[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":177},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,41,68,91,112,133,155],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100643530","phase-2-neoadjuvant-and-adjuvant-therapy-studies-of-sintilimab-combined-with-chemotherapy-with-or-without-ipilimumab-n01-in-resectable-gastricgastroesophageal-junction-adenocarcinoma-100643530",false,"NCT07643623","Neoadjuvant and Adjuvant Therapy Studies of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Resectable Gastric\u002FGastroesophageal Junction Adenocarcinoma","A Randomized, Double-Blind, Phase II\u002FIII Clinical Study of the Efficacy and Safety of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric\u002FGastroesophageal Junction Adenocarcinoma","Inclusion Criteria\n\n1. Signed written Informed Consent Form (ICF) and ability to comply with protocol-specified visits and related procedures.\n2. Age ≥ 18 years.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n4. Expected survival ≥ 6 months.\n5. Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ). For GEJ cancer, only Siewert type III and Siewert type II participants not requiring combined thoracotomy are eligible.\n6. Clinical stage T3-4Nany or TanyN+M0 (stage II-IVa) gastric\u002FGEJ adenocarcinoma confirmed by endoscopic ultrasound or contrast-enhanced CT\u002FMRI within 4 weeks before the first dose, per the American Joint Committee on Cancer (AJCC) 8th edition gastric cancer TNM staging system.\n7. Within 4 weeks before the first dose, evaluated by a responsible surgeon based on medical history and confirmed to meet study requirements for radical R0 resection.\n\nExclusion Criteria\n\n1. Histologically or cytologically confirmed other pathologic types (e.g., squamous cell carcinoma, sarcoma, undifferentiated carcinoma) or combined gastrointestinal stromal tumor (GIST) before randomization.\n2. Suspicious metastatic lesions or locally advanced unresectable disease, regardless of stage.\n3. History of gastrointestinal perforation or fistula within 6 months before randomization. May be enrolled if perforation\u002Ffistula has been surgically treated (repaired\u002Fresected) and disease recovery\u002Fremission is confirmed by the investigator.\n4. Active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.\n5. Inability to swallow, malabsorption syndrome, or uncontrolled nausea\u002Fvomiting\u002Fdiarrhea, or other severe gastrointestinal diseases affecting drug intake\u002Fabsorption.\n6. Any life-threatening bleeding event within 3 months before randomization, or grade 3\u002F4 gastrointestinal\u002Fvariceal bleeding requiring endoscopic\u002Fsurgical intervention.\n7. Active uncontrolled bleeding or known bleeding diathesis.","ALL","18 Years",{"count":19,"type":20},720,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","This is a Randomized, Double-Blind, Phase II\u002FIII Clinical Study of the Efficacy and Safety of Sintilimab Combined with Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric\u002FGastroesophageal Junction Adenocarcinoma.",[27],"Resectable Gastric\u002FGastroesophageal Junction Adenocarcinoma","NOT_YET_RECRUITING","2026-06-09",{"date":31,"type":32},"2026-06-11","ACTUAL",{"date":34,"type":20},"2026-06-15",{"date":36,"type":20},"2031-12-31",{"name":38,"class":39},"Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":40},"100637261","phase-1-study-of-ibi3028-in-participants-with-locally-advanced-unresectable-or-metastatic-solid-tumors-100637261","NCT07589205","Study of IBI3028 in Participants With Locally Advanced, Unresectable, or Metastatic Solid Tumors","A Phase 1, Multi-Center, Open-Label Study Evaluating IBI3028 Treatment in Participants With Locally Advanced, Unresectable, or Metastatic Solid Tumors","Inclusion Criteria\n\n1. Be able to understand and sign written informed consent to participate in this study, including all assessments and procedures specified in this protocol;\n2. Male or female participants aged 18 years or older;\n3. Have histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors;\n4. Have at least one evaluable lesion (dose escalation) or measurable lesion (dose expansion) as per RECIST v1.1 within 28 days prior to the first dose of IBI3028;\n5. ECOG PS（Eastern Cooperative Oncology Group Performance Status）score of 0-1;\n6. Anticipated life expectancy of ≥ 12 weeks;\n7. Adequate bone marrow and organ function as