[{"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:":543},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,42,0,25,[9,42,65,86,108,128,150,169,193,215,237,257,278,299,318,338,358,380,399,421,442,463,481,502,522],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100635925","phase-1-safety-and-preliminary-activity-of-bi115-in-advanced-sclc-100635925",false,"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.","ALL","18 Years","75 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","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",[28],"Small Cell Lung Cancer (SCLC)","RECRUITING","2026-06-02",{"date":32,"type":33},"2026-06-04","ACTUAL",{"date":35,"type":33},"2026-05-21",{"date":37,"type":22},"2030-03-30",{"name":39,"class":40},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":41},"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":50,"type":22},389,[52],"PHASE2","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.",[55,56,57],"CLDN18.2 Positive","Gastric\u002FGastroesophageal Junction Adenocarcinoma","Pancreatic Ductal Adenocarcinoma",{"date":59,"type":33},"2026-06-03",{"date":61,"type":33},"2026-04-20",{"date":63,"type":22},"2028-03-31",{"name":39,"class":40},{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":41},"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":73,"type":22},90,[52],"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.",[55,77,78],"Primary Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","2026-05-29",{"date":30,"type":33},{"date":82,"type":33},"2026-04-17",{"date":84,"type":22},"2031-06-30",{"name":39,"class":40},{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":41},"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":94,"type":22},255,[96],"PHASE3","The purpose of this study is to evaluate how well IBI3003 works when compared with the investigator's choice regimen (DPd or PVd)",[99],"Relapsed or Refractory Multiple Myeloma","NOT_YET_RECRUITING","2026-05-28",{"date":59,"type":33},{"date":104,"type":22},"2026-06-05",{"date":106,"type":22},"2029-12-31",{"name":39,"class":40},{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":41},"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":116,"type":22},66,[25],"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.",[120],"Thyroid Eye Disease","2026-05-27",{"date":59,"type":33},{"date":124,"type":22},"2026-05-30",{"date":126,"type":22},"2027-12-28",{"name":39,"class":40},{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":41},"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":136,"type":22},336,[96],"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",[140,141,142],"Overweight","Obesity","Hypertensive","2026-05-24",{"date":121,"type":33},{"date":146,"type":33},"2026-04-23",{"date":148,"type":22},"2027-04-15",{"name":39,"class":40},{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":23,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":41},"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":158,"type":22},282,[25,52],"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.",[162],"Solid Tumor",{"date":101,"type":33},{"date":165,"type":22},"2026-06-01",{"date":167,"type":22},"2028-06-30",{"name":39,"class":40},{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":176,"sex":177,"minAge":18,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":23,"phases":181,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":41},"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.",true,"MALE","45 Years",{"count":180,"type":22},144,[25],"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",[184],"Healthy Person","2026-05-11",{"date":187,"type":33},"2026-05-15",{"date":189,"type":22},"2026-05-08",{"date":191,"type":22},"2027-08-31",{"name":39,"class":40},{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":23,"phases":202,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":214},"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":201,"type":22},470,[25],"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.",[205],"Locally Advanced Unresectable or Metastatic Solid Tumors","2026-04-28",{"date":208,"type":33},"2026-05-04",{"date":210,"type":33},"2022-10-26",{"date":212,"type":22},"2027-12-31",{"name":39,"class":40},39,{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":176,"sex":17,"minAge":18,"maxAge":222,"enrollmentInfo":223,"targetDuration":4,"studyType":23,"phases":225,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":41},"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.","80 Years",{"count":224,"type":22},160,[25],"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.",[228,229,230],"Healthy","Active Non-segmental Vitiligo","Severe Alopecia Areata",{"date":206,"type":33},{"date":233,"type":33},"2026-04-18",{"date":235,"type":22},"2028-12-31",{"name":39,"class":40},{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":244,"targetDuration":4,"studyType":23,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":254,"leadSponsor":256,"locationsCount":41},"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":245,"type":22},30,[25],"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.",[249],"Hypertension","2026-04-22",{"date":252,"type":33},"2026-04-29",{"date":187,"type":22},{"date":255,"type":22},"2027-10-16",{"name":39,"class":40},{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":41},"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":265,"type":22},16,[25],"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.",[269],"Atopic