progression during treatment (no requirement for number of treatment cycles), or progression within 60 days of last treatment.\n\nCohort 1: Participants with newly diagnosed multiple myeloma who are ineligible for or refusing ASCT.\n\nCohort 2: Participants with newly diagnosed multiple myeloma who are eligible for and interested in ASCT.\n\n* 4\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* 5\\. At least one of the following measurable disease indicators: • Serum M protein \\>= 5 g\u002FL (for IgA and IgD subtypes, quantitative immunoglobulin measurement can be used to replace M protein); • Urine M protein \\>= 200mg\u002F24h; • FLC test: involved FLC level \\>= 100 mg\u002FL and abnormal FLC ratio (\\\u003C 0.26 or \\> 1.65).\n\nExclusion Criteria:\n\n* 1\\. All subjects have previously received any treatment targeting BCMA and any treatment targeting GPRC5D.Participants who have received either a BCMA-directed or GPRC5D-directed therapy are allowed.\n* 2\\. Known active central nervous system (Central Nervous System, CNS) involvement or clinical symptoms of meningeal involvement of multiple myeloma.\n* 3\\. Has amyloidosis, plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, solitary plasmacytoma, or smoldering (asymptomatic) multiple myeloma as defined by IMWG criteria.\n* 4\\. Patients with spinal cord compression resulting in limited self-care at present or within 6 months before signing the informed consent form, or expected to result in such restrictions during study participation.\n* 5\\. History of primary immunodeficiency.\n* 6\\. Other malignant tumors (except for cured basal cell or squamous cell skin cancer, superficial bladder cancer, prostatic intraepithelial neoplasia, cervical carcinoma in situ, or other non-invasive or indolent malignant tumors) at the time of enrollment or within 3 years prior to enrollment.\n* 7\\. Received allogeneic hematopoietic stem cell transplantation within 6 months prior to the first dose of study drug, or received autologous stem cell transplantation within 3 months prior to the first dose of study drug.\n* 8\\. History of organ transplantation.\n* 9\\. Active graft-versus-host disease.",{"count":75,"type":23},120,[77],"PHASE2","This is an open-label, multi-center phase II study of IBI3003 in combination with anti-CD38 monoclonal antibody in adult subjects with multiple myeloma. This study includes a safety run-in period and 2 cohorts (Cohorts 1 and 2).In the safety run-in period, subjects with measurable relapsed or refractory multiple myeloma who had previously received at least 1 line of systemic anti-myeloma therapy and had a history of dual drug exposure (at least one proteasome inhibitor and one immunomodulatory agent) were enrolled, mainly to evaluate the safety and tolerability of IBI3003 in combination with anti-CD38 monoclonal antibody and to determine the recommended phase 2 dose of IBI3003 in combination with anti-CD38 monoclonal antibody.Cohort 1 mainly enrolls newly diagnosed MM(Multiple myeloma)patients who are ineligible for or refusing ASCT(Autologous Stem Cell Transplantation), and Cohort 2 enrolls newly diagnosed MM patients who are eligible for and willing to undergo ASCT. The 24-week MRD negative rate of IBI3003 in combination with anti-CD38 monoclonal antibody in the participant population is mainly evaluated.",[80],"Multiple Myeloma","2026-08-10",{"date":34,"type":35},{"date":84,"type":23},"2026-08-15",{"date":86,"type":23},"2031-06-30",{"name":41,"class":42},{"id":89,"slug":90,"hasResults":12,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":24,"phases":97,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},"100648583","ibi363-combined-with-bevacizumab-for-advanced-colorectal-cancer-100648583","NCT07722494","IBI363 Combined With Bevacizumab for Advanced Colorectal Cancer","A Randomized, Open-label, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of IBI363 in Combination With Bevacizumab Versus Investigator's Choice of Therapy in Participants With Advanced Colorectal Cancer Who Have Failed or Are Intolerant to Standard Care of Therapy","Inclusion Criteria\n\n1. Has signed the written Informed Consent Form and is capable of complying with the visit schedules and relevant procedures specified in the protocol.\n2. Aged ≥ 18 years, with no restriction on gender.\n3. Histologically or cytologically confirmed unresectable metastatic colorectal adenocarcinoma.\n4. Has experienced treatment failure or intolerance to prior systemic standard therapies administered for metastatic disease, with failure or intolerance occurring on the most recent line of systemic therapy.\n5. Has at least one measurable lesion per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).\n6. Colorectal cancer characterized by proficient mismatch repair (pMMR), or microsatellite stable (MSS) status.\n7. Confirmed adequate bone marrow and organ function at screening.\n8. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.\n9. Expected survival duration ≥ 3 months.\n10. Female subjects of childbearing potential, or male subjects whose partners are females of childbearing potential, agree to strictly use effective contraceptive measures throughout the treatment period and for 6 months after treatment completion. Lactating female subjects agree to completely refrain from breastfeeding throughout the treatment period and for 6 months after treatment completion.\n\nExclusion Criteria\n\n1. Prior disease progression, treatment intolerance, or contraindication to all three agents: fruquintinib, trifluridine\u002Ftipiracil (TAS-102), and regorafenib.\n2. Prior receipt of immunotherapy targeting anti-PD-(L)-1 or PD-L2 in the metastatic setting.\n3. History of severe toxicities related to anti-PD-(L)-1 immunotherapy or anti-VEGF therapy that necessitated permanent discontinuation of treatment, or contraindication to any of the above agents.\n4. Prior administration of interleukin (IL)-2 or IL-15 cytokines.\n5. Absence of documented clear evidence to confirm left- or right-sided primary colorectal tumor; or presence of primary colorectal lesions on both sides.\n6. Radiologically confirmed active or symptomatic central nervous system (CNS) metastases, including intraparenchymal brain, leptomeningeal, and spinal cord metastases.\n7. Subjects with unresolved adverse events attributable to any prior anti-tumor therapy that have not recovered to NCI CTCAE (Version 5.0) Grade 0 or Grade 1, or returned to baseline levels prior to randomization. Exceptions include alopecia, fatigue, hypothyroidism managed solely with thyroid hormone replacement, hyperglycemia controlled exclusively by insulin replacement, electrolyte abnormalities manageable with symptomatic treatment only, and other conditions judged by the Investigator to pose no safety risks with study drug administration.\n8. History of another malignant tumor within 5 years before the first dose of study drug. The following malignancies are allowed if curatively resected, with no current evidence of residual or recurrent disease and an extremely low recurrence risk: carcinoma in situ, cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, lentigo maligna, localized prostate cancer, papillary thyroid carcinoma, non-invasive papillary urothelial carcinoma.\n9. Active autoimmune disease requiring systemic therapy (e.g., disease-modifying anti-rheumatic drugs, corticosteroids, immunosuppressants) within 2 years prior to the first study drug dose. Replacement therapies (e.g., thyroxine, insulin, physiological corticosteroids for adrenal or pituitary insufficiency) shall not be regarded as systemic immunosuppressive treatment.\n10. Prior history of interstitial lung disease, pulmonary fibrosis, pneumoconiosis, drug-induced pneumonitis, radiation pneumonitis, or other pulmonary disorders requiring corticosteroids or other therapeutic intervention.\n11. Active uncontrolled bleeding or known bleeding diathesis;\n12. Known history of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation.\n13. Subjects with known or suspected hypersensitivity to the study drug or any of its excipients.\n14. Female subjects who are pregnant, breastfeeding, or planning to conceive before study drug administration, during treatment, or within 6 months after the last study drug dose.\n15. Any past medical condition, prior treatment, or abnormal laboratory findings, or current clinical evidence that, in the Investigator's judgment, may compromise subject safety, interfere with the acquisition of informed consent, impair subject compliance, or confound the safety evaluation of the study drug; subjects with psychiatric disorders, altered mental status, or substance abuse that impairs the ability to comprehend the informed consent process and\u002For complete required study assessments; subjects whom the Investigator determines will fail to comply with protocol requirements for known or foreseeable reasons.",{"count":96,"type":23},550,[98],"PHASE3","This is an open-label, multicenter Phase 3 study to evaluate the safety and tolerability of IBI363 plus bevacizumab in patients with advanced colorectal cancer refractory or intolerant to standard-of-care therapy",[101],"Colorectal Cancer","2026-08-07",{"date":81,"type":35},{"date":105,"type":35},"2026-07-31",{"date":107,"type":23},"2030-12-31",{"name":41,"class":42},2,{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":24,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":43},"100650986","a-study-to-evaluate-the-equivalence-of-ibi3027-and-dupilumab-injection-in-participants-with-moderate-to-severe-atopic-dermatitis-100650986","NCT07754786","A Study to Evaluate the Equivalence of IBI3027 and Dupilumab Injection in Participants With Moderate to Severe Atopic Dermatitis","A Multicenter, Randomized, Double-blind, Parallel, and Positive-controlled Phase III Clinical Study to Evaluate the Equivalence of IBI3027 and Dupilumab Injection in Participants With Moderate to Severe Atopic Dermatitis","Key inclusion criteria:\n\n1. Understand the requirements and process, voluntarily participate in clinical trials and sign consent, willing and able to comply with the requirements of protocol;\n2. Male or female participants aged 18 to 75;\n3. AD diagnosis at screening meeting the Hanifin-Rajka criteria, and the course of AD ≥ 1 year before screening as judged by the investigator;\n4. Moderate to severe AD at screening and baseline, meeting all the following criteria: a. IGA score ≥ 3; b. EASI score ≥ 16; c. BSA≥10%;\n5. Average daily PP-NRS score within 7 days prior to randomization ≥ 4 points;\n6. As assessed by investigator, records indicating poor treatment response with topical local medications, or not suitable for topical treatment due to other medical reasons (such as severe adverse reactions or safety risks, etc.), within 6 months prior to the screening\n\nKey exclusion criteria：\n\n1. Have active skin diseases that may affect the assessment of AD (such as psoriasis or lupus erythematosus), or other skin complications caused by other diseases. Those who are in an acute exacerbation state of AD at the time of randomization (such as participants having rapidly progressing erythroderma or a tendency towards erythroderma, as assessed by the investigators);\n2. Have history of active spring keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC) within 6 months prior to screen;\n3. Suspected immunosuppressive disease within 6 months prior to screen;\n4. Within 2 weeks prior to screen, systemic use of antimicrobial treatment (for viral, bacterial, fungal, or parasitic infections) or having superficial skin infections (such as impetigo);\n5. Participants at high risk of infection;\n6. Within 1 year prior to screen, recurrent herpes zoster or Kaposi's varicelliform eruption (≥ 2 times), disseminated herpes zoster or disseminated herpes simplex;\n7. Positive for human immunodeficiency virus (HIV) antibody;\n8. Participants with syphilis infection;\n9. Positive for the hepatitis C virus (HCV) antibody and HCV RNA (if HCV antibody positive);\n10. Positive for hepatitis B surface antigen (HBsAg) and HBV-DNA (if HBsAg positive);\n11. Previous use IL-4 and\u002For IL-13 targeting drugs (such as dupilumab, etc.) for the treatment of AD with no response or poor efficacy;\n12. Systemic use of IL-4Rα or IL-13 antibody treatment ≤ 3 months or 5 half-lives (if the half-life is known) prior to randomization;\n13. ≥ 2 bleach baths ≤ 2 weeks prior to randomization;\n14. Use of drugs containing main active ingredients such as compound glycyrrhizin or total polysaccharides of peony ≤ 2 weeks prior to randomization;\n15. Following treatments ≤4 weeks prior to randomization: a. systemic use of glucocorticoids or immunosuppressants; b. systemic use of traditional Chinese medicine; c. calcium channel-based anti-epileptic drugs, anti-serotonin agents, and opioid receptor antagonists, with antipruritic effects; d. ultraviolet therapy.\n16. Treatment of allergen-specific immunotherapy ≤ 6 months prior to randomization;\n17. Use of any cell depletion agents including but not limited to rituximab ≤12 months prior to randomization.","75 Years",{"count":119,"type":23},520,[98],"This study is expected to include approximately 520 patients with moderate to severe AD, and they will be randomly assigned to the treatment group (IBI3027) and the control group (Dupilumab Injection ) in a 1:1 ratio.\n\nStudy period: It includes a screening period (4 weeks), a treatment period (44 weeks), and a follow-up period (8 weeks).