evidenced by :\n\n   1. Hematological function: ANC(Absolute neutrophil count) ≥ 1.5 × 10 9 \u002FL; platelet count (PLT) ≥ 90 × 10 9 \u002FL; hemoglobin ≥ 9.0 g\u002FdL, and without receiving granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage colony stimulating factor (GM-CSF), thrombopoietin (TPO), interleukin-11, or other leukocyte\u002Fplatelet stimulating growth factors (including red blood cell and platelet transfusions) within at least 7 days before the first dose of the study drug;\n   2. Hepatic function: total bilirubin ≤ 1.5 × ULN (Upper Limit of Normal) (≤ 3 × ULN for participants with Gilbert's syndrome); AST(Aspartate Aminotransferase) and ALT (Alanine Aminotransferase)≤ 2.5 × ULN in the absence of liver metastases (≤ 5 × ULN if liver metastases are present); albumin ≥ 2.8 g\u002FdL;\n   3. Renal function: creatinine clearance ≥ 30 mL\u002Fmin (using Cockcroft-Gault formula); urine protein \\\u003C 2+ or 24-h total urine protein \\\u003C 1 g;\n   4. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%, no clinically significant pericardial effusion as determined by ECHO or MUGA(Multigated Acquisition), and no clinically significant ECG result;\n   5. Coagulation function: International normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (participants receiving anticoagulant therapy with coagulation function within the range above are allowed);\n   6. Pulmonary function: With at least the lowest level of pulmonary reserve, defined as Grade ≤ 1 dyspnea and blood oxygen saturation ≥ 95% in non-oxygen breathing state;\n8. Participants (both male and female participants) who will be not of childbearing potential or who agree to use at least 1 highly effective method of contraception during the study (from start of screening or within 2 weeks prior to first dose, whichever occurs first, and continue until 7 months for females and 4 months for males after the last dose of study drug).\n\nExclusion Criteria\n\n1. Participation in any other interventional clinical study other than an observational (non-interventional) study or during the follow-up period of an interventional study;\n2. Prior anti-tumor therapy:\n\n   Participants who have received cytotoxic therapy within 3 weeks or 5 half-lives (whichever is shorter) prior to the first administration of study intervention ; Participants who have received PD-1\u002FPD-L1 therapy within 4 weeks prior to the first administration of study drug; Participants who have received treatment with small molecule targeted therapy within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of the study drug; Palliative radiation therapy within 2 weeks or radical radiation therapy within 4 weeks prior to the first dose of study drug; Participants who had received adoptive cell therapy within 8 weeks prior to the first administration of study intervention.\n3. Have received live vaccines within 4 weeks or tumor vaccines within 3 months prior to the first administration of the study drug, or plan to receive any live vaccines during the study;\n4. Use of strong cytochrome P450 3A4 (CYP3A4) enzyme inhibitors within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study drug;\n5. Adverse reactions caused by previous anti-tumor treatments that have not resolved to Grade 0 or 1 or baseline level according to NCI CTCAE v5.0 before the first dose of the study drug (except for alopecia, fatigue, pigmentation, and other conditions with no safety implications per the Investigator's clinical judgement);\n6. Known allergies, hypersensitivity, or intolerance to IBI3028 or its excipients (refer to the Investigator's Brochure);\n7. Have undergone major surgery (craniotomy, thoracotomy, or laparotomy, and other surgeries according to Investigators' opinion, excluding needle biopsy) within 4 weeks prior to the first dose of the investigational product, or are expected to undergo major surgery during the study, or have severe unhealed wounds, ulcers, etc.;\n8. Known symptomatic central nervous system (CNS) metastases. Participants with asymptomatic CNS metastases (ie, no neurologic syndrome and metastases ≤1.5 cm in diameter) or stable disease after treatment as judged by the investigator may be considered if: they have no metastases in the midbrain, pons, cerebellum, meninges, medulla oblongata, or spinal cord; stable status for at least 4 weeks prior to the first dose of study drug (≤1.5 mg\u002Fday dexamethasone or equivalent and baseline anticonvulsants are allowed), and have no new or enlarging CNS metastases as clearly demonstrated by clinical evidence; Note : CNS lesions are not considered target lesions.