Dermatitis","2026-04-19",{"date":272,"type":33},"2026-04-24",{"date":274,"type":22},"2026-04-30",{"date":276,"type":22},"2027-03-25",{"name":39,"class":40},{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":285,"targetDuration":4,"studyType":23,"phases":287,"briefSummary":288,"conditions":289,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":41},"100629383","phase-3-ibi306-monotherapy-in-non-familial-hypercholesterolemia-and-mixed-hyperlipidemia-100629383","NCT07473960","IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia","A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of IBI306 Monotherapy in Participants With Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia (CREDIT-5)","Inclusion Criteria:\n\n1. Male or female, ≥18 and ≤75 years of age on the day of signing informed consent.\n2. Fasting LDL-C ≥ 2.6 mmol\u002FL and \\\u003C 4.9 mmol\u002FL measured in a local laboratory at screening and randomization.\n3. Fasting triglyceride (TG) ≤ 5.64 mmol\u002FL measured in a local laboratory at screening and randomization.\n4. According to the 2023 Chinese Guidelines for the Management of Blood Lipids, the 10-year risk of atherosclerotic cardiovascular disease is assessed as low or moderate (\\\u003C 10%).\n5. Understand the study-related procedures and methods, and voluntarily participate in the study and sign the informed consent form.\n\nExclusion Criteria:\n\n1\\. History of any of the following medical or treatment conditions:\n\n1. Known allergies to the study drugs or their components, or severe allergic reactions to other antibody drugs.\n2. Previously diagnosed as ASCVD, including acute coronary syndrome, stable coronary heart disease, post-revascularization, ischemic cardiomyopathy, ischemic stroke, transient ischemic attack, peripheral atherosclerotic disease, etc.\n3. Confirmed or suspected familial hypercholesterolaemia according to UK Simon Broome criteria.\n4. History of acute or chronic heart failure with New York Heart Association (NYHA) class III or IV, or left ventricular ejection fraction \\\u003C 40% within 3 months prior to screening.\n5. Previous diagnosis of severe arrhythmia, such as recurrent and symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular rate, or supraventricular tachycardia poorly controlled by medication, etc.\n6. Poorly controlled hypertension, defined as sitting systolic blood pressure (SBP) ≥ 160 mmHg or diastolic blood pressure (DBP) ≥ 100 mmHg at screening or randomization.\n7. Previous diagnosis of nephrotic syndrome, severe liver disease, Cushing's syndrome, and other diseases that significantly affect blood lipid levels.\n8. History of type 1 diabetes mellitus, or type 2 diabetes mellitus with one of the following: (1) glycosylated hemoglobin (HbA1c) ≥ 8.5% at screening; (2) severe hypoglycemia within 6 months prior to screening; (3) insulin injection ≥ 2 times per day prior to screening.\n9. History of malignancy within 5 years prior to screening.\n10. Treatment with a PCSK9 monoclonal antibody within 6 months prior to screening or treatment with inclisiran prior to screening.\n11. Participation in a clinical study of any medical device or other drug within 3 months prior to screening (except for screening failure), or less than 5 half-lives from the most recent dose of the investigational drug at screening.\n12. Treatment with systemic cyclosporine within 3 months prior to screening.\n13. Long-term continuous (≥ 7 days) or multiple (≥ 3 times) systemic glucocorticoid therapy within 3 months prior to screening (except for topical, intraocular, intranasal, inhaled, or intra-articular injection).\n14. Treatment with weight-loss drugs or bariatric surgery within 3 months prior to screening.\n15. History of drug or alcohol abuse prior to screening. Average weekly alcohol intake: more than 21 units for males and more than 14 units for females (1 unit = 360 mL of beer, or 150 mL of red wine, or 45 mL of distilled spirits\u002Fwhite wine).\n\n2\\. Paricipants whose laboratory test parameters meet any of the following criteria at screening or randomization:\n\n1. Estimated glomerular filtration rate ( eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m 2 using the MDRD formula.\n2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 × upper limit of normal (ULN), or total bilirubin \\> 1.5 × ULN.\n3. Creatine kinase (CK) \\> 3 × ULN.\n4. Hypothyroidism or hyperthyroidism, defined as thyroid-stimulating hormone (TSH) below the lower limit of normal or exceeding 1.5 times the ULN, respectively.\n5. Positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) and HBV DNA copy number ≥ 1.0 × 10 3 \u002FmL, or positive for hepatitis C antibody ( except for those who have received complete anti-hepatitis C treatment and whose HCV RNA is below the lower limit of detection ).\n6. Positive for human immunodeficiency virus (HIV) antibodies or syphilis-specific antibodies.