\n\nAfter screening is completed, participants will be randomly grouped in a 1:1 ratio. On Day 1 (D1), they will receive a loading dose of either IBI3027 or Dupilumab Injection 600 mg by subcutaneous injection (SC), followed by 300 mg each time, SC administration, once every 2 weeks (Q2W), until the last administration on W44. After the treatment is completed, a 8-week safety follow-up will be conducted.",[123],"Atopic Dermatitis","2026-08-05",{"date":81,"type":35},{"date":127,"type":23},"2026-10-20",{"date":129,"type":23},"2028-08-26",{"name":41,"class":42},{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":24,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},"100522384","phase-2-a-study-of-ibi363-in-subjects-with-advanced-melanoma-100522384","NCT06081920","A Study of IBI363 in Subjects With Advanced Melanoma","A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of IBI363 in Subjects With Advanced Melanoma","Inclusion Criteria:\n\n1. Histologically and\u002For cytologically confirmed, unresectable, locally advanced or metastatic melanoma (according to the American Joint Committee on Cancer (AJCC) 8th edition staging III-IV). Progression or recurrence after at least first-line systemic standard treatment.\n2. At least one measurable lesion (target lesion) per RECIST v1.1.\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n4. Life expectancy of 3 months or more.\n5. Female subjects of childbearing age or male subjects whose partners are female subjects of childbearing age agree to strictly adopt effective contraceptive measures throughout the entire treatment period and 6 months after the treatment period.\n\nExclusion Criteria:\n\n1. Pregnant or lactating subjects, or subjects who plan to conceive before, during, or within 6 months after the last dose of the study drug.\n2. Active or symptomatic central nervous system metastasis.\n3. At baseline (within 7 days before the first administration of the study drug), there were any hematological abnormalities as follows: hemoglobin\\\u003C90 g\u002FL; Absolute neutrophil count (ANC)\\\u003C1.5 × 109\u002FL; Platelet count\\\u003C100 × 109\u002FL.\n4. At baseline (within 7 days prior to first administration), there were any serum biochemical abnormalities as follows: Total bilirubin\\>1.5 × ULN; AST or ALT\\>3 × ULN; If it is tumor liver metastasis, AST or ALT\\>5.0 × ULN; Serum creatinine\\>1.5 × ULN or CCr\\\u003C45 mL\u002Fmin, using the Cockcroft Fault formula to calculate CCr (using actual body weight); Albumin\\\u003C30 g\u002FL.\n5. At baseline (within 7 days before first administration), there were any coagulation parameter abnormalities as follows: INR\\>1.5 × ULN (\\>3 if receiving anticoagulant therapy with stabilizer dosage) × ULN); PTT (or activated partial thromboplastin time (aPTT))\\>1.5 × ULN (\\>3 if receiving anticoagulant therapy with stabilizer dosage) × ULN).\n6. History of active thrombosis, deep vein thrombosis, or pulmonary embolism within 4 weeks prior to the first administration of the investigational drug, unless sufficient treatment has been given and the investigator believes that the condition is stable.\n7. Uncontrolled bleeding or known tendency to bleed.",{"count":139,"type":23},180,[77],"This is an open-lable, multicenter Phase II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patients",[143],"Melanoma","2026-07-28",{"date":146,"type":35},"2026-07-29",{"date":148,"type":35},"2023-10-19",{"date":150,"type":23},"2028-10-19",{"name":41,"class":42},12,{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":117,"enrollmentInfo":160,"targetDuration":4,"studyType":24,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":43},"100602375","phase-2-ibi363-combined-with-chemotherapy-or-pembrolizumab-combined-with-chemotherapy-as-neoadjuvant-therapy-in-resectable-stage-ib-iii-non-squamous-non-small-cell-lung-cancer-100602375","NCT07122687","IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer","A Phase II Study Evaluating the Efficacy and Safety of IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Males and Females, age ≥18 years and ≤75 years;\n2. Histologically or cytologically confirmed primary non-squamous NSCLC:\n\n   * Stage IB, II, IIIA or IIIB (N2) NSCLC (per AJCC8);\n   * No administration of any anti-NSCLC therapy in the pre-operative period;\n   * Be able to undergo the radical resection; Pulmonary function capacity capable of tolerating the proposed lung resection according to the surgeon.\n3. Participants without EGFR mutations or ALK translocation;\n4. At least 1 measurable lesion per RECIST v1.1;\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;\n6. Adequate organ function confirmed at screening period.\n\nExclusion Criteria:\n\n1. Histologically confirmed the presence of small cell lung cancer, neuroendocrine carcinoma, sarcoma, salivary gland tumor, and mesenchymal tumor components, or mixed NSCLC with predominant squamous cell carcinoma features;\n2. Tumor invasion of surrounding important structures, which is symptomatic or medical intervention indicated;\n3. Pancoast tumor;\n4. Malignant tumor nodule in the contralateral lung lobe;\n5. Participants with known or suspected brain metastases or other distant metastases;\n6. Participants who received Chinese herbal medicines, proprietary Chinese medicines with anti-tumor indications, or immunomodulatory drugs within 2 weeks prior to the first dose of the study drug;\n7. Participants with a condition requiring systemic treatment with corticosteroids or is receiving any other form of immunosuppressive therapy within 7 days prior the first dose of the study drug;\n8. History of any arterial thromboembolic event within 6 months prior to the first dose of the study drug;\n9. History of deep vein thrombosis, pulmonary embolism, or any other serious venous thromboembolism within 3 months prior to the first dose of study drug;\n10. History of pneumonitis requiring corticosteroid therapy, or history of clinically significant lung diseases or who are suspected to have these diseases by imaging during the screening period;\n11. Active or uncontrolled diseases or conditions;\n12. History of immunodeficiency disease;\n13. Participants with active autoimmune disease requiring systemic treatment within 2 years prior to the first dose of the study drug.",{"count":161,"type":23},170,[77],"This study is a randomized, open-label Phase 2 study to compare the efficacy and safety of IBI363 Combined with Chemotherapy or Pembrolizumab Combined with Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer.",[165],"Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer","2026-07-24",{"date":168,"type":35},"2026-07-27",{"date":170,"type":35},"2025-08-26",{"date":172,"type":23},"2030-04-30",{"name":41,"class":42},{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":17,"sex":181,"minAge":19,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":24,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":43},"100637788","phase-1-clinical-trials-of-ibi3035-in-healthy-subjects-100637788","NCT07591519","Clinical Trials of IBI3035 in Healthy Subjects","Evaluation of the Pharmacokinetics and Pharmacodynamics of IBI3035 and Awiqli? (Ecoporin Insulin Injection) in a Randomized, Open-label, Single-dose, Two-formulation, Crossover Design in Healthy Male Subjects in China: A Phase I Clinical Trial.","Inclusion Criteria\n\nThe following inclusion criteria must be met:\n\n1. Healthy male adult subjects aged 18 to 45 years (including 18 and 45 years, based on the date of signing the informed consent form) of Chinese nationality;\n2. Body Mass Index (BMI) between 19.0 and 24.0 kg\u002Fm2 (including both values) at screening, and weight ≥ 50 kg;\n3. Normal glucose tolerance at screening \\[3.9 mmol\u002FL \\\u003C fasting blood glucose \\\u003C 6.1 mmol\u002FL, and 2-hour post-glucose load blood glucose \\\u003C 7.8 mmol\u002FL in the oral glucose tolerance test (OGTT)\\]; normal insulin secretion function or abnormality without clinical significance as determined by the investigator \\[confirmed by the insulin release test (IRT)\\];\n4. Glycated hemoglobin ≤ 6.0% at screening;\n5. Agree to take effective contraceptive measures during the study period and within 6 months after the last dose and have no plan to donate sperm;\n6. Able to understand the procedures and methods of this study, willing to strictly follow the clinical trial protocol to complete the trial, and voluntarily sign the informed consent form.\n\nExclusion Criteria\n\nSubjects who meet any of the following exclusion criteria cannot be included in this study:\n\n1. Known or suspected to be allergic to the investigational drug in this study;\n2. Have taken any drugs that affect insulin hypoglycemic effects within 28 days before screening (such as corticosteroids, diuretics, epinephrine, salbutamol, glucagon, thyroid hormones, etc.);\n3. Have a history of clinical significance as determined by the investigator at screening or before randomization, including diseases of the endocrine system, blood system, cardiovascular system, respiratory system, digestive system, urinary system, immune system, nervous system, or any other disease that can significantly alter the absorption, metabolism, or elimination of drugs;\n4. Have a clear diagnosis of hyperglycemia or hypoglycemia within 3 months before screening;\n5. Have an increased risk of thrombosis at screening, including personal or family history of deep vein thrombosis;\n6. Have abnormal indicators with clinical significance at screening or before randomization: vital signs, physical examination, laboratory tests, chest X-ray, and 12-lead ECG as determined by the investigator;\n7. Have had a severe infection, trauma, or surgery within 4 weeks before screening;\n8. Have smoked more than 5 cigarettes per day within 3 months before screening, or have smoked within 48 hours before using the investigational drug or cannot stop using any tobacco products during the trial;\n9. Have used any prescription drugs, Chinese herbal medicines, over-the-counter drugs, or health supplements (except for regular vitamin supplements) within 2 weeks before screening;\n10. Have donated blood ≥ 400 ml or had any component blood donation within 3 months before screening, or have lost a total of ≥ 400 ml of blood for any reason, or have a history of blood transfusion or use of blood products;\n11. Have consumed more than 14 units of alcohol per week within 3 months before screening: 1 unit ≈ 360 ml of beer, or 45 ml of spirits, or 150 ml of wine, and cannot abstain from alcohol within 48 hours before using the investigational drug;\n12. Have consumed excessive amounts of tea, coffee, and\u002For caffeine-rich beverages (more than 8 cups, 1 cup ≈ 250 ml) daily within 3 months before screening;\n13. Have positive results for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or Treponema pallidum antibodies;\n14. Have a history of drug abuse or drug use within 3 months before screening, or have positive results for alcohol tests or urine drug screening at screening. 15. Participants who have participated in other clinical trials and used investigational drugs or medical devices within the 3 months prior to screening;\n\n16\\. Participants with a weight change greater than 5% within the 3 months prior to screening \\[(maximum weight within the 3 months prior to screening - minimum weight within the 3 months prior to screening) \u002F minimum weight within the 3 months prior to screening × 100%, as self-reported by the participant\\]; 17. Participants with any food allergies or special dietary requirements that prevent them from adhering to a uniform diet (such as intolerance to standard meal foods, lactose intolerance, etc.); 18. Participants who have experienced acute diseases during the screening period; 19. Participants with a history of fainting at the sight of needles or blood, who cannot tolerate venipuncture blood collection, or who have difficulty with blood collection; 20. Participants for whom the investigator deems there to be any circumstances that make them unsuitable for participation in the trial.","MALE","45 Years",{"count":184,"type":23},144,[26],"This study is a Phase I clinical trial that uses positive glucose clamping technology to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence of IBI3035 with insulin injection (Awiqli?) after a single administration in healthy male subjects",[188],"Healthy Person","2026-07-14",{"date":191,"type":35},"2026-07-16",{"date":193,"type":35},"2026-05-08",{"date":195,"type":23},"2027-08-31",{"name":41,"class":42},{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":117,"enrollmentInfo":204,"targetDuration":4,"studyType":24,"phases":206,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":43},"100640760","phase-1-a-study-of-ibi3031-in-participants-with-thyroid-eye-disease-100640760","NCT07622368","A Study of IBI3031 in Participants With Thyroid Eye Disease","A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of IBI3031 in Participants With Thyroid Eye Disease","Key Inclusion Criteria:\n\n1. Written informed consent.\n2. Aged between 18 and 75 years at screening.\n3. Weight between 45 kg and 100 kg.\n4. Moderate-to-severe active TED:\n\n   * CAS ≥ 3 in the study eye at screening and baseline;\n   * Usually associated with at least two of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal, and\u002For inconstant or constant diplopia;\n   * ≤ 12 months since the onset of active TED symptoms according to subjects' chief complaint or medical record at screening;\n5. Exophthalmos ≥ 18 mm in the study eye at baseline. (Only applicable to Stage 2)\n6. Participants must be clinically and biochemically euthyroid, or have mild hypothyroidism or mild-to-moderate hyperthyroidism at screening.\n7. Positive for Thyrotrophin Receptor Antibody (TRAb) at screening.