\n9. Uncontrolled disease or condition, including:\n\n   1. Uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals prior to the first dose of the study drug;\n   2. With known human immunodeficiency virus (HIV) infection, or HIV positive (HIV 1\u002F2 Ab positive), for participants outside mainland China, participants with positive HIV antibody test at screening are eligible to participate in the study under the premise of undetectable viral load, or well-controlled under antiretroviral therapy (defined as CD4+ T cell count ≥ 350 cells\u002FμL and no history of AIDS-defining opportunistic infection within 12 months before the first dose);\n   3. Acute or chronic active hepatitis B (HBsAg positive and\u002For HBcAb positive, and HBV DNA titer ≥ 10 4 copies\u002FmL or ≥ 2000 IU\u002FmL) or hepatitis C (HCV Ab positive, and HCV RNA \\> 10 3 copies\u002FmL or above the lower limit of detection);\n   4. Active tuberculosis infection, or still receiving anti-tuberculosis treatment, or receiving anti-tuberculosis treatment within 1 year before the first dose of the study drug;\n   5. Uncontrolled myocarditis or symptomatic congestive heart failure Class II-IV (New York Heart Association ,NYHA), symptomatic or uncontrolled arrhythmia, QTc interval \\> 480 ms, or personal or family history of congenital long\u002Fshort QT syndrome;\n   6. Uncontrolled hypertension with SBP ≥ 160 mmHg or DBP ≥ 100 mmHg measured on 2 follow-up visits despite adequate standard treatment;\n   7. Current gastrointestinal tract (muscle-derived tube from the oral cavity to the anus, including oral cavity, pharynx, esophagus, stomach, duodenum, jejunum, ileum, cecum, appendix, colon, rectum, and anus) or endotracheal stent implantation;\n   8. Significant malnutrition, such as malnutrition requiring parenteral nutrition;\n   9. Spinal cord compression that has not been radically cured by surgery and\u002For radiotherapy;\n   10. Ascites, pleural effusion, or pericardial effusion that is symptomatic and requires intervention prior to the first dose of study intervention (participants who do not require treatment or who recover steadily without intervention are eligible).\n10. With a history of pneumonia requiring corticosteroid treatment, or a history of clinically significant lung diseases (such as interstitial lung disease, non-infectious pneumonitis, or uncontrolled lung diseases such as pulmonary fibrosis, severe radiation pneumonitis, and acute lung injury), or suspected of having these diseases by imaging during the screening period;\n11. Any history of arterial thromboembolic events within 6 months prior to the first dose of the study drug, including myocardial infarction, unstable angina, cerebrovascular stroke, or transient ischemic attack;\n12. Esophageal or gastric varices requiring immediate intervention (e.g., ligature or sclerotherapy) or at high risk of bleeding according to the opinion of the investigator or a gastroenterologist or hepatologist. Participants with evidence of portal hypertension (including imaging findings of hypersplenism) or a history of esophageal and gastric variceal bleeding must undergo endoscopic evaluation within 3 months prior to the first dose of the study drug;\n13. Any history of life-threatening hemorrhage or hemorrhage requiring blood transfusion, endoscopy, or surgery within 3 months prior to the first dose of the investigational product ;\n14. Unhealed gastrointestinal obstruction, perforation, or fistula. At risk of gastrointestinal obstruction or perforation (including but not limited to: acute diverticulitis, abdominal abscess, etc.), history of extensive bowel resection (segmental colectomy or extensive bowel resection accompanied with chronic diarrhea), active inflammatory bowel disease, or Grade ≥ 2 chronic diarrhea;\n15. History of immunodeficiency diseases, including congenital or acquired immunodeficiency diseases;\n16. History of allogeneic organ transplantation or allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation within 3 months prior to the first dose of the investigational drug, except for corneal transplantation;\n17. History of other malignancy within 2 years before the first dose of study drug(s), with the following exceptions:\n\n    1. Malignancy (other than in situ) treated with curative therapy with no known active disease present for ≥ 2 years prior to the first dose of study drug and at low risk of recurrence according to the physician's opinion;\n    2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of residual or recurrent disease;\n    3. Adequately treated carcinoma in situ without evidence of residual or recurrent disease;\n    4. Prostate intraepithelial neoplasia without evidence of prostate cancer;\n    5. Adequately treated urothelial papillary non-invasive carcinoma.