\n\n3\\. Female participants of childbearing potential who did not use contraception within 4 weeks prior to screening, or male or female participants who did not agree to use contraception as specified in this protocol throughout the study and for 15 weeks after the last treatment.\n\n4\\. Female participants who are pregnant or lactating. 5. The investigator believes that the subject has poor compliance, or there are factors that may bring unacceptable safety risks or affect the study results.",{"count":286,"type":22},198,[96],"This is a multi-center, randomized, double-blind, placebo-controlled phase III clinical study evaluating the efficacy and safety of IBI306 monotherapy in Chinese Paricipants with non-familial hypercholesterolemia and mixed hyperlipidemia. Approximately 198 participants were planned to be enrolled in the study. The entire study period includes a screening period of no more than 2 weeks, a run-in period of 4 weeks, a double-blind treatment period of 12 weeks, and a safety follow-up period after the last treatment. Participants were required to maintain a stable and healthy lifestyle throughout the trial.",[290],"Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia","2026-04-13",{"date":293,"type":33},"2026-04-14",{"date":295,"type":33},"2026-04-01",{"date":297,"type":22},"2027-02-28",{"name":39,"class":40},{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":23,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":317,"locationsCount":41},"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":307,"type":22},403,[52],"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.",[269],"2026-03-10",{"date":313,"type":33},"2026-03-11",{"date":315,"type":33},"2025-12-31",{"date":212,"type":22},{"name":39,"class":40},{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":325,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":41},"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":326,"type":22},120,[52],"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).",[269],"2026-02-11",{"date":332,"type":33},"2026-02-13",{"date":334,"type":33},"2026-02-06",{"date":336,"type":22},"2027-05-27",{"name":39,"class":40},{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":345,"targetDuration":4,"studyType":23,"phases":347,"briefSummary":348,"conditions":349,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":41},"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":346,"type":22},10,[52],"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.",[350],"Resectable Stage II-III Non-small Cell Lung Cancer","2026-02-03",{"date":330,"type":33},{"date":354,"type":22},"2026-02-04",{"date":356,"type":22},"2030-12-31",{"name":39,"class":40},{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":23,"phases":367,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":379},"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":366,"type":22},250,[25,52],"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.",[370],"Unresectable Locally Advanced or Metastatic Solid Tumors","2026-01-26",{"date":373,"type":33},"2026-01-29",{"date":375,"type":33},"2025-04-18",{"date":377,"type":22},"2027-06-30",{"name":39,"class":40},3,{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":387,"targetDuration":4,"studyType":23,"phases":389,"briefSummary":390,"conditions":391,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":396,"leadSponsor":398,"locationsCount":41},"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":388,"type":22},352,[52],"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",[249],"2026-01-13",{"date":394,"type":33},"2026-01-20",{"date":334,"type":22},{"date":397,"type":22},"2029-03-27",{"name":39,"class":40},{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":17,"minAge":406,"maxAge":18,"enrollmentInfo":407,"targetDuration":4,"studyType":23,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":41},"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":408,"type":22},180,[96],"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.",[412],"Adolescents With Obesity or Overweight With Weight-Related Comorbidities","2026-01-07",{"date":415,"type":33},"2026-01-08",{"date":417,"type":33},"2025-12-29",{"date":419,"type":22},"2028-10-31",{"name":39,"class":40},{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":222,"enrollmentInfo":428,"targetDuration":4,"studyType":23,"phases":430,"briefSummary":432,"conditions":433,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":41},"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.",{"count":429,"type":22},92,[431],"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).",[120],"2025-11-24",{"date":436,"type":33},"2025-12-04",{"date":438,"type":22},"2025-12-30",{"date":440,"type":22},"2027-09-04",{"name":39,"class":40},{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":23,"phases":451,"briefSummary":452,"conditions":453,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":41},"100588158","phase-2-a-study-of-ibi362-in-participants-with-metabolic-dysfunction-associated-steatohepatitis-mash-100588158","NCT06937749","A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)","A Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy and Safety of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Inclusion Criteria:\n\n* Must be willing to participate in the study and provide written informed consent.