\n8. No prior treatment with antithyroid medications and\u002For thyroid hormone replacement therapy, or having taken antithyroid medications and\u002For thyroid hormone replacement therapy on a stable dose for at least 6 weeks prior to the first dose, or having not been treated with antithyroid medications and\u002For thyroid hormone replacement therapy due to intolerable side effects for at least 6 weeks prior to the first dose.\n9. Infertile female participants or fertile female participants with negative blood pregnancy test results during the screening period and agree to take contraceptive measures from screening to 120 days after the last dose; male participants should agree to use contraceptive measures from screening to 120 days after the last dose.\n\nKey Exclusion Criteria:\n\nParticipants to be excluded (Participants meeting any of the following criteria will be regarded as ineligible):\n\n1. The CAS of the study eye at baseline is reduced by ≥ 2 points compared with that at screening, or the proptosis of the study eye at baseline is reduced by ≥ 2 mm compared with that at screening;\n2. Participants previously diagnosed with dysthyroid optic neuropathy (DON), or with DON as determined by the investigator at screening;\n3. Patients with corneal ulcers that are not relieved after treatment at the investigator's discretion;\n4. Presence of other non-TED ophthalmic diseases that may affect the interpretation of study results or the safety of participants as determined by the investigator (e.g., proptosis not primarily caused by TED);\n5. At screening, clinical or laboratory evidence of significant hypothyroidism (presence of clinical symptoms of hypothyroidism, or FT3 or FT4 (Free Thyroxine)\\\u003C0.5×lower limit of normal \\[LLN\\], or TSH\\>1.5×upper limit of normal \\[ULN\\]); or severe hyperthyroidism during the screening period (FT3 and FT4(Free Thyroxine)\\>2×ULN, or presence of thyroid storm).\n6. Other medical history and abnormal test results during the screening period that are judged by the investigator to be clinically significant, may cause the participant to fail to comply with the study protocol or complete the trial, or endanger safety, including but not limited to:\n\n   * History of hepatic insufficiency (Child-Pugh Class B or C) or liver cirrhosis; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2 × ULN at screening;\n   * Glomerular filtration rate (GFR) \\\u003C 60 ml\u002Fmin\u002F1.73 m2;\n   * Poorly controlled diabetes mellitus or hypertension;\n   * Confirmed or clinically suspected inflammatory bowel disease, gastrointestinal bleeding, or peptic ulcer disease.\n   * History of of chronic or recurrent infections; opportunistic infection within 180 days prior to screening;\n   * Positive for human immunodeficiency virus antibody (HIV Ab), hepatitis C virus antibody (HCV Ab), non-specific syphilis antibody (e.g., RPR(Rapid Plasma Reagin), TRUST), hepatitis B virus surface antigen (HBsAg) or e-antigen (HBeAg), or interferon-gamma release assay (IGRA).\n   * History of tinnitus or other hearing impairment in either ear during the screening period; or abnormal pure tone audiometry results (defined as an average bone conduction hearing threshold of ≥ 25 dB(decibe) at 0.5, 1, 2, and 4 kHz(kilohertz), or a bone conduction hearing threshold of ≥ 40 dB at any frequency);\n7. Scheduled radioactive iodine therapy or thyroidectomy at any time before screening or during the study;\n8. Scheduled orbital radiotherapy at any time before screening or during the study, or surgical treatment for TED, including orbital decompression, strabismus surgery, and eyelid surgery;\n9. Cumulative dose of glucocorticoids used to treat TED ≥ 1 g of methylprednisolone equivalents within 90 days prior to screening;\n10. Oral or intravenous glucocorticoids within 30 days prior to screening;\n11. Peribulbar\u002Fperiorbital injection of glucocorticoids within 90 days prior to screening;\n12. Oral or intravenous administration of any other non-steroidal immunosuppressants within 90 days prior to screening;\n13. Use of glucocorticoid eye drops\u002Fointments or use of non-steroidal immunosuppressant eye drops within 14 days prior to screening;\n14. Received antibody therapy targeting IGF-1R, TSHR, CD20(cluster of differentiation antigen 20), IL-6, or IL-6 receptor (IL-6R) at any time before screening;\n15. Received any other TED therapeutic drugs under development (including but not limited to biologics targeting IGF-1R, FcRn(neonatal Fc recepto), IL-6, or IL-6R) at any time before screening;\n16. Use of any other monoclonal antibody within 90 days prior to screening;\n17. Have received live vaccines within 180 days prior to screening, or plan to receive live vaccines during the study;\n18. Female participants in pregnancy or lactation.",{"count":205,"type":23},66,[26],"This is a multicenter, randomized, double-masked, placebo-controlled, single\u002Fmultiple-dose-escalation trial conducted in Chinese participants with Thyroid Eye Disease (TED), aiming to evaluate the safety and tolerability of IBI3031 administered via subcutaneous or intravenous injection.",[58],"2026-07-13",{"date":189,"type":35},{"date":212,"type":35},"2026-06-30",{"date":214,"type":23},"2027-12-28",{"name":41,"class":42},{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":117,"enrollmentInfo":223,"targetDuration":4,"studyType":24,"phases":225,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":43},"100635925","phase-1-safety-and-preliminary-activity-of-bi115-in-advanced-sclc-100635925","NCT07559019","Safety and Preliminary Activity of BI115 in Advanced SCLC","Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of IBI115 as Monotherapy and in Combination Therapy in Participants With Advanced Small Cell Lung Cancer","Inclusion Criteria：\n\n1. Participants must be able to understand and sign the written informed consent form for participation in this trial, including all evaluations and procedures specified in this protocol.\n2. Male or female participants aged ≥18 years and ≤75 years.\n3. Participants with histologically or cytologically confirmed advanced small cell lung cancer.\n4. At least one measurable lesion according to RECIST V1.1 within 28 days prior to the first dose of IBI115.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n6. Expected survival period ≥12 weeks.\n7. Adequate bone marrow and organ function confirmed during the screening period.\n\nExclusion Criteria：\n\n1. Concurrent participation in another interventional clinical study, except for observational non-interventional studies or being in the survival follow-up phase of an interventional study.\n2. Administration of a live vaccine within 4 weeks prior to the first dose of the study drug or a cancer vaccine within 3 months prior, or planning to receive any live vaccine during the study period.\n3. Adverse reactions from prior anti-tumor therapy that have not resolved to CTCAE v6.0 Grade 0, Grade 1, or baseline levels by the time of the first dose of the study drug.\n4. Known hypersensitivity or intolerance to IBI115, sintilimab, or any of their excipients.",{"count":224,"type":23},150,[26],"This study is a multi-regional, open-label phase I study to evaluate the Safety, Tolerability, and Efficacy of IBI115 as Monotherapy and in Combination Therapy in Participants with Advanced Small Cell Lung Cancer",[228],"Small Cell Lung Cancer (SCLC)","2026-06-02",{"date":231,"type":35},"2026-06-04",{"date":233,"type":35},"2026-05-21",{"date":235,"type":23},"2030-03-30",{"name":41,"class":42},{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":24,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":43},"100630121","phase-2-ibi343-in-combination-therapy-for-advanced-malignant-solid-tumors-100630121","NCT07483554","IBI343 in Combination Therapy for Advanced Malignant Solid Tumors","A Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of IBI343 in Combination Therapy for Patients With Advanced Malignant Solid Tumors.","Inclusion criteria:\n\n1. Signed written informed consent, willing and able to comply with the protocol-specified visits and related procedures.\n2. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n3. Age ≥ 18 years, no gender restrictions.\n4. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n5. Expected survival ≥ 12 weeks.\n6. Adequate bone marrow and organ function.\n7. Female subjects of childbearing potential or male subjects whose partners are of childbearing potential must use effective contraception throughout the treatment period and for 6 months after the end of treatment.\n8. Confirmed CLDN18.2 positive by central laboratory pathological tissue testing.\n\nExclusion criteria:\n\n1. Currently participating in another interventional clinical study, except for observational (non-interventional) clinical studies or those in the survival follow-up phase of an interventional study.\n2. Received treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of the investigational drug.\n3. Received the last anti-tumor treatment within 4 weeks or 5 half-lives of the anti-tumor therapy (whichever is shorter) before the first dose of the investigational drug.\n4. Received therapeutic or palliative radiotherapy within 2 weeks prior to the first dose of the investigational drug.\n5. Underwent biliary stent placement within 7 days prior to the first dose of the investigational drug.\n6. Planning to receive other anti-tumor treatments during the period of treatment with the investigational drug.\n7. Received any live vaccine within 4 weeks prior to the first dose of the investigational drug or planning to receive any live vaccine during the study.\n8. Underwent major surgery within 4 weeks prior to the first dose of the investigational drug, or has unhealed wounds, ulcers, or fractures; or plans to undergo major surgery during the study.\n9. Has not recovered from toxicity caused by previous treatment to grade 0 or 1 according to NCI CTCAE v5.0 prior to the first dose of the investigational drug.\n10. History of gastrointestinal perforation and\u002For fistula within 6 months prior to the first dose of the investigational drug that was not cured by surgical treatment.\n11. Presence of pyloric obstruction and\u002For persistent recurrent vomiting.\n12. Post-procedure of stent implantation in the digestive tract or trachea.\n13. Symptomatic central nervous system metastasis.\n14. Bone metastasis with risk of paraplegia.\n15. Interstitial lung disease requiring steroid treatment, or history of interstitial lung disease, non-infectious pneumonia, severe impairment of pulmonary function, or uncontrolled pulmonary disease such as pulmonary fibrosis, severe radiation pneumonitis, acute lung injury, etc., or suspected of having these diseases during the screening period.\n16. Presence of uncontrolled disease.\n17. History of other primary malignant tumors.\n18. Known history of immunodeficiency.\n19. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n20. Previous treatment with topoisomerase inhibitor-based antibody-drug conjugates.\n21. For subjects receiving drug treatment, a history of allergy to the corresponding drug or formulation.\n22. For subjects receiving drug treatment, contraindications for the corresponding drug.\n23. For subjects receiving drug treatment, a history of permanent discontinuation of the corresponding drug due to related adverse reactions.\n24. Pregnant or lactating female subjects.\n25. Other conditions deemed unsuitable for participation in this study by the investigator.",{"count":245,"type":23},389,[77],"A Phase II study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of IBI343 in combination therapy for patients with advanced malignant solid tumors.To evaluate the efficacy and safety of IBI343 in combination therapy for patients with advanced malignant solid tumors.Enrollment of subjects with advanced gastric\u002Fgastroesophageal junction adenocarcinoma positive for CLDN18.2, and subjects with pancreatic ductal adenocarcinoma positive for CLDN18.2.",[249,250,251],"CLDN18.2 Positive","Gastric\u002FGastroesophageal Junction Adenocarcinoma","Pancreatic Ductal Adenocarcinoma",{"date":253,"type":35},"2026-06-03",{"date":255,"type":35},"2026-04-20",{"date":257,"type":23},"2028-03-31",{"name":41,"class":42},{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":117,"enrollmentInfo":266,"targetDuration":4,"studyType":24,"phases":268,"briefSummary":269,"conditions":270,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":278,"locationsCount":43},"100630122","phase-2-ibi343-in-combination-with-sintilimab-and-sox-regimen-for-perioperative-treatment-of-resectable-locally-advanced-gastric-or-gastroesophageal-junction-adenocarcinoma-100630122","NCT07483567","IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","A Randomized, Open-label, Multicenter Phase II Clinical Study to Explore the Perioperative Treatment of Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma With IBI343 in Combination With Sintilimab and SOX Regimen.","Inclusion criteria\n\n1. Signed written informed consent and able to comply with the visit and related procedures as specified in the protocol.\n2. Male or female, 18 years ≤ age ≤ 75 years;\n3. ECOG score 0-1;\n4. Histologically confirmed, previously untreated patients with gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction; only Siewert II\u002FIII type participants are allowed for gastroesophageal junction cancer;\n5. Clinical staging based on enhanced CT\u002FMRI examination, clinical stage T3\\~4a with positive lymph nodes, and no distant metastasis;\n6. The research center and surgeon can perform radical D2 lymph node dissection surgery, R0 resection;\n7. Physical condition and organ function allow for major abdominal surgery;\n8. Confirmed CLDN18.2 expression by central laboratory pathological tissue testing.