\n18. Presence of any indwelling tubes or drains (such as percutaneous nephrostomy tubes, indwelling Foley catheters, biliary drainage tubes, or peritoneal\u002Fpericardial catheters); Note: Thoracic catheters or dedicated central venous access catheters such as Port-A-Cath or Hickman catheters are allowed.\n19. Other acute or chronic diseases or laboratory abnormalities, which may increase the risk of participating in the study or receiving the investigational product, interfere with the interpretation of study results, and make the participant unsuitable for participating in the study based on the investigator's judgment;\n20. Neurological, mental, or social conditions that affect the compliance with trial requirements, significantly increase the risk of AEs, or affect the participants' signing of written informed consent (IC);\n21. Females who are pregnant, have a positive pregnancy test result, or are breastfeeding;\n22. Not fit to participate in this study at the discretion of the Investigator.",{"count":49,"type":20},493,[51],"PHASE1","This is a phase 1 multi-center, open-label study evaluating IBI3028 Treatment in participants with locally advanced, unresectable, or metastatic solid tumors",[54,55,56,57,58],"Solid Tumor","Colorectal Cancer","Non-small Cell Lung Cancer","Pancreatic Ductal Adenocarcinoma","Head and Neck Squamous Cell Carcinoma","RECRUITING","2026-05-11",{"date":62,"type":32},"2026-05-15",{"date":64,"type":32},"2026-03-31",{"date":66,"type":20},"2028-06-30",{"name":38,"class":39},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100630637","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-ibi310-and-sintilimab-combination-therapy-in-patients-with-hepatocellular-carcinoma-as-first-line-treatment-100630637","NCT07490262","A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular Carcinoma as First-line Treatment.","A Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy as First-line Treatment in Previously Untreated Patients With Unresectable or Metastatic Hepatocellular Carcinoma","Inclusion criteria:\n\n1. Histologically or cytologically confirmed hepatocellular carcinoma (HCC).\n2. Age ≥18 years and ≤75 years.\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.\n4. Barcelona Clinic Liver Cancer (BCLC) staging of Stage C, or Stage B that is unsuitable for curative-intent surgery and\u002For locoregional therapy.\n5. No prior systemic antineoplastic therapy for HCC before first dose.\n6. At screening, per RECIST 1.1, there must be at least one measurable lesion that has not undergone local therapy, or a measurable lesion that has clearly progressed following local therapy (per RECIST 1.1).\n7. Child-Pugh score ≤7.\n8. Adequate organ and bone marrow function.\n9. Expected survival ≥12 weeks at the time of treatment initiation.\n10. Female participants of childbearing potential, or male participants whose sexual partners are of childbearing potential, must use effective contraception throughout the treatment period and for 15 months after the last dose of oxaliplatin (for females) \u002F 12 months after the last dose of oxaliplatin (for males), or for 6 months after the last dose of any other investigational drug-whichever period ends later.\n11. Signed written informed consent form, and ability to comply with scheduled visits and all protocol-specified procedures.\n\nExclusion criteria:\n\n1. Histologically or cytologically confirmed diagnosis of fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, cholangiocarcinoma, or other mixed hepatic malignancies containing these components.\n2. History of hepatic encephalopathy or prior liver transplantation.\n3. Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring therapeutic drainage; participants with only minimal (radiologically detected), asymptomatic effusions may be enrolled.