\n* Male or female, age 18 years or older at the time of signing informed consent\n* Body mass Index (BMI) ≥25 kg\u002Fm²\n* Diagnosis of Metabolic dysfunction-associated steatohepatitis (MASH) (Non-alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) ≥ 4, with at least 1 point in steatosis, inflammation and ballooning each) and fibrosis stage F2 or F3 proven by a biopsy conducted during the screening period or by a historical biopsy conducted within the last 3 months prior to screening\n\nExclusion Criteria:\n\n1. Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs\n2. HbA1c\\>10%\n3. History or current other forms of chronic liver disease other than MASH\n4. Patients with positive Hepatitis B surface antigen (HBsAg). Patients with positive HBcAb will be eligible only when HBV DNA test negative at screening\n5. patients with HCV antibody positive.\n6. Patients with HIV antibody positive or syphilis specific antibodies positive (patients with non-specific antibody turned negative will be eligible)\n7. Model for End-stage Liver Disease(MELD) \\>12 or Child-Turcotte-Pugh(CTP) \\>6",{"count":450,"type":22},165,[52],"This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating the efficacy and safety of IBI362 in MASH subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 8-week screening period, a 60-week double-blind treatment period, and a 4-week follow-up period.",[454],"Metabolic Dysfunction-associated Steatohepatitis (MASH)","2025-11-17",{"date":457,"type":33},"2025-11-20",{"date":459,"type":33},"2025-07-01",{"date":461,"type":22},"2027-07-22",{"name":39,"class":40},{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":222,"enrollmentInfo":470,"targetDuration":4,"studyType":23,"phases":472,"briefSummary":473,"conditions":474,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":480,"locationsCount":41},"100601651","phase-3-a-clinical-study-to-evaluate-the-efficacy-and-safety-of-ibi311-in-subjects-with-inactive-thyroid-eye-disease-100601651","NCT07113262","A Clinical Study to Evaluate the Efficacy and Safety of IBI311 in Subjects With Inactive Thyroid Eye Disease","A Multicenter, Randomized, Double-masked, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of IBI311 in Subjects With Inactive Thyroid Eye Disease","Inclusion Criteria:\n\n1.At screening and baseline, the following diagnostic criteria for inactive TED were met:\n\n1. CAS of both eyes ≤ 2 points during the screening period and baseline;\n2. According to the subject's medical history, CAS of both eyes ≤ 2 points at least 6 months before screening, or according to the subject's chief complaint or medical history, with all of the following characteristics: no progression of proptosis and no new diplopia caused by TED at least 6 months before screening or no progression of diplopia caused by TED and no new inflammatory TED symptoms;\n3. According to the subject's chief complaint or medical history, the first TED diagnosis before screening was ≥ 2 years and \\\u003C 10 years.\n\n2.At baseline, the proptosis of the study eye was ≥20 mm. 3.If the subject is a female, she should be infertile or have a negative blood pregnancy test during the screening period and agree to take contraceptive measures from the screening period to 120 days after the last medication. If the subject is a male, he should agree to take contraceptive measures from the screening period to 120 days after the last medication.\n\nExclusion Criteria:\n\nSubjects who meet any of the following conditions will not be eligible to participate in this study:\n\n1. At baseline, the eyeball protrusion of the study eye decreased by ≥2 mm compared with the screening period;\n2. Subjects who have been previously diagnosed with DON, or who are determined by the investigator to have DON during screening (defined as: orbital MRI\u002FCT showing orbital apex crowding or optic nerve compression, and at least 2 of the following ophthalmological examination abnormalities that cannot be explained by other reasons: ① best corrected visual acuity \\[BCVA\\] \\\u003C 0.8 or BCVA decreased by ≥ 2 lines compared with before the onset; ② abnormal pupillary light reflex or relative pupillary afferent disorder; ③ color vision abnormalities; ④ optic disc edema and optic disc pallor on fundus examination; ⑤ visual field loss; ⑥ visual evoked potential with prolonged latency and\u002For decreased amplitude);\n3. Patients with corneal ulcers that are judged by the researchers to have no relief after treatment;\n4. Planned to receive orbital radiotherapy or surgical treatment for TED (including orbital decompression, strabismus correction, eyelid correction, etc.) at any time before baseline or during the study period;\n5. Poorly controlled thyroid function, defined as free triiodothyronine (FT3) or free thyroxine (FT4) deviating from the normal reference value range of the local research center laboratory by more than 50% during screening;\n6. Any other diseases, metabolic disorders, abnormal physical examination or clinical laboratory test results, and there is reason to suspect that there may be diseases or conditions that may lead to contraindications to the use of the trial drug, affect the interpretation of the study results, or put the subjects at high risk of treatment complications, including but not limited to: confirmed or clinically suspected inflammatory bowel disease, coagulation disorders, history of acute cardiovascular and cerebrovascular diseases or treatment history within 180 days before screening(including but not limited to: cerebrovascular accident, transient ischemic attack, acute myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention \\[except diagnostic angiography\\], severe arrhythmia, etc.), history of malignant tumors treated or untreated in the past 5 years (except for skin squamous cell carcinoma, basal cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or thyroid papillary carcinoma that have been successfully removed and have no evidence of metastasis), severe systemic infection, proptosis not caused by TED, etc.;\n7. During the screening period, any ear has: tinnitus or other history of hearing loss; or abnormal pure tone audiometry results (defined as average bone conduction hearing threshold ≥25 dB at 0.5, 1, 2, 4 kHz or bone conduction hearing threshold ≥40 dB at any frequency);\n8. At screening, aspartate aminotransferase (AST) or alanine aminotransferase (ALT)\\>3×ULN, or with active hepatitis B (defined as HBsAg positive with HBV-DNA load\\>1000 IU\u002FmL), or receiving anti-hepatitis B virus treatment;\n9. At screening, glomerular filtration rate (GFR) \\\u003C30 ml\u002Fmin\u002F1.73m2 (MDRD formula: GFR = 186 × serum creatinine (mg\u002Fdl) - 1.154 × (age) - 0.203 × (0.742 \\[if female\\]), serum creatinine unit conversion: 1 μmol\u002FL = 0.0113 mg\u002FdL);\n10. Poorly controlled diabetes at screening (defined as glycated hemoglobin ≥8.0% at screening);\n11. At screening, patients have poorly controlled hypertension, with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg; renal artery stenosis; or evidence of unstable blood pressure (including orthostatic hypotension, etc.);\n12. During screening, the 12-lead ECG shows a heart rate of \\\u003C50 beats\u002Fmin or \\>100 beats\u002Fmin, the ECG indicates active heart disease, or the investigator believes that the ECG abnormality during screening will interfere with the interpretation of the ECG results during subsequent follow-up, especially excluding QTcF\\>500 ms;\n13. HIV antibody or HCV antibody positive or active syphilis (defined as non-specific syphilis antibody positive or requiring anti-syphilis treatment after consultation with the infectious disease department);\n14. Oral or intravenous glucocorticoids within 30 days before screening;\n15. Use of glucocorticoid eye drops\u002Feye ointment, or non-steroidal immunosuppressant eye drops within 30 days before screening;\n16. Periorbital\u002Fperiorbital injection of glucocorticoids within 90 days before screening;\n17. Any other non-steroidal immunosuppressants taken orally or intravenously within 90 days before screening;\n18. Received interleukin-6 receptor (IL-6R) antibody treatment within 180 days before screening;\n19. Received CD20 antibody treatment within 1 year before screening;\n20. Received IBI311 or TEPEZZA treatment at any time before screening;\n21. Have received any other TED treatment drugs under development at any time before screening (including but not limited to biological agents targeting IGF-1R, FcRn, and TSHR);\n22. Use of any other monoclonal antibody treatment within 90 days before screening;\n23. Participated in other interventional clinical trials within 90 days before screening (for drugs, within 5 half-lives, whichever is longer; excluding vitamins and minerals), or attempted to participate in other clinical trials during the study;\n24. Female subjects who are pregnant or lactating;\n25. Those who are known to be allergic to the study drug ingredients, or have a history of allergies to other monoclonal antibodies; Those who are considered by the researchers to be unsuitable for participating in this clinical trial due to other reasons.",{"count":471,"type":22},111,[96],"A multicenter clinical study to evaluate the efficacy and safety of IBI311 in subjects with inactive thyroid eye disease. The study consists of two parts, with a maximum duration of approximately 64 weeks.",[120],"2025-11-13",{"date":455,"type":33},{"date":478,"type":33},"2025-09-10",{"date":212,"type":22},{"name":39,"class":40},{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":488,"targetDuration":4,"studyType":23,"phases":490,"briefSummary":491,"conditions":492,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":41},"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 RECISIT 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":489,"type":22},170,[52],"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.",[493],"Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer","2025-09-28",{"date":496,"type":33},"2025-09-30",{"date":498,"type":33},"2025-08-26",{"date":500,"type":22},"2030-04-30",{"name":39,"class":40},{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":511,"phases":4,"briefSummary":512,"conditions":513,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":41},"100608242","real-world-study-of-taletrectinib-in-advanced-ros1-nsclc-following-entrectinib-progression-100608242","NCT07199010","Real-world Study of Taletrectinib in Advanced ROS1+ NSCLC Following Entrectinib Progression","A Multicenter, Non-interventional, Observational Study of Taletrectinib in Advanced ROS1+ NSCLC Following Entrectinib Progression","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically or cytologically metastatic NSCLC (UICC\u002FAJCC TNM Staging System, 9th Edition, Stage Ⅳ).\n* At least one measurable target tumor lesion as accessed by RECIST v1.1 criteria.\n* Documented ROS1 gene fusion identified by an approved molecular testing method (FISH, RT-PCR, or NGS).\n* Progressed following entrectinib treatment, regardless of prior exposure to chemotherapy, antiangiogenic multikinase inhibitors, or immunotherapy.\n* Considered by the investigator to be candidates for Taletrectinib treatment ; OR Patients with ≤6 months of prior Taletrectinib exposure enrolled retrospectively. (Note: For retrospective patients deceased before enrollment, waiver of informed consent is required. Patients who initiated and discontinued treatment within 6 months prior to signing informed consent are eligible).\n* Signed Informed Consent.\n\nExclusion Criteria:\n\n* Patients with driver gene mutations\u002Falterations that have approved targeted therapies , including but not limited to EGFR, ALK, RET, etc.\n* Currently participating in other interventional clinical trials or having received investigational drug treatment within 4 weeks prior to enrollment .\n* Pregnancy or breastfeeding.\n* Patients with uncontrolled co-morbidities who are assessed by the investigator not to receive targeted therapy.\n* Other conditions that are assessed by the investigator to be unsuitable for enrollment in this study.",{"count":510,"type":22},50,"OBSERVATIONAL","This is a multicenter, non-interventional, observational real-world study to evaluate the efficacy and safety of Taletrectinib in ROS1-positive non-small cell lung cancer (NSCLC) following Entrectinib progression. Patients deemed eligible for Taletrectinib by their physicians were enrolled after providing informed consent. Taletrectinib will be administered according to clinical practice and data on treatment patterns, clinical outcomes, and safety will be collected during routine evaluations.",[514],"Non-small Lung Cancer","2025-09-22",{"date":496,"type":33},{"date":518,"type":22},"2025-10",{"date":520,"type":22},"2027-12",{"name":39,"class":40},{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":529,"targetDuration":4,"studyType":23,"phases":531,"briefSummary":532,"conditions":533,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":41},"100602536","phase-2-a-study-of-ibi363-combination-therapy-in-participants-with-advanced-solid-tumors-100602536","NCT07124793","A Study of IBI363 Combination Therapy in Participants With Advanced Solid Tumors","Phase II Study to Evaluate the Efficacy and Safety of IBI363 in Combination With IBI305 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\nSubjects must meet all of the following inclusion criteria to be enrolled in the study:\n\n1. Sign the written informed consent form and be able to comply with the visit arrangements and related procedures specified in the protocol.\n2. Aged \\>= 18 years and \\\u003C= 75 years, regardless of gender.\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.\n4. Expected survival time \\>= 3 months.\n5. Locally advanced or metastatic solid tumors confirmed by histology or cytology that are inoperable and cannot receive radical concurrent radiotherapy and chemotherapy:\n6. Cohort A (EGFR-mutated NSCLC):\n\n   * Histologically or cytologically confirmed unresectable locally advanced or metastatic non-small cell lung cancer;\n   * Documented EGFR mutation (ex19del or L858R) detected in tumor tissue or blood samples;\n   * Have progressed on or are intolerant to at least 1 prior line of approved EGFR TKI for metastatic or locally advanced NSCLC.T790M mutation requires 3rd generation TKI;\n   * Patients with metastatic or locally advanced NSCLC who have shown progression or intolerance after at least 1 line of platinum-based chemotherapy;\n   * Intolerance to or progression of the most recent line of anti-tumor therapy.\n7. Cohort B (PROC):\n\n   * Histologically or cytologically confirmed locally advanced unresectable or metastatic ovarian cancer, primary peritoneal cancer, or fallopian tube cancer;\n   * Subjects with a documented breast cancer gene (BRCA) mutation (germline and\u002For somatic) must have been previously treated with a poly(ADP-ribose) polymerase (PARP) inhibitor;\n   * For subjects with documented positive folate receptor-α (FRα) expression in tumor tissues, they should have previously received mirvetuximab soravtansine (MIRV) or ADC drugs with the same target, and have radiologically or pathologically confirmed PD;\n   * Patients who have previously received ≥ 1 line of platinum-based chemotherapy and experienced progressive disease;\n\n     * If you have only received 1 line of platinum-based chemotherapy, you must have received at least 4 cycles of platinum-based therapy, the best response is PR or CR, and disease progression occurs \\> 3 months and \\\u003C 6 months after the last platinum-based chemotherapy;\n     * If receiving 2 or more lines of platinum-based chemotherapy, must have had disease progression during or \\\u003C 6 months after the last line of platinum-based chemotherapy Note: Disease progression is confirmed by imaging or pathology.\n   * Must have received at least 1 line of prior systemic anti-cancer therapy:\n\n     * Adjuvant ± neoadjuvant therapy is considered as first-line systemic anti-tumor treatment;\n     * Maintenance therapy \\[e.g., bevacizumab and PARP inhibitors\\] as part of front-line anti-tumor treatment (the number of lines will not be counted separately);\n     * For a change in treatment regimen, if the changed therapeutic drug is the same type of drug as the previous first-line treatment (for example, platinum, taxane, anthracycline, PARP inhibitor, etc. before and after the change), and there is no imaging disease progression before the change in therapeutic drug, the changed therapeutic regimen will be considered as part of the number of lines of treatment as before and will not be counted separately;\n     * If the changed therapeutic drug is a different type of drug from the previous first-line treatment, or if radiographic disease progression occurs before the change of treatment, the number of lines needs to be calculated separately.\n8. Adequate bone marrow and organ function:\n\n   * Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL; eosinophils \\\u003C 1.5 × upper limit of normal (ULN); platelet count (PLT) ≥ 100 × 109\u002FL; hemoglobin ≥ 9.0 g\u002FdL; have not received treatment with erythropoietin (EPO), granulocyte-colony stimulating factor (G-CSF), or granulocyte-macrophage colony stimulating factor (GM-CSF) within 14 days prior to the first dose, and have not received blood transfusion (including red blood cell and platelet transfusion) within at least 14 days;\n   * Liver function: total bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN, without liver metastasis (if liver metastasis is present, ≤ 5 × ULN); albumin ≥ 3.0 g\u002FdL (without albumin infusion within 14 days before the first dose);\n   * Renal function: serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL\u002Fmin (using Cockcroft-Gault formula \\[Appendix 4\\]); and urine protein \\\u003C 2+ or total 24-h urine protein \\\u003C 1 g;\n   * Coagulation function: International normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (subjects receiving anticoagulant therapy with coagulation function within the above range are allowed to be enrolled);\n9. At least one measurable lesion according to RECIST v1.1.\n10. For female subjects of childbearing age, a negative urine or serum pregnancy test within 7 days prior to receiving the first study drug administration. If the urine pregnancy test result is positive, a blood pregnancy test is required to be clearly negative or not pregnant;\n\nExclusion Criteria:\n\n1. Cohort B (PROC) should not be enrolled if any of the following criteria is met based on histological or cytological findings:\n\n   1. Documented sarcoma, mucinous carcinoma, undifferentiated carcinoma, or a combination thereof;\n   2. Confirmed low-grade or borderline tumors, or contains the above components.\n2. Previously received IL-2\u002FIL-15 cytokine therapy. Except for the use of IL-2\u002FIL-15 as an adjuvant component of adoptive cell therapy or as an immunomodulatory therapy for immunocompromised subjects.\n3. Excluded medications and other treatments (subjects should not receive any of the following treatments):\n\n   * Have received small-molecule targeted therapy or oral chemotherapy within 2 weeks or 5 half-lives (whichever is longer) before the first dose of the study drug; have received intravenous infusion of chemotherapy drugs within 3 weeks before the first dose of the study drug; have received Chinese herbal medicines with anti-tumor indications within 2 weeks before the first dose of the study drug;\n   * Nitrosourea antineoplastic agents and mitomycin C within 6 weeks prior to the first dose of study drug;\n   * Use of any antibody-based anti-tumor therapy within 4 weeks prior to the first dose of the study drug;\n   * Participation in any medical device or other therapeutic interventional clinical trial within 2 weeks prior to the first dose of study drug;\n   * Palliative radiotherapy within 2 weeks prior to the first dose of the investigational product, or radical radiotherapy within 4 weeks prior to the first dose;\n   * Received adoptive cell therapy within 8 weeks prior to the first dose of study drug;\n   * Use of live vaccines against infectious disease prophylaxis within 4 weeks prior to the first dose of study drug.\n4. Active or untreated central nervous system metastasis (such as brain or leptomeningeal metastasis) confirmed by imaging assessment during screening or previous imaging assessment.\n\n   * Subjects with asymptomatic brain metastases (i.e., no neurologically relevant symptoms, no corticosteroid treatment is required, and the diameter of metastatic lesions is ≤ 1.5 cm) may participate in this study.\n   * Subjects whose symptoms of brain metastases are stable for ≥ 4 weeks after treatment and whose brain metastases do not increase in number or further increase after the end of treatment may participate in this study as long as they meet all of the following criteria:\n\n     * Measurable lesions outside the central nervous system;\n     * No metastases to meninges, midbrain, pons, medulla oblongata, or spinal cord; no multiple cerebellar metastases;\n     * No compression of the aqueduct of the midbrain, no compression of the third or fourth ventricle, and no spinal cord compression;\n     * Hormone therapy is discontinued 14 days prior to the first dose of the study drug.\n\n   Note: Central nervous system lesions are not considered target lesions.\n5. The tumor invades surrounding important tissue structures (such as mediastinal great vessels, superior vena cava, inferior vena cava, pericardium, heart, trachea, esophagus, etc.) or has the risk of gastrointestinal\u002Frespiratory fistula.\n6. The subject has a history of significant toxicity related to immune checkpoint inhibitor administration and requires permanent discontinuation of the treatment.\n7. Subjects with adverse reactions related to any previous anti-tumor treatment that have not recovered to Grade 0-1; except for persistent Grade 2 alopecia, peripheral neuropathy, hypomagnesemia, toxicities that are expected to be unrecoverable but stably controlled by the drug, and other conditions that the investigator considers to have no safety risk.\n8. Have not recovered sufficiently from previous surgery, or have undergone any major surgery within 4 weeks prior to the first dose of the study drug.\n9. Cardiovascular and cerebrovascular diseases with significant clinical significance, including:\n\n   * Ventricular arrhythmia or other uncontrolled arrhythmias requiring medical intervention, such as antiarrhythmic drug therapy, etc.;\n   * Severe conduction disorders (e.g., 3rd degree atrioventricular block);\n   * HR-corrected QT interval (QTc interval, calculated using the Fridericia method \\[Appendix 5\\]) ≥ 480 ms;\n   * Uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg) despite of standard treatment;\n   * History of myocarditis;\n   * Congestive heart failure currently requiring treatment;\n   * Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n   * Class III or IV cardiovascular disease according to New York Heart Association (NYHA) functional classification;\n   * History of acute coronary syndrome (including myocardial infarction and unstable angina), coronary angioplasty or stenting within 6 months prior to the first dose of the study drug;\n   * History of any arterial thromboembolic events within 6 months prior to the first dose of study treatment, including myocardial infarction, unstable angina, cerebrovascular accident, etc.\n   * History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolic event within 3 months prior to the first dose of study drug (thrombus or catheter-derived thrombus caused by an implanted venous port or superficial venous thrombosis is not considered a serious thromboembolism).\n   * Known active seizures.\n10. Subjects with interstitial pneumonia requiring steroid hormones or other treatments, or a history of other clinically significant lung diseases (such as pulmonary fibrosis, pneumoconiosis, interstitial lung disease, non-infectious pneumonia), or uncontrolled lung diseases (such as pulmonary fibrosis, severe radiation pneumonitis and acute lung injury) or suspected of having such diseases through imaging examinations during the screening period.\n11. Allergic constitution, asthma, history of atopic dermatitis.\n12. Pleural effusion, abdominal effusion or pericardial effusion requiring drainage or with obvious symptoms.\n13. Active autoimmune diseases requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments.\n14. Have used immunosuppressive drugs within 14 days before the first study treatment, excluding intranasal and inhaled corticosteroids, or use systemic corticosteroids with a dose of less than 10 mg\u002Fday prednisone (or other corticosteroids with an equivalent dose to 10 mg\u002Fday prednisone), or use corticosteroids to prevent allergy to contrast agents.\n15. Known allogeneic organ transplantation;",{"count":530,"type":22},60,[52],"CIBI363A203, a Phase 2 study to evaluate the safety, tolerability and preliminary efficacy of IBI363 combined with IBI305 (a bevacizumab biosimilar) in participants with advanced malignancies conducted in China. Primary endpoint is objective response rate (ORR) per RECIST v1.1. Secondary endpoints include DoR, DCR, TTR, PFS, per RECIST v1.1, and OS; the incidence and severity of AEs, irAEs, SAEs, AESIs and their relationship to the investigational drug, and changes in vital signs, physical examination, and laboratory values before and after study treatment; PK, and immunogenicity of IBI363. The cohorts include: IBI363 and IBI305 combination therapy in participants with advanced EGFRmut NSCLC progressed after EGFR TKI and Platinum-based chemotherapy, and advanced platinum-resistant ovarian cancer (PROC). The anticipated enrollment for this study is approximately 60 participants with each cohort 30 participants, and actual enrollment may change with future amendments as cohorts are opened and closed based on evolving data.",[534],"EGFR Mutant NSCLC and Platinum Resistant Ovarian Cancer","2025-08-14",{"date":537,"type":33},"2025-08-15",{"date":539,"type":22},"2025-08-31",{"date":541,"type":22},"2028-09-30",{"name":39,"class":40},""]