\n9. Adequate organ and bone marrow function.\n10. Echocardiography confirms left ventricular ejection fraction (LVEF) ≥ 50%;\n11. Female participants must agree not to breastfeed from screening through the entire treatment period and up to 6 months after the last dose.\n12. Female participants of childbearing potential or male participants whose partners are of childbearing potential must use effective contraception from screening through the entire treatment period and up to 9 months after the last dose.\n\nExclusion criteria\n\n1. HER2 positive.\n2. Currently participating in another interventional clinical study, except for those in the follow-up phase of an interventional study.\n3. Previous use of traditional Chinese medicine, Chinese patent medicines, or immunomodulators must be ≥2 weeks before starting the study medication.\n4. Received treatment with a strong CYP3A4 inhibitor within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of the study drug.\n5. Received any live vaccine within 4 weeks prior to the first dose of the study drug or plans to receive any during the study period.\n6. Underwent major surgery (craniotomy, thoracotomy, laparotomy, laparoscopic resection of significant tissues or organs, or other as defined by the investigator, excluding needle biopsies) within 4 weeks prior to the first dose of the study drug, or has unhealed wounds, ulcers, or fractures.\n7. Patients who received steroids (\\>10 mg\u002Fday prednisone equivalent) or other immunosuppressive drugs within 14 days before enrollment. However, patients are allowed to enroll if they use topical or inhaled steroids, or adrenal replacement therapy with ≤10 mg\u002Fday prednisone equivalent, without active autoimmune disease.\n8. History of interstitial lung disease, non-infectious pneumonia, severely impaired pulmonary function, or uncontrolled pulmonary disease such as pulmonary fibrosis, severe radiation pneumonitis, acute lung injury, etc., or suspected of having such conditions during the screening period.\n9. Presence of uncontrolled diseases, such as:\n\n   • Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg).\n10. Any arterial thromboembolic event within 6 months prior to the first dose of the study drug, including myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, etc.\n11. History of deep vein thrombosis (patients stable on anticoagulation for at least 2 weeks can be enrolled), pulmonary embolism, or any other serious venous thromboembolic event within 3 months prior to the first dose of the study drug (implantable venous port or catheter-related thrombosis, or superficial venous thrombosis, are not considered \"serious\" venous thromboembolic events).\n12. Any life-threatening bleeding event or Grade 3 or 4 gastrointestinal\u002Fvariceal bleeding event requiring transfusion, endoscopic, or surgical intervention within 3 months prior to the first dose of the study drug.\n13. Hepatic encephalopathy, hepatorenal syndrome, Child-Pugh B or more severe liver cirrhosis.\n14. Complete or partial intestinal obstruction present during the screening period or history of complete or partial intestinal obstruction within 3 months prior to the first dose of the study drug, or risk of bowel perforation (including but not limited to acute diverticulitis, history of intra-abdominal abscess) or history of inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.\n15. Other acute or chronic diseases or laboratory abnormalities that may result in: increased risk related to participation in the study or administration of the study drug, interference with the interpretation of study results, and participants deemed ineligible for the study by the investigator.\n16. Uncontrolled metabolic disorders or other non-malignant organ or systemic diseases or secondary reactions to cancer (such as leukemoid reaction, etc.), which may lead to higher medical risks and\u002For uncertainty in survival evaluation.\n17. Neurological, psychiatric, or social conditions that: affect compliance with study requirements, significantly increase the risk of adverse events, or impair the ability of the participant to provide written informed consent.\n18. History of other primary malignant tumors.\n19. Known history of immunodeficiency.\n20. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n21. History of allergic reactions to the drugs used in this study.\n22. Other conditions deemed unsuitable for participation in this study by the investigator.",{"count":267,"type":23},90,[77],"This study is a prospective, randomized, open, multicenter phase II clinical trial. It plans to enroll 70 participants with locally advanced gastric and gastroesophageal junction adenocarcinoma (G\u002FGEJ AC) who are assessed as suitable for D2 radical surgery and capable of R0 resection.To evaluate the clinical efficacy and tolerability of IBI343 in combination with sintilimab and SOX regimen for perioperative treatment of resectable, locally advanced gastric or gastroesophageal junction adenocarcinoma.Enroll patients who are CLDN18.2 positive.",[249,271,272],"Primary Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","2026-05-29",{"date":229,"type":35},{"date":276,"type":35},"2026-04-17",{"date":86,"type":23},{"name":41,"class":42},{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":24,"phases":288,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":43},"100641005","phase-3-a-study-in-participants-with-relapsed-or-refractory-multiple-myeloma-for-ibi3003-100641005","NCT07623798","A Study in Participants With Relapsed or Refractory Multiple Myeloma for IBI3003","A Phase 3 Randomized Study Comparing IBI3003 Versus Treatment Per Investigator's Choice in Participants With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria：\n\n1. Age ≥18 years.\n2. Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria.\n3. At least one of the following measurable disease indicators:\n\n   * Serum M-protein ≥ 5 g\u002FL（For IgA and IgD subtypes, it is recommended to use quantitative immunoglobulin measurements instead of M protein）\n   * Urine M-protein ≥200 mg\u002F24h\n   * Serum free light chain (FLC) test: affected FLC level ≥100 mg\u002FL and abnormal serum FLC ratio (\\\u003C0.26 or \\>1.65)\n4. Life expectancy ≥3 months.\n5. Fertile females and sexually active fertile males must agree to use highly effective contraception (failure rate \\\u003C1% per year) during the study and for 90 days after the last dose of the investigational drug. For participants in the clinical trial, contraceptive measures must comply with local regulations regarding the use of contraceptive methods. Females and males must agree not to donate eggs (ova, oocytes) or sperm during the study and for 90 days after the last dose of the investigational drug.\n6. Willing and able to comply with the prohibitions and restrictions specified in this protocol.\n\nExclusion Criteria：\n\n1. Previous treatment with any BCMA-targeted therapy and any GPRC5D-targeted therapy. Patients who have received either BCMA-targeted or GPRC5D-targeted therapy are allowed to participate in the study.\n2. Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.\n3. Spinal cord compression that leads to limited self-care ability occurs within six months prior to informed consent or is expected to occur in the near future.\n4. Have history of primary immunodeficiency.\n5. Have history of organ transplantation.\n6. Have received allogeneic hematopoietic stem cell transplantation within 6 months before the first administration of the study drug, or have received autologous stem cell transplantation within 3 months before the first administration of the study drug.",{"count":287,"type":23},255,[98],"The purpose of this study is to evaluate how well IBI3003 works when compared with the investigator's choice regimen (DPd or PVd)",[291],"Relapsed or Refractory Multiple Myeloma","2026-05-28",{"date":253,"type":35},{"date":295,"type":23},"2026-06-05",{"date":297,"type":23},"2029-12-31",{"name":41,"class":42},{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":24,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":43},"100629065","phase-3-efficacy-and-safety-of-ibi362-in-hypertensive-patients-with-overweightobesity-100629065","NCT07469800","Efficacy and Safety of IBI362 in Hypertensive Patients With Overweight\u002FObesity","A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of IBI362 in Participants With Mild to Moderate Hypertension Complicated by Overweight\u002FObesity Who Have Not Received Antihypertensive Drug Treatment","Inclusion Criteria:\n\n1. Aged ≥ 18 years old at the time of signing the informed consent form.\n2. Confirmed diagnosis of hypertension.\n3. No prior history of antihypertensive medication treatment at screening; or previously received only one type of antihypertensive medication during the same period and has discontinued all antihypertensive medications for at least 2 weeks prior to screening.\n4. Voluntarily sign the informed consent form and be willing to strictly comply with the requirements and restrictions stated in the informed consent form and the protocol throughout the study, including but not limited to: maintaining a stable diet and exercise routine, receiving the study drug injections as scheduled, and keeping a study diary.\n\nExclusion Criteria:\n\n1. The investigator suspects that the participant may be allergic to the components of the study drug or drugs of the same class.\n2. History of orthostatic hypotension, or blood pressure measured at screening meeting the criteria for orthostatic hypotension.\n3. History or diagnostic evidence of secondary hypertension other than obstructive sleep apnea, including but not limited to: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), aortic stenosis, primary aldosteronism, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.\n4. Concurrent use of beta-blockers within 1 month prior to screening.\n5. Self-reported body weight change \\> 5 kg within 3 months.\n6. History of acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, percutaneous coronary intervention (excluding diagnostic angiography), large artery aneurysm or dissecting aneurysm, transient ischemic attack (TIA), cerebrovascular accident, severe arrhythmia (e.g., ventricular fibrillation, ventricular flutter, atrial fibrillation, atrial flutter, second-degree or higher atrioventricular block, sick sinus syndrome, etc.) within 6 months; or history of decompensated heart failure or heart failure of New York Heart Association (NYHA) Class III or IV; or history of severe diseases such as epilepsy or syncope, which the investigator deems unsuitable for trial participation.\n7. Confirmed diagnosis of diabetes mellitus, or laboratory tests showing glycated hemoglobin (HbA1c) ≥ 6.5%, fasting blood glucose ≥ 7 mmol\u002FL and\u002For random blood glucose ≥ 11.1 mmol\u002FL.\n8. History of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, acute cholangitis, or symptomatic\u002Ftreated gallbladder disease (except for participants who have undergone cholecystectomy and are judged eligible by the investigator); or serum amylase or lipase \\> 2.0 × Upper Limit of Normal (ULN); or fasting serum triglycerides ≥ 5.64 mmol\u002FL (500 mg\u002Fdl).\n9. Chronic gastrointestinal diseases or systemic diseases that may affect gastrointestinal motility at screening, or use of drugs that may alter gastrointestinal motility, appetite or absorption within 3 months prior to screening.\n10. History or relevant family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type 2A or 2B.",{"count":307,"type":23},336,[98],"A multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of IBI362 in participants with mild to moderate hypertension complicated by overweight\u002Fobesity who have not received antihypertensive drug treatment",[311,312,313],"Overweight","Obesity","Hypertensive","2026-05-24",{"date":316,"type":35},"2026-05-27",{"date":318,"type":35},"2026-04-23",{"date":320,"type":23},"2027-04-15",{"name":41,"class":42},{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":24,"phases":331,"briefSummary":332,"conditions":333,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":335,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":43},"100638513","phase-1-study-of-ibi3005-combination-therapy-in-participants-with-unresectable-locally-advanced-or-metastatic-solid-tumors-100638513","NCT07612137","Study of IBI3005 Combination Therapy in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors","A Phase Ib\u002FII Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IBI3005 Combination Therapy in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Has signed a written informed consent form (ICF) and is able to comply with the scheduled study visits and related procedures.\n2. Age ≥ 18 years, irrespective of gender.\n3. Confirmed diagnosis of locally advanced unresectable or metastatic solid tumor.\n4. Expected survival ≥ 12 weeks.\n5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.\n6. Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days prior to the first study drug administration.\n7. Adequate bone marrow and organ function.\n\nAdditional Inclusion Criteria for Cohort 1:\n\n1. Histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC.\n2. Tumor harboring EGFR-sensitive mutations (Ex19del or L858R, with or without other EGFR mutations) confirmed via histology or cytology specimens.\n3. In the safety run-in phase, NSCLC participants who have received prior standard therapy.\n4. In the cohort expansion phase, participants without driver gene mutations who have not received prior systemic anti-tumor therapy for unresectable locally advanced or metastatic disease.\n\nAdditional Inclusion Criteria for Cohort 2:\n\n1. Histologically or cytologically confirmed unresectable locally advanced or metastatic non-squamous NSCLC.\n2. In the safety run-in phase, participants should have received prior standard therapy.\n\n   In the cohort expansion phase:\n3. Cohort 2A: NSCLC participants without driver gene mutations (including at least EGFR, ALK, and ROS1, with written documentation) who have not received prior systemic anti-tumor therapy for unresectable locally advanced or metastatic disease. Participants who received neoadjuvant\u002Fadjuvant therapy are eligible if disease recurrence or progression occurred \\>6 months after the last neoadjuvant\u002Fadjuvant therapy.\n4. Cohort 2B: NSCLC participants with tumor harboring EGFR-sensitive mutations (Ex19del or L858R, with or without other EGFR mutations) confirmed via histology or cytology specimens, who have experienced disease progression after prior EGFR-TKI therapy.\n\nAdditional Inclusion Criteria for Cohort 3\n\n1. Histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC.\n2. Tumor harboring EGFR-sensitive mutations (Ex19del or L858R, with or without other EGFR mutations) confirmed via histology or cytology specimens.\n3. In the safety run-in phase, participants should have experienced disease progression after prior EGFR-TKI therapy.\n4. In the cohort expansion phase, NSCLC participants who have not received prior systemic anti-tumor therapy for unresectable locally advanced or metastatic disease. Participants who received neoadjuvant\u002Fadjuvant therapy are eligible if disease recurrence or progression occurred \\>6 months after the last neoadjuvant\u002Fadjuvant therapy.\n\nExclusion Criteria:\n\n1. Participation in any other interventional clinical study, except for observational (non-interventional) studies or the follow-up period after the end of study treatment in an interventional study.\n2. Prior treatment with antibody-drug conjugate (ADC) drugs bearing a camptothecin or its derivative (topoisomerase I inhibitor) small-molecule payload.\n3. Prior to the first dose of study drug: a) Within 4 weeks: Received intravenous chemotherapy, macromolecular targeted therapy, antibody-drug conjugates, immunotherapy, endocrine therapy, cell therapy, intraperitoneal perfusion chemotherapy, tumor embolization, or interventional chemotherapy. b) Within 2 weeks or 5 half-lives (whichever is shorter): Received oral chemotherapy, small-molecule targeted therapy, or traditional Chinese herbal medicines indicated for anti-tumor treatment. c) Within 4 weeks: Received radical radiotherapy; within 2 weeks: Received palliative radiotherapy. d) Within 2 weeks or 5 half-lives (whichever is shorter): Received strong inhibitors or strong inducers of cytochrome P450 3A4 (CYP3A4). e) Within 4 weeks: Underwent major surgery (craniotomy, thoracotomy, laparotomy, or other surgeries deemed \"\"major\"\" by the investigator, excluding puncture biopsy), or has severe unhealed wounds, trauma, or ulcers; within 2 weeks: Underwent laparoscopic exploratory surgery. f) Within 4 weeks: Received live vaccine (mRNA and non-replicating adenovirus vaccines are not considered live vaccines).\n4. Presence of adverse events from prior anti-tumor therapy that have not resolved to Grade 0 or 1 per NCI-CTCAE v5.0 \\[excluding Grade 2 alopecia, fatigue, pigmentation, insomnia, peripheral neuropathy, hypomagnesemia, and toxicities stably controlled by medication (e.g., hypothyroidism stably controlled by replacement therapy, hypertension with blood pressure stably controlled below 160\u002F100 mmHg by antihypertensive medication)\\].\n\nAdditional Exclusion Criteria for Cohort 1:\n\n1. History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic therapy.\n2. History of significant toxicity associated with immune checkpoint inhibitor administration that required permanent discontinuation of such therapy.\n\nAdditional Exclusion Criteria for Cohort 2:\n\n1. History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic therapy.\n2. History of significant toxicity associated with immune checkpoint inhibitor administration that required permanent discontinuation of such therapy.\n3. History of hemoptysis within 3 months prior to the first dose (blood volume \\>2.5 mL per cough or cumulative daily hemoptysis \\>10 mL), or current active bleeding.\n\nContinuous use of aspirin (\\>325 mg\u002Fday) or other non-steroidal anti-inflammatory drugs known to inhibit platelet function within 2 weeks prior to the first dose.\"",{"count":330,"type":23},282,[26,77],"To evaluate the safety and tolerability of IBI3005 combination therapy in participants with advanced solid tumors; to evaluate the antitumor activity of IBI3005 combination therapy in participants with advanced solid tumors.",[334],"Solid Tumor",{"date":292,"type":35},{"date":337,"type":23},"2026-06-01",{"date":339,"type":23},"2028-06-30",{"name":41,"class":42},{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":24,"phases":350,"briefSummary":351,"conditions":352,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":362},"100474462","phase-1-a-first-in-human-study-of-ibi343-in-subjects-with-locally-advanced-unresectable-or-metastatic-solid-tumors-100474462","NCT05458219","A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors","A Phase 1a\u002Fb, Multicenter, Open-label, First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors","Inclusion Criteria:\n\nInclusion criteria to be met for both Phase Ia and Phase Ib:\n\n1. Has signed written Informed Consent Form (ICF), willing and able to comply with protocol-specified visits and related procedures.\n2. Phase Ia dose escalation phase, Phase Ia part 3 1L G\u002FGEJ AC and 1L PDAC cohorts Safety Lead-in stage: Has at least 1 evaluable lesion according to RECIST v1.1; Phase Ia dose expansion and dose optimization phase, Phase Ia part 3 1L G\u002FGEJ AC and 1L PDAC cohorts Dose optimization stage, Phase Ib: Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors RECIST v1.1.\n3. Age ≥ 18 years, of either sex.\n4. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n5. Has an expected survival ≥ 12 weeks.\n6. Has adequate bone marrow and organ function. Defined as:\n\n   • Hematology: ANC ≥ 1.5 × 109\u002FL; Platelet count ≥ 100 × 109\u002FL; Hemoglobin ≥ 9.0 g\u002FdL, participants must not have received transfusion of blood products (including red blood cell suspension, apheresis platelets, cryoprecipitate, etc.), erythropoietin (EPO), G-colony stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating factor (GM-CSF) within 7 days prior to blood sample collection;\n   * Hepatic function: TBIL ≤ 1.5 × ULN (TBIL ≤ 3 × ULN is allowed for participants with Gilbert's syndrome); ALT and AST ≤ 2.5 × ULN for participants without liver metastasis and ≤ 5 × ULN for participants with liver metastasis; Albumin ≥ 28 g\u002FL;\n   * Renal function: estimated creatinine clearance ≥ 30mL\u002Fmin (using Appendix 5. Calculation of Estimated Creatinine Clearance and Body Surface ).\n   * Coagulation function: international normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (participants receiving anticoagulant therapy with coagulation function within the above range are allowed).\n7. Female participants of childbearing potential or male participants whose partners are female of childbearing potential are required to use effective contraceptive measures throughout the treatment period and for 6 months after the final treatment period.\n\nInclusion Criteria for Phase Ia Dose Escalation:\n\n1. Participants with histopathologically confirmed unresectable locally advanced or metastatic malignant solid tumors that have failed or were intolerant to standard therapy or for whom no standard therapy is available.\n\nInclusion Criteria for Phase Ia Dose Expansion, Dose Optimization :\n\n1. Participants with histopathologically confirmed unresectable locally advanced or metastatic G\u002FGEJ AC, PDAC, BTC, or other solid tumors who have failed or were intolerant to standard therapy or for which no standard therapy is available.\n2. \\* CLDN18.2-positive confirmed by pathological examination (in dose expansion phase, G\u002FGEJ AC and PDAC preferentially enrolled \\*\\*\\* moderate to high expression of CLDN18. 2; in dose optimization phase , G\u002FGEJ AC preferentially enrolled \\*\\*high expression of CLDN18.2 and PDAC preferentially enrolled \\*\\*\\*moderate to high expression of CLDN18.2). For participants with previous anti-CLDN18.2 treatment (including but not limited to monoclonal antibodies, ADCs, CAR-T, etc.), tumor samples should be obtained post anti-CLDN18.2 therapy for CLDN18.2 expression evaluation.\n\nInclusion Criteria for Phase Ia Part 3 1L G\u002FGEJ AC Cohort:\n\n1. Participants with histopathologically confirmed unresectable locally advanced or metastatic G\u002FGEJ AC who has not received previous systemic therapy. (For Safety Lead-in stage, participants who has received previous systemic therapy are permitted.) A prior (neo)adjuvant systemic therapy completed within 6 months prior to disease relapse or progression will be considered as having received previous systemic therapy.\n2. Confirmed Her 2-negative (defined as IHC 0 or 1+, or IHC 2+ and negative by in situ hybridization) disease.\n3. Confirmed combined positive score (CPS) \\\u003C5 as determined by local IHC testing.\n4. Participants must not have previously received topoisomerase inhibitor-based antibody-drug conjugate(s), unless given peri-operatively without evidence of resistance.\n5. Participants must not have previously received anti-CLDN18.2 therapy.\n6. \\*CLDN18.2-positive confirmed by pathological examination by central laboratory (For Dose optimization stage, G\u002FGEJ AC enrolled participants with Claudin18.2 immunohistochemical membrane staining intensity 2+\u002F3+ in ≥50% of tumor cells).\n\nInclusion Criteria for Phase Ia Part 3 1L PDAC Cohort:\n\n1. Participants with histopathologically confirmed metastatic PDAC who has not received previous systemic therapy in the metastatic setting. (For Safety Lead-in stage, participants who has received previous systemic therapy are permitted.) A prior (neo)adjuvant systemic therapy completed within 12 months prior to disease relapse or progression will be considered as having received previous systemic therapy.\n2. Participants must not have previously received anti-CLDN18.2 therapy.\n3. Participants must not have previously received topoisomerase inhibitor-based antibody-drug conjugate(s), unless given peri-operatively without evidence of resistance.\n4. \\*CLDN18.2-positive confirmed by pathological examination by central laboratory (For Dose optimization stage, PDAC enrolled # specified expression of CLDN 18.2)\n\nInclusion Criteria for Phase Ib Cohort A:\n\n1. Histopathologically confirmed unresectable locally advanced or metastatic G\u002FGEJ AC.\n2. Have received at least 2 lines of systemic therapy \\[anti-PD-(L)1 + platinum, fluoropyrimidines, paclitaxel\u002Fdocetaxel, or irinotecan; participants with HER2 overexpression (defined as 3 + or 2 + by immunohistochemistry and ISH +) must have received anti-HER2 therapy, and participants who have not received prior anti-PD-(L)1 or anti-HER2 therapy must have had a contraindication or reasonable reason for no benefit\\] and have had disease progression.\n3. High expression of \\*\\*CLDN18. 2 was confirmed by pathological examination.\n\nInclusion Criteria for Phase Ib Cohort B:\n\n1. Histopathologically confirmed unresectable locally advanced or metastatic G\u002FGEJ AC.\n2. Disease progression after first-line standard therapy (HER2-overexpressing participants must have received prior anti-HER2 therapy unless contraindicated or justified non-benefit).\n3. Confirmed \\* CLDN18.2-positive by histopathological examination.\n\nInclusion Criteria for Phase Ib Cohort C:\n\n1. Histopathologically confirmed unresectable locally advanced or metastatic PDAC.\n2. Disease progression after at least one prior systemic therapy.\n\nInclusion criteria for Phase Ib Cohort D:\n\n1. Histopathologically confirmed unresectable locally advanced or metastatic BTC.\n2. Disease progression after at least one prior systemic therapy.\n3. Confirmed \\* CLDN18.2-positive by histopathological examination.\n\nNotes:\n\n* CLDN18.2-positive: defined as ≥ 1% of tumor cells with membranous staining of any intensity in tumor tissue by immunohistochemistry, when tested previously, at the study site, or at the central laboratory.\n\n  * High expression of CLDN18. 2: Claudin18.2 immunohistochemical membrane staining intensity ≥ 2 + in ≥ 75% of tumor cells.\n\n    * Moderate to high expression of CLDN18.2: Claudin18.2 immunohistochemical membrane staining intensity ≥ 2 + in ≥ 40% of tumor cells.\n\n      * Specified expression of CLDN18.2: Claudin18.2 immunohistochemical membrane staining intensity 1+\u002F2+\u002F3+ in ≥50% of tumor cells.\n\nExclusion Criteria:\n\nExclusion criteria common to Phases Ia and Ib:\n\n1. Is participating in another interventional clinical study other than an observational (non-interventional) clinical study or is in the survival follow-up phase of an interventional study.\n2. Has received the last dose of antineoplastic therapy within 4 weeks or 5 half-lives of an antineoplastic therapy (whichever is shorter) prior to the first dose of study drug.\n3. Plans to receive other anti-tumor therapy during treatment with the study drug \\[palliative radiotherapy for symptomatic relief (e.g., pain) that does not affect response assessment is allowed\\].\n4. Has received a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of study drug.\n5. Toxicities due to prior therapy that have not recovered to Grade 0 or 1 per NCI CTCAE v5.0 prior to the first dose of study drug (excluding alopecia, asthenia, hyperpigmentation, and other conditions with no safety risk per the judgment of the investigator).\n6. Has undergone major surgical procedure (craniotomy, thoracotomy, laparotomy or others per the investigator, excluding needle biopsy) or has unhealed wounds, ulcers, or bone fracture within 4 weeks prior to the first dose of study drug; Or plans to undergo major surgery during the study period; Note: Local surgical treatment of isolated lesions for palliative purposes is acceptable.\n7. Has gastric pyloric obstruction and\u002For persistent recurrent vomiting (≥ 3 episodes in 24 hours).\n8. Has a history of gastrointestinal perforation and\u002For fistula within 6 months that has not resolved surgically prior to the first dose of study drug.\n9. Has symptomatic central nervous system metastases. Participants with asymptomatic brain metastases (i.e., no neurological symptoms, no need for glucocorticoid treatment, all brain metastasis ≤ 1. 5 cm) or stable symptoms after treatment of brain metastases must meet all of the following criteria to participate in the study: no metastasis in the midbrain, pons, cerebellum, meninges, medulla oblongata or spinal cord; Stable clinical status for at least 4 weeks with definitive clinical evidence of no new or enlarging brain metastasis and discontinuation of corticosteroids and anticonvulsants for at least 2 weeks prior to the first dose of study drug. Note: lesions of the central nervous system will not be considered as a target lesion\n10. Has a history of pneumonitis requiring corticosteroids therapy, or a history of interstitial lung disease, non-infectious pneumonitis, severely impaired lung function or uncontrolled lung disease, such as pulmonary fibrosis, severe radiation pneumonitis, acute lung injury, or suspected of having the above diseases during the screening period.\n11. Has uncontrolled medical conditions, such as:\n12. Active or clinically uncontrolled serious infection requiring treatment with systemic anti-infectives (antibiotics, antivirals, or antifungals) within 1 week prior to the first dose of study drug, including but not limited to the infection of respiratory tract, urinary system, biliary tract infection, etc.\n13. Participants infected with human immunodeficiency virus (HIV) (HIV 1\u002F2 antibody positive).\n14. Acute or chronic active hepatitis B (defined as hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody positive (HBcAb) with hepatitis B virus DNA copies ≥ 104 copies\u002FmL or ≥ 2000 IU\u002FmL or above the lower limit of detection) or acute or chronic active hepatitis C \\[hepatitis C virus antibody (HCVAb) positive with HCV RNA \\> 103 copies\u002FmL\\]. Participants whose test results are below the above criteria after receiving antiviral therapy with nucleotides, or participants with positive serology but negative HCV-RNA test result are eligible.\n15. Has active pulmonary tuberculosis, is being treated with anti-tuberculosis therapy or having received anti-tuberculosis therapy within 1 year prior to the first dose of study drug.\n16. Has active syphilis or latent syphilis requiring treatment.\n17. Has symptomatic congestive heart failure (New York Heart Association classification NYHA class II-IV), symptomatic or uncontrolled arrhythmia, QTc interval \\> 480 ms, or personal or family history of congenital long\u002Fshort QT syndrome.\n\n    For part 3 1L G\u002FGEJ AC and 1L PDAC cohort, the QTc should be calculated based on the average of triplicate screening ECG (using Appendix 4 Calculation Formula of QTcF)\n18. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg) by standard treatment.\n19. Has one or more arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, etc., within 6 months prior to the first dose of study drug.\n20. Has received stent implantation in tracheal or digestive tract.\n21. Has symptomatic pleural, ascites, or pericardial effusion requiring intervention (e.g., drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy \\[CART\\]). Asymptomatic participants with a small amount of pleural effusion, ascites or pericardial effusion on imaging are allowed. (Drainage and CART are not allowed within 2 weeks prior to screening assessment).\n22. Has esophageal or gastric varices that require immediate intervention (e.g., ligature or sclerotherapy) or are considered to be at high risk for bleeding in the opinion of the investigator or consulting gastroenterologist or hepatologist. Participants with evidence of portal hypertension (including splenomegaly on imaging) or a history of prior variceal bleeding must undergo endoscopic evaluation within 3 months prior to the first dose of study drug.\n23. Has one or more life-threatening bleeding event or Grade 3 or 4 gastrointestinal\u002Fvariceal bleeding requiring blood transfusion, endoscopic or surgical treatment within 3 months prior to the first dose of study drug\n24. Has a history of deep vein thrombosis, pulmonary embolism, or any other serious venous thromboembolism within 3 months prior to the first dose of study drug (implantable venous access port or catheter-derived thrombosis, or superficial vein thrombosis is not considered \"serious\" venous thromboembolism).\n25. Has hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh B or more severe cirrhosis.\n26. Has complete or incomplete intestinal or bowel obstruction at the time of screening or a history of complete or incomplete intestinal or bowel obstruction within 3 months prior to first dose, or is at risk of intestinal perforation (including but not limited to acute diverticulitis, history of intra-abdominal abscess), or a history of any of the following disease: inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small bowel resection with concurrent chronic diarrhea), Crohn's disease, ulcerative colitis, and chronic diarrhea.\n27. Has other acute or chronic disease or laboratory abnormality that may result in increased risk associated with study participation or study drug administration, or interfere with the interpretation of study results, and is considered unfit for this study per the Investigator's judgement.\n28. Has a neurological or psychiatric illness or a social situation that affects compliance with study requirements, significantly increases the risk of AE, or affects the participant's ability to provide written ICF.\n29. Has a history of other primary malignancies, with the following exceptions:\n30. Curatively treated malignancy with no known active disease for ≥ 2 years prior to study enrollment and is at minimal risk of recurrence;\n31. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease recurrence;\n32. Adequately treated carcinoma in situ with no evidence of disease recurrence.\n33. Has a known history of immunodeficiency.\n34. Has a history of allogeneic organ transplantation and history of allogeneic hematopoietic stem cell transplantation.\n35. Has a history of severe allergic reaction to other monoclonal antibodies and\u002For hypersensitivity to any of the formulation components of IBI343 or mFOLFOX or Irinotecan or liposomal Irinotecan (For phase 1a part 3 1L G\u002FGEJ AC and 1L PDAC cohort).\n36. Female participants who are pregnant or lactating.\n37. Has other conditions considered not eligible to participate in this study per the Investigator's judgement.\n38. Has known dihydropyrimidine dehydrogenase deficiency (DPD). (NOTE: Screening for DPD deficiency should be conducted per local requirements.)\n39. Has known peripheral sensory neuropathy \\> grade 1 unless the absence of deep tendon reflexes is the sole neurological abnormality.",{"count":349,"type":23},470,[26],"This is a Phase Ia\u002FIb, multicenter, open-label, first-in-human study to evaluate the safety, tolerability, PK, and efficacy of IBI343 in participants with locally advanced unresectable or metastatic solid tumors. It is planned to be carried out in different countries or regions such as China, Australia and US.\n\nThere are three parts in phase Ia. Part 1 includes dose escalation and expansion phase and part 2 is designed for dose optimization for IBI343 monotherapy.\n\nPart 3 1L G\u002FGEJ AC and 1L PDAC cohorts will include an initial safety lead-in stage to confirm the tolerability of IBI343 in combination with chemotherapy in 1L PDAC and G\u002FGEJ AC, followed by a randomized dose-optimization stage designed to further characterize safety, pharmacokinetics, and preliminary efficacy to inform selection of the recommended Phase 3 dose.",[353],"Locally Advanced Unresectable or Metastatic Solid Tumors","2026-04-28",{"date":356,"type":35},"2026-05-04",{"date":358,"type":35},"2022-10-26",{"date":360,"type":23},"2027-12-31",{"name":41,"class":42},39,{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":370,"targetDuration":4,"studyType":24,"phases":372,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":378,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":43},"100635556","phase-1-study-to-evaluate-the-safety-tolerability-and-how-ibi3013-is-taken-up-and-processed-by-the-body-in-healthy-volunteers-after-single-dose-administration-and-in-non-segmental-vitiligo-patients-and-alopecia-areata-patients-after-multiple-dose-administration-100635556","NCT07554222","Study to Evaluate the Safety, Tolerability and How IBI3013 is Taken up and Processed by the Body in Healthy Volunteers After Single-dose Administration, and in Non-segmental Vitiligo Patients and Alopecia Areata Patients After Multiple-dose Administration","Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single-dose Administration of IBI3013 in Healthy Adult Trial Participants and Multiple-dose Administration in Active Non-segmental Vitiligo Trial Participants and Severe Alopecia Areata Trial Participants - a Randomized, Double-blind, Placebo-controlled, Dose-escalation Study","Inclusion criteria\n\n1. Part 1 - Healthy trial participants: Understand and voluntarily sign the informed consent form;\n2. Part 1 - Healthy trial participants: Age between 18-45 years (inclusive), male or female;\n3. Part 1 - Healthy trial participants: Weight between 50-120 kg (inclusive), and BMI between 17.0-28.0 kg\u002Fm2 (inclusive);\n4. Part 2 - Active non-segmental vitiligo trial participants: 18-65 years old (inclusive), male;\n5. Part 2 - Active non-segmental vitiligo trial participants: Diagnosed with non-segmental vitiligo for ≥3 months and \\\u003C2 years;\n6. Part 2 - Active non-segmental vitiligo trial participants: Total affected BSA 3-50%, and facial affected BSA ≥ 0.5%; T-VASI 3-50 (inclusive), and F-VASI ≥0.5; ≥1 active lesion;\n7. Part 2 - : Male participants of reproductive potential agree to use highly effective contraception and avoid sperm donation for 6 months after the last dose.\n8. Part 2 - Severe alopecia areata trial participants: 18-60 years old (inclusive), male;\n9. Part 2 - Severe alopecia areata trial participants: Meet the following severe alopecia areata criteria: a) SALT ≥50% (i.e., AA-IGA 3-4 grade) b) No spontaneous remission in the past 6 months (spontaneous remission defined as SALT reduction by ?10 points) c) Current duration of severe alopecia areata ≥6 months and \\\u003C4 years;\n10. All participants: Participants of reproductive potential agree to use highly effective contraception and avoid sperm or egg donation for 6 months after the last dose.\n\nExclusion criteria\n\n1. All participants: Those who are allergic to any component of IBI3013;\n2. All participants: Those who cannot tolerate subcutaneous injection;\n3. All participants: History of live or attenuated live vaccine within 30 days prior to randomization, or expected to receive such vaccines during the study period until 3 months after the last dose of the investigational drug;\n4. All participants: Donated blood or lost ≥400 mL of blood within 3 months before screening;\n5. All participants: History of herpes zoster or disseminated herpes simplex (single episode), or recurrent (more than one episode) localized herpes zoster;\n6. All participants: Known history of active tuberculosis or clinical manifestations suggestive of tuberculosis, or positive interferon-gamma release assay unsuitable for participation;\n7. All participants: Abnormal vital signs, serum virology tests, laboratory tests, ECG, or other examinations with clinical significance, and deemed unsuitable for the study by the investigator;\n8. All participants: Received specific treatment within the time frame specified in the protocol, or participated in other investigational drug studies within the specified time;\n9. All participants: History of drug abuse, drug dependence, or positive drug screening results during the screening period within 12 months;\n10. All participants: Pregnant or lactating women;\n11. All participants: Coexisting diseases at screening or previously, deemed unsuitable for clinical trials;\n12. Active non-segmental vitiligo\u002FSevere alopecia areata trial participants: Previous or coexisting diseases, which may affect the efficacy or safety evaluation of the study as assessed by the investigator;\n13. Active non-segmental vitiligo trial participants: Coexisting segmental, undetermined type, or mixed-type vitiligo, or other skin pigmentation disorders, or other skin-related abnormalities that may affect the assessment of the study;\n14. Severe alopecia areata trial participants: Currently diagnosed with primary diffuse AA or ophiasis AA; or other types of hair loss that may interfere with AA evaluation;\n15. Severe alopecia areata trial participants: Previously received oral JAK inhibitors with poor response; 16. Severe alopecia areata trial participants: Acute myocardial infarction, unstable ischemic heart disease, stroke, chronic heart failure (NYHA class III\u002FIV) within 12 weeks prior to screening; or previous history of deep vein thrombosis, or high risk of deep vein thrombosis as assessed by the investigator; or severe neuropsychiatric disorder, deemed unsuitable for the study by the investigator.",{"count":371,"type":23},160,[26],"A multicenter clinical study to evaluate the safety, PK characteristics, immunogenicity characteristics, and PD characteristics of IBI3013 in healthy trial participants and active non-segmental vitiligo trial participants and severe alopecia areata trial participants. The study is divided into 2 parts, with Part 1 involving healthy trial participants lasting up to 24 weeks, and Part 2 involving active non-segmental vitiligo trial participants and severe alopecia areata trial participants lasting up to 48 weeks.",[375,376,377],"Healthy","Active Non-segmental Vitiligo","Severe Alopecia Areata",{"date":354,"type":35},{"date":380,"type":35},"2026-04-18",{"date":382,"type":23},"2028-12-31",{"name":41,"class":42},{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":117,"enrollmentInfo":391,"targetDuration":4,"studyType":24,"phases":393,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":43},"100635754","phase-1-study-of-ibi3016-in-people-with-mild-or-moderate-hypertension-patients-100635754","NCT07556796","Study of IBI3016 in People With Mild or Moderate Hypertension Patients","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamic Features of a Single Subcutaneous Administration of IBI3016 in Patients With Mild or Moderate Hypertension in China","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Males or females aged 18 to 75 years. 3 Diagnosed primary hypertension who have not been taking anti-hypertensive medication within 4 weeks prior to informed consent.\n\n4.Mean sitting SBP ≥140 mmHg and \\\u003C 170 mmHg measured by OBPM. 5.Participants able to understand and comply with study procedures.\n\nExclusion Criteria:\n\n1. Known history of secondary hypertension.\n2. Orthostatic hypotension.\n3. Laboratory parameter assessments outside of range at screening：\n\n   * Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \\> 2× Upper Limit of Normal (ULN)\n   * Total Bilirubin \\> 1.5× ULN\n   * International Normalized Ratio (INR) \\> 2.0\n   * Serum Potassium \\> 5 mmol\u002FL\n   * Estimated Glomerular Filtration Rate (eGFR) ≤ 45 mL\u002Fmin\u002F1.73m²\n   * QTcF \\> 480 ms\n4. Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.\n5. Current or history of intolerance to ACEi and\u002For ARBs.\n6. Acute myocardial infarction (AMI), unstable angina, percutaneous coronary intervention (PCI) , coronary artery bypass graft (CABG), ischemic or hemorrhagic stroke, transient ischemic attack, or clinically significant cardiac arrhythmias within 6 months prior to screening, or a previous diagnosis of decompensated heart failure or New York Heart Association (NYHA) grade III or IV heart failure.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply",{"count":392,"type":23},30,[26],"A Phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics, and pharmacodynamic characteristics of a single subcutaneous dose of IBI3016 in Chinese patients with mild to moderate hypertension.",[396],"Hypertension","2026-04-22",{"date":399,"type":35},"2026-04-29",{"date":401,"type":23},"2026-05-15",{"date":403,"type":23},"2027-10-16",{"name":41,"class":42},{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":117,"enrollmentInfo":412,"targetDuration":4,"studyType":24,"phases":414,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":43},"100635230","phase-1-a-study-of-ibi3033-in-moderate-to-severe-atopic-dermatitis-100635230","NCT07549984","A Study of IBI3033 in Moderate-to-Severe Atopic Dermatitis","A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of IBI3033 in Participants With Moderate-to-Severe Atopic Dermatitis","Inclusion Criteria:\n\n1. Ability to understand and sign written informed consent prior to any study procedures and willingness to comply with study requirements throughout the study.\n2. Age between 18 and 75 years old (inclusive).\n3. Body weight ≥40 kg, with a Body Mass Index (BMI) between 18 and 35 kg\u002Fm² (inclusive).\n4. Participants of childbearing potential and their partners must agree to strictly follow contraceptive measures specified in the protocol during the study and for 6 months after study completion.\n\n   At the time of screening, meet the diagnostic criteria for atopic dermatitis according to the 2014 American Academy of Dermatology consensus, and have been diagnosed with AD for at least 12 months.\n5. At screening and randomization, participants must have an EASI score ≥16, vIGA-AD score ≥3, involved body surface area (BSA) ≥10%, and baseline PP-NRS ≥4.\n6. History of inadequate response to topical therapy within the past 12 months, or documented medical reasons making topical therapy unsuitable (e.g., severe adverse reactions or safety concerns).\n\nExclusion Criteria:\n\n1. Clinically significant diseases that may affect safety or study participation, including but not limited to psychiatric, CNS, cardiovascular, digestive, respiratory, urinary, hematologic, or metabolic disorders.\n2. Known history of active tuberculosis or clinically suspected tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.); or chest imaging suggestive of suspected tuberculosis; or any other clinical evidence of latent tuberculosis.\n3. History of malignant tumors, except for surgically removed or cured localized basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin.\n4. History of severe systemic allergic reactions (e.g., anaphylaxis, laryngeal edema).\n5. Fainting at the sight of needles, blood, or inability to tolerate intravenous puncture.\n6. Pregnant or breastfeeding women, or female participants who test positive for pregnancy during screening or at randomization.\n7. Receipt of other investigational drugs within 3 months or 5 half-lives before randomization (whichever is longer), or current participation in another clinical trial.\n8. Had a serious infection (defined as requiring hospitalization or intravenous anti-infective therapy) or trauma within the 3 months prior to randomization, or a history of surgery within 3 months, or an infection requiring oral medication within 1 month, or plans to undergo surgery during the study period.\n9. Receipt of any live vaccines (except influenza vaccine) within 1 month before randomization, or planning to receive vaccination during the study.\n10. History of parasitic infections within 6 months before screening, or planning to travel to parasite-endemic countries\u002Fregions in Africa, South America, and southern parts of Asia (including Southeast Asia, India, Nepal) within 6 months after study completion.",{"count":413,"type":23},16,[26],"This is a Phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study designed to evaluate the safety, tolerability, and pharmacokinetics of IBI3033 in subjects with moderate-to-severe atopic dermatitis (AD). Approximately 16 eligible adult participants will be enrolled and sequentially assigned to one of two dose cohorts. Within each cohort, participants will be randomized in a 3:1 ratio to receive IBI3033 or matching placebo. The study consists of a screening period (up to 4 weeks), a 12-week treatment period, and a 4-week safety follow-up period. The primary objective is to assess safety and tolerability based on the incidence of adverse events and serious adverse events. Secondary objectives include characterization of pharmacokinetics and immunogenicity. Exploratory assessments include pharmacodynamic biomarkers and preliminary efficacy outcomes such as changes in Eczema Area and Severity Index (EASI) and Investigator's Global Assessment (vIGA-AD) scores.",[123],"2026-04-19",{"date":419,"type":35},"2026-04-24",{"date":421,"type":23},"2026-04-30",{"date":423,"type":23},"2027-03-25",{"name":41,"class":42},{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":24,"phases":434,"briefSummary":435,"conditions":436,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":443,"locationsCount":43},"100618385","phase-2-a-study-to-evaluate-efficacy-and-safety-of-ibi356-in-participants-with-moderate-to-severe-atopic-dermatitis-100618385","NCT07330934","A Study to Evaluate Efficacy and Safety of IBI356 in Participants With Moderate to Severe Atopic Dermatitis","A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of IBI356 in Adult Participants With Moderate to Severe Atopic Dermatitis","Inclusion Criteria:\n\n1. Able to understand and sign the informed consent form (ICF);\n2. Aged ≥ 18 years, male or female;\n3. Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria);\n4. EASI score of 16 or higher at baseline, vIGA-AD of 3 or 4 at baseline, AD involvement of 10% or more of BSA at baseline, weekly average of daily PP-NRS of ≥ 4 at baseline;\n5. Participants with documented inadequate response to topical medications or for whom topical treatments are otherwise medically inadvisable.\n\nExclusion Criteria:\n\n1. Presence of diseases that may affect the safety or efficacy, including but not limited to psychistric disorders, central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, and hematological or metabolic system diseases.\n2. Known history of active tuberculosis or clinically suspected tuberculosis; or chest imaging suggesting evidence of suspected tuberculosis; or any other clinical evidence of latent tuberculosis.\n3. Has known or suspected helminth or other parasitic infection.\n4. History of malignancy, except excised or curatively treated localized basal cell carcinoma (BCC) or cutaneous squamous cell carcinoma (cSCC).\n5. History of severe drug allergy or anaphylaxis.\n6. Fainting, hemophobia, or inability to tolerate venipuncture.\n7. Women who are pregnant or breastfeeding, or female participants who have a positive pregnancy test at screening or randomization.\n8. Have received an organ or hematopoietic stem cell transplant.\n9. Positive HBsAg; or positive HBcAb with positive HBV-DNA; or positive hepatitis C antibody with positive HCV-RNA; or positive treponema pallidum antibody; or positive HIV serology at screening.\n10. Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit.\n\nThe above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.",{"count":433,"type":23},403,[77],"This is a multi-center, randomized, double-blind, parallel, placebo-controlled phase 2 clinical study. A total of 403 adult participants with moderate to severe AD are planned to be enrolled to evaluate efficacy, safety, PK characteristics, immunogenicity, and changes in PD characteristics of IBI356.",[123],"2026-03-10",{"date":439,"type":35},"2026-03-11",{"date":441,"type":35},"2025-12-31",{"date":360,"type":23},{"name":41,"class":42},{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":117,"enrollmentInfo":451,"targetDuration":4,"studyType":24,"phases":452,"briefSummary":453,"conditions":454,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":43},"100623625","phase-2-a-proof-of-concept-study-of-ibi3002-in-patients-with-moderate-to-severe-atopic-dermatitis-100623625","NCT07399067","A Proof-of-Concept Study of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis","A Randomized, Double-Blind, Placebo-Controlled, Multicenter Proof-of-Concept Study to Evaluate the Efficacy and Safety of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis","Inclusion Criteria:\n\n1. Ability to understand and sign written informed consent prior to any study procedures and willingness to comply with study requirements throughout the study.\n2. Age between 18 and 75 years old (inclusive).\n3. Body weight ≥40 kg, with a Body Mass Index (BMI) between 18 and 35 kg\u002Fm² (inclusive).\n4. Participants of childbearing potential and their partners must agree to strictly follow contraceptive measures specified in the protocol during the study and for 6 months after study completion.\n5. At the time of screening, meet the diagnostic criteria for atopic dermatitis according to the 2014 American Academy of Dermatology consensus, and have been diagnosed with AD for at least 12 months.\n6. At screening and randomization, participants must have an EASI score ≥16, vIGA-AD score ≥3, involved body surface area (BSA) ≥10%, and baseline PP-NRS ≥4.\n7. History of inadequate response to topical therapy within the past 12 months, or documented medical reasons making topical therapy unsuitable (e.g., severe adverse reactions or safety concerns).\n\nExclusion Criteria:\n\n1. Clinically significant diseases that may affect safety or study participation, including but not limited to psychiatric, CNS, cardiovascular, digestive, respiratory, urinary, hematologic, or metabolic disorders.\n2. Known history of active tuberculosis or clinically suspected tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.); or chest imaging suggestive of suspected tuberculosis; or any other clinical evidence of latent tuberculosis.\n3. History of malignant tumors, except for surgically removed or cured localized basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin.\n4. History of severe systemic allergic reactions (e.g., anaphylaxis, laryngeal edema).\n5. Fainting at the sight of needles, blood, or inability to tolerate intravenous puncture.\n6. Pregnant or breastfeeding women, or female participants who test positive for pregnancy during screening or at randomization.\n7. Receipt of other investigational drugs within 3 months or 5 half-lives before randomization (whichever is longer), or current participation in another clinical trial.\n8. Had a serious infection (defined as requiring hospitalization or intravenous anti-infective therapy) or trauma within the 3 months prior to randomization, or a history of surgery within 3 months, or an infection requiring oral medication within 1 month, or plans to undergo surgery during the study period.\n9. Receipt of any live vaccines (except influenza vaccine) within 1 month before randomization, or planning to receive vaccination during the study.\n10. History of parasitic infections within 6 months before screening, or planning to travel to parasite-endemic countries\u002Fregions in Africa, South America, and southern parts of Asia (including Southeast Asia, India, Nepal) within 6 months after study completion.",{"count":75,"type":23},[77],"The primary objective of this Phase 2 study is to evaluate the efficacy and safety of IBI3002 in patients with moderate to severe Atopic Dermatitis (AD).",[123],"2026-02-11",{"date":457,"type":35},"2026-02-13",{"date":459,"type":35},"2026-02-06",{"date":461,"type":23},"2027-05-27",{"name":41,"class":42},{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":117,"enrollmentInfo":470,"targetDuration":4,"studyType":24,"phases":472,"briefSummary":473,"conditions":474,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":481,"locationsCount":43},"100623856","phase-2-ibi363-as-neoadjuvant-therapy-in-resectable-stage-ii-iii-non-small-cell-lung-cancer-100623856","NCT07402070","IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer","A Phase II Study Evaluating the Efficacy and Safety of IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Males and Females, age ≥18 years and ≤75 years;\n2. Histologically or cytologically confirmed primary NSCLC:\n\n   * Stage II, IIIA or IIIB (N2) NSCLC (per AJCC8);\n   * No administration of any anti-NSCLC therapy in the pre-operative period;\n   * Be able to undergo the radical resection; Pulmonary function capacity capable of tolerating the proposed lung resection according to the surgeon.\n3. Participants without EGFR mutations or ALK translocation;\n4. PD-L1 expression: TPS≥1%\n5. At least 1 measurable lesion per RECISIT v1.1;\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;\n7. Adequate organ function confirmed at screening period.\n\nExclusion Criteria:\n\n1. Histologically confirmed the presence of small cell lung cancer, neuroendocrine carcinoma, sarcoma, salivary gland tumor, and mesenchymal tumor components, or mixed NSCLC with predominant squamous cell carcinoma features;\n2. Tumor invasion of surrounding important structures, which is symptomatic or medical intervention indicated;\n3. Pancoast tumor;\n4. Malignant tumor nodule in the contralateral lung lobe;\n5. Participants with known or suspected brain metastases or other distant metastases;\n6. Participants who received Chinese herbal medicines, proprietary Chinese medicines with anti-tumor indications, or immunomodulatory drugs within 2 weeks prior to the first dose of the study drug;\n7. Participants with a condition requiring systemic treatment with corticosteroids or is receiving any other form of immunosuppressive therapy within 7 days prior the first dose of the study drug;\n8. Clinically significant cardiovascular or cerebrovascular disease , or history of any thromboembolic event within 6 months prior to the first dose of the study drug;\n9. History of pneumonitis requiring corticosteroid therapy, or history of clinically significant lung diseases or severe impairment of pulmonary function or who are suspected to have these diseases by imaging during the screening period;\n10. Active or uncontrolled diseases or conditions;\n11. History of immunodeficiency disease; 12 Participants with active autoimmune disease requiring systemic treatment within 2 years prior to the first dose of the study drug.",{"count":471,"type":23},10,[77],"This is a Phase 2 study to evaluate the safety, and efficacy of IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer.",[475],"Resectable Stage II-III Non-small Cell Lung Cancer","2026-02-03",{"date":455,"type":35},{"date":479,"type":23},"2026-02-04",{"date":107,"type":23},{"name":41,"class":42},{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":24,"phases":491,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":503},"100591006","phase-1-ibi3014-in-participants-with-unresectable-locally-advanced-or-metastatic-solid-tumors-100591006","NCT06974812","IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors","A Phase 1\u002F2 Study of IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria\n\n* 1.Participants with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;\n* 2.Male or female participants ≥ 18 years old;\n* 3.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;\n* 4.Anticipated life expectancy of ≥ 12 weeks;\n* 5.Participants, both male and female, who are either not of childbearing potential or who agree to use at least one highly effective method of contraception during the study (begin from screening or within 2 weeks prior to the first dose, whichever comes first, and continue until 6 months after the last dose of study drug).\n* 6.Adequate bone marrow and organ function:\n* 7.Has at least 1 measurable lesion per RECIST v1.1(at least 1 evaluable lesion for dose participants in dose escalation part);\n* 8.Not a candidate for curable surgical resection or radical chemoradiation;\n\nExclusion Criteria\n\n* 1.Drugs and other treatments to be excluded;\n* 2.Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to Investigators' opinion) prior to first administration of the study drug;\n* 3.Prior use of Camptothecin-Derived agents (e.g., irinotecan, topotecan) or immune checkpoint inhibitor and documented adverse reaction which is severe and influence the safety assessment of participants.\n* 4.Allergic or hypersensitive to other monoclonal antibodies and\u002For Camptothecin Derivative based therapy, or any ingredients of IBI3014;\n* 5.Known symptomatic central nervous system (CNS) metastases. The following conditions could be considered enrollment: Participants with asymptomatic CNS metastases (which means no neural system syndromes, no need of corticosteroids treatment and diameter of metastases ≤ 1.5cm) or confirmed stable status according to Investigators' opinion after treatment, No midbrain, pons, cerebellum, meninges, medulla oblongata or spinal cord metastasis; and stable status for at least 4 weeks without new or enlarged metastases definitively confirmed by clinical evidence, and withdrawal of corticosteroids or anticonvulsant for at least 2 weeks prior to the first administration of study drug;\n* 6.History of pneumonitis requiring corticosteroids therapy, or history of clinically significant lung diseases (e.g. Interstitial lung disease, non-infectious pneumonia, or uncontrolled lung disease such as pulmonary fibrosis, severe radiation pneumonitis and acute lung injury) or who are suspected to have these diseases by imaging at screening period;\n* 7.Participants with a clinically significant (CS) cardiovascular disease or condition;\n* 8.Participants with a significant gastrointestinal disease or condition,\n* 9.Participants with biliary obstruction. Unless the blockage is treated locally, such as endoscopic stenting or percutaneous liver puncture and drainage, the total bilirubin is reduced below 1.5 times ULN;\n* 10.Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention;\n* 11.Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade B or more severe cirrhosis;\n* 12.Significant malnutrition, such as the need for intravenous fluids; Malnutrition corrected for more than 4 weeks prior to the first administration of study drug is allowed;\n* 13.Tumor invasion of surrounding important structures (such as mediastinal vessels, superior vena cava, trachea, esophagus, etc.) or at risk of gastrointestinal\u002Frespiratory fistula;\n* 14.Uncontrolled or clinically significant infections\n* 15.History of immunodeficiency disease, including congenital or acquired immunodeficiency diseases;\n* 16.Had a history of organ transplantation, allogeneic bone marrow transplantation or hematopoietic stem cell transplantation;\n* 17.Other uncontrolled active disease or acute or chronic diseases or abnormal laboratory test that may: increase risk of study participation or study drug administration, interfere with the interpretation of study results, and, disqualify the participant for study participation in the Investigator's judgment;\n* 18.History of other primary malignant tumors;\n* 19.Women who are considered pregnant or are lactating;\n* 20.Under neurological, psychiatric disorder or social condition that affects compliance with study requirements, significantly increases the risk of adverse events, or affects participants' ability to provide written informed consent;",{"count":490,"type":23},250,[26,77],"This is a phase 1\u002F2 multicenter, multi-regional, open-label, first-in-human study of IBI3014 in participants with unresectable locally advanced or metastatic solid tumors.",[494],"Unresectable Locally Advanced or Metastatic Solid Tumors","2026-01-26",{"date":497,"type":35},"2026-01-29",{"date":499,"type":35},"2025-04-18",{"date":501,"type":23},"2027-06-30",{"name":41,"class":42},3,{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":117,"enrollmentInfo":511,"targetDuration":4,"studyType":24,"phases":513,"briefSummary":514,"conditions":515,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":520,"leadSponsor":522,"locationsCount":43},"100620080","phase-2-a-dose-finding-study-of-ibi3016-in-mild-to-moderate-hypertensive-patients-100620080","NCT07352969","A Dose Finding Study of IBI3016 in Mild to Moderate Hypertensive Patients","A Randomized, Double-blind, Placebo-controlled, Multicenter, 24 Months Treatment Duration, Dose Finding Study, to Evaluate Efficacy, Safety and Pharmacodynamics of IBI3016 in Mild to Moderate Hypertensive Patients","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Males or females aged 18 to 75 years.\n3. Diagnosis of primary hypertension without anti-HTN medication or with one anti-HTN medication\n4. Mean sitting SBP ≥140 mmHg and \\\u003C 170 mmHg measured by OBPM.\n5. Participants able to understand and comply with study procedures.\n\nExclusion Criteria:\n\n1. Known history of secondary hypertension.\n2. Orthostatic hypotension.\n3. Laboratory parameter assessments outside of range at screening：\n\n   * Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \\> 2× Upper Limit of Normal (ULN)\n   * Total Bilirubin \\> 1.5× ULN\n   * International Normalized Ratio (INR) \\> 2.0\n   * Serum Potassium \\> 5 mg\u002FL\n   * Estimated Glomerular Filtration Rate (eGFR) ≤ 45 mL\u002Fmin\u002F1.73m²\n   * QTcF \\> 480 ms\n4. Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.\n5. Current or history of intolerance to ACEi and\u002For ARBs.\n6. Acute myocardial infarction (AMI), unstable angina, percutaneous coronary intervention (PCI) , coronary artery bypass graft (CABG), ischemic or hemorrhagic stroke, transient ischemic attack, or clinically significant cardiac arrhythmias within 6 months prior to screening. Any history of congestive heart failure.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply",{"count":512,"type":23},352,[77],"The purpose of this study is to evaluate the efficacy, safety and tolerability of IBI3016 or placebo, given subcutaneously, every 3 or 6 months, at different dose levels in patients with mild to moderate hypertension",[396],"2026-01-13",{"date":518,"type":35},"2026-01-20",{"date":459,"type":23},{"date":521,"type":23},"2029-03-27",{"name":41,"class":42},{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":4,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":18,"minAge":530,"maxAge":19,"enrollmentInfo":531,"targetDuration":4,"studyType":24,"phases":532,"briefSummary":533,"conditions":534,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":43},"100612563","phase-3-a-study-of-ibi362-in-chinese-adolescents-with-obesity-or-overweight-100612563","NCT07255209","A Study of IBI362 in Chinese Adolescents With Obesity or Overweight","A Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of IBI362 in Chinese Adolescents With Obesity or Overweight（GLORY-YOUNG）","Inclusion Criteria:\n\nParticipants must meet all of the following inclusion criteria to be enrolled:\n\nKey Inclusion Criteria：\n\n1. Male or female participants aged ≥12 years and \\\u003C18 years at the time of signing the informed consent\u002Fassent form.\n2. BMI at screening meeting the obesity criteria defined by \"WS\u002FT 586-2018 Screening for Overweight and Obesity in School-Age Children and Adolescents\" or meeting overweight criteria plus at least one weight-related comorbidity: prediabetes, type 2 diabetes, hypertension, dyslipidemia, fatty liver disease, or obstructive sleep apnea syndrome.\n3. Weight change \\\u003C5 kg after ≥12 weeks of diet and exercise alone before screening (per self\u002Fparental report).\n\nExclusion Criteria:\n\nKey Exclusion Criteria：\n\n1. Prior diagnosis of type 1 diabetes.\n2. Pre-pubertal participants (Tanner Stage I).\n3. History of (or planned) bariatric surgery (except liposuction\u002Fabdominoplasty or acupuncture for weight loss performed \\>1 year before screening).","12 Years",{"count":139,"type":23},[98],"The study is designed to assess the efficacy and safety of multiple doses of IBI362 in Chinese adolescent subjects with obesity or overweight. It plans to enroll 180 adolescents (aged ≥12 and \\\u003C18 years) who have failed to achieve a 5 kg weight reduction after at least 12 weeks of dietary and exercise intervention.",[535],"Adolescents With Obesity or Overweight With Weight-Related Comorbidities","2026-01-07",{"date":538,"type":35},"2026-01-08",{"date":540,"type":35},"2025-12-29",{"date":542,"type":23},"2028-10-31",{"name":41,"class":42},""]