\n4. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection:\n5. Known central nervous system (CNS) metastases or symptomatic spinal cord compression.\n6. Esophageal or gastric variceal bleeding due to portal hypertension within the past 6 months; Grade 3 (G3) esophageal\u002Fgastric varices documented by endoscopy within 3 months prior to first dose; or evidence of portal hypertension.\n7. Life-threatening hemorrhagic event within the past 3 months, including but not limited to events requiring blood transfusion, surgical or local intervention, or ongoing pharmacologic hemostatic therapy.\n8. Metastatic lesions invading major vessels, airways, or the mediastinum with clinically significant bleeding risk.\n9. Arterial or venous thromboembolic event within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident (stroke), transient ischemic attack (TIA), pulmonary embolism, deep vein thrombosis, or other severe thromboembolic conditions.\n10. Portal vein tumor thrombus (PVTT) involving both the main portal vein and left\u002Fright branch; PVTT extending into the superior mesenteric vein; or PVTT involving the inferior vena cava.\n11. Use of aspirin (\\>325 mg\u002Fday) or other known platelet-function-inhibiting agents (e.g., dipyridamole or clopidogrel) for therapeutic purposes within 10 days prior to randomization. Prophylactic use of anticoagulants is permitted.\n12. Uncontrolled hypertension: systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\>100 mmHg despite optimal medical management; history of hypertensive crisis or hypertensive encephalopathy.\n13. Persistent treatment-related toxicities from prior anticancer therapy not resolved to Grade 0 or Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 at the time of randomization.\n14. Symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] Class II-IV); symptomatic or inadequately controlled arrhythmias; history of congenital long QT syndrome; or baseline corrected QT interval (QTcF, calculated using Fridericia's formula) \\>500 ms.\n15. Severe bleeding diathesis or coagulopathy; or current thrombolytic therapy.\n16. History of gastrointestinal perforation and\u002For fistula within the past 6 months; unresolved intestinal obstruction (including incomplete obstruction requiring parenteral nutrition); extensive bowel resection (e.g., partial colectomy or extensive small bowel resection leading to chronic diarrhea); Crohn's disease; ulcerative colitis; or chronic diarrhea of prolonged duration.\n17. Prior radiotherapy within 3 weeks before randomization.\n18. Clinically significant pre-existing pulmonary disease.\n19. Active tuberculosis (TB), currently receiving anti-TB therapy, or having completed anti-TB therapy within the past year.\n20. Known human immunodeficiency virus (HIV) infection (positive HIV-1\u002F2 antibody test).\n21. Active or inadequately controlled severe infection.\n22. Known or suspected active autoimmune disease, or history of active autoimmune disease within the past 2 years.\n23. Systemic immunosuppressive therapy within 2 weeks prior to randomization.\n24. Receipt of live attenuated vaccines within 4 weeks prior to randomization, or planned administration during the study.\n25. Major surgery (e.g., craniotomy, thoracotomy, laparotomy) or presence of unhealed wounds, ulcers, or fractures within 4 weeks prior to randomization.\n26. Local therapy for HCC within 4 weeks prior to first dose.\n27. Use of Traditional Chinese Medicine (TCM) with antitumor indications, or immunomodulatory agents (e.g., thymosin, interferons, interleukins), within 2 weeks prior to first dose.\n28. Uncontrolled or uncorrectable metabolic disorders, non-malignant organ dysfunction, systemic illness, or cancer-related paraneoplastic syndromes posing substantial medical risk or introducing uncertainty in survival assessment - as determined by the investigator; or any other condition deemed unsuitable for enrollment by the investigator.\n29. Diagnosis of another primary malignancy within 5 years prior to randomization.\n30. Prior treatment with any anti-PD-1, anti-PD-L1\u002FL2, anti-CTLA-4 antibodies, or other immune checkpoint inhibitors.\n31. Known hypersensitivity to any active ingredient or excipient of the investigational product; or history of severe allergic reaction (e.g., anaphylaxis) to other monoclonal antibodies.\n32. Receipt of treatment in another interventional clinical trial within 4 weeks prior to randomization.\n33. Female participants who are pregnant or breastfeeding.\n34. Any other acute or chronic medical condition, psychiatric disorder, or clinically significant laboratory abnormality that, in the Investigator's judgment: increases the risks associated with participation in the study or administration of the investigational product; or may interfere with the interpretation of study results - rendering the participant unsuitable for enrollment.","75 Years",{"count":77,"type":20},680,[23,24],"This study is a randomized, controlled, open-label, multicenter, seamless Phase II\u002FIII trial designed to evaluate the efficacy and safety of the combination regimen of IBI310 and sintilimab in participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who are: (1) treatment-naive to systemic therapy; and (2) either unsuitable for curative-intent surgical resection or local therapy, or have experienced disease progression following prior surgical resection or local therapy.",[81],"Hepatocellular Carcinoma (HCC)","2026-04-13",{"date":84,"type":32},"2026-04-16",{"date":86,"type":32},"2026-03-27",{"date":88,"type":20},"2030-12-31",{"name":38,"class":39},2,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":75,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":40},"100615661","phase-2-a-study-of-picankibart-in-patients-with-active-psoriatic-arthritis-100615661","NCT07295509","A Study of Picankibart in Patients With Active Psoriatic Arthritis","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II\u002FIII Clinical Study to Evaluate the Efficacy and Safety of Picankibart in Patients With Active Psoriatic Arthritis","Inclusion Criteria:\n\n1. Age 18-75 years\n2. Diagnosed with PsA for ≥3 months, and meeting Classification Criteria for Psoriatic Arthritis (CASPAR) at screening\n3. Having active PsA: ≥3 tender joints and ≥3 swollen joints at screening and baseline\n4. Having active plaque psoriasis (≥1 lesion ≥2cm) or nail psoriasis, or a documented history of plaque psoriasis\n5. Inadequate response or intolerance to prior NSAIDs or non-biologic DMARDs\n6. Stable doses of protocol permitted background therapy (if any)\n\nExclusion Criteria:\n\n1. Other inflammatory conditions that may affect the evaluation of the study drug\n2. Prior treatment with \\>2 biologic agents\n3. Recent use of prohibited medications (specific washout periods apply)\n4. Non-plaque psoriasis forms or drug-induced psoriasis\n5. Severe, progressive, or uncontrolled renal, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, hematological, rheumatic (excluding PsA), psychiatric, or genitourinary conditions\n6. Significant laboratory abnormalities\n7. Pregnancy or breastfeeding",{"count":99,"type":20},222,[23,24],"This is a multicenter, randomized, double-blind, placebo-controlled Phase II\u002FIII clinical trial evaluating the efficacy and safety of picankibart (IBI112) in patients with active psoriatic arthritis (PsA). The study consists of two stages: Phase II dose-finding (n=90) and Phase III confirmatory (n=132). Participants will receive subcutaneous (SC) injections of either picankibart (200mg) or placebo with different dosing schedules, with placebo crossover to active treatment at Week 26. The Phase II portion will identify optimal dosing for Phase III, which will confirm efficacy. The study will evaluate improvements in joint symptoms, physical function, quality of life, and skin manifestations. Primary endpoint is percentage of participants who achieved an American College of Rheumatology (ACR) 20 Response at Week 24.",[103],"Psoriatic Arthritis","2026-03-18",{"date":106,"type":32},"2026-03-20",{"date":108,"type":32},"2025-12-18",{"date":110,"type":20},"2029-12-31",{"name":38,"class":39},{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":21,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":40},"100621978","phase-3-ibi354-with-or-without-pertuzumab-versus-taxane-trastuzumab-and-pertuzumab-in-her2-positive-metastatic-breast-cancer-100621978","NCT07377643","IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer","A Randomized, Multicenter, Open-label Phase 3 Study to Compare IBI354 With or Without Pertuzumab vs. Taxane in Combination With Trastuzumab and Pertuzumab as First-line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Breast Cancer","Participants are eligible to be included in the study only if they meet all of the following criteria:\n\n1. Have signed the informed consent form (ICF) and are able to comply with the follow-up visits and related procedures required in the protocol.\n2. Male or female participants: ≥18 years of age\n3. Pathologically confirmed breast cancer:\n\n   1. Unresectable, locally advanced or metastatic breast cancer, i.e. participants who cannot be treated with curative intent and confirmed HER2-positive (HER2 IHC 3+ or HER2 ISH+) on specimens taken after confirmed locally advanced or metastatic disease by central testing.\n   2. Documented history of hormone receptor (HR)-positive (defined as estrogen receptor \\[ER\\] and\u002For progesterone receptor \\[PgR\\] positive \\[ER or PgR ≥1%\\]) or HR-negative after local testing in the metastatic setting according to ASCO\u002FCAP guidelines. If a participant has more than one ER\u002FPgR result after metastatic disease, the most recent result will be used.\n4. No prior chemotherapy or HER2-targeted therapy for unresectable, locally advanced or metastatic breast cancer (first-line endocrine therapy is allowed for patients with metastatic breast cancer). Participants who have received chemotherapy or HER2-directed therapy in the neoadjuvant or adjuvant therapies and have a DFI of \\>6 months from completion of systemic chemotherapy or HER2-targeted therapy to advanced or metastatic diagnosis are eligible.\n5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.\n6. Evidence of radiographic or objective disease progression on or after the last systemic therapy prior to starting study treatment.\n7. Have a life expectancy of ≥12 weeks at screening.\n8. At least 1 measurable lesion as defined per RECIST v1.1 that has not been previously irradiated. Must be ≥ 10 mm in long axis (except for lymph nodes, which must be ≥ 15 mm in short axis) when accurately measured at baseline by CT or MRI (preferably with intravenous contrast) and the lesion is suitable for repeated accurate measurement.\n9. Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days prior to randomization.\n10. Adequate organ and bone marrow function. Laboratory test values within 7 days prior to the first dose of the investigational product meet the following requirements in (if the laboratory tests during the screening period do not meet the following requirements, only one retest is allowed during the screening period):\n\n    1. Hemoglobin (HGB) ≥ 90 g\u002FL (transfusion of red blood cells or erythropoietin are not allowed within 1 week prior to the screening assessment, and participants requiring ongoing transfusion or growth factor support to maintain hemoglobin ≥ 90 g\u002FL are not eligible).\n    2. Absolute neutrophil count (ANC) ≥ 1.5 × 109 \u002FL or within the normal range (G-CSF is not allowed within 1 week prior to the screening assessment).\n    3. Platelet (PLT) ≥ 90 × 109 \u002FL (transfusion with platelets or thrombopoietin is not allowed within 1 week prior to screening assessment, participants requiring thrombopoietic growth factors to maintain adequate platelet count are not eligible).\n    4. Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) in the absence of liver metastasis; TBIL \\\u003C 3 × ULN in the presence of Gilbert syndrome (unconjugated hyperbilirubinemia) or liver metastasis.\n    5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN (\\\u003C5×ULN for participants with liver metastases).\n    6. Serum albumin ≥ 25 g\u002FL.\n    7. Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL\u002Fmin ( calculated using the Cockcroft-Gault formula ); if urinalysis indicates that the urine protein is \\\u003C 2+, participants with urine protein ≥ 2+ from urinalysis at baseline should undergo a 24-hour urine collection and have a 24-hour urine protein quantitation \\\u003C 1 g (if both methods are used, a 24-hour urine protein quantitation will be used to determine participant eligibility). Cockcroft\u002FGault formula:\n\n       Female: CrCl = (140 - Age) × Weight (kg) × 0.85 72 × serum creatinine (mg\u002FdL) Male: CrCl = (140 - years) × weight (kg) × 1.00 72 × serum creatinine (mg\u002FdL)\n    8. International normalized ratio (INR) ≤ 1.5 × ULN, and prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n11. Participants with evidence of postmenopausal status or negative serum pregnancy test (Sexually active, WOCBP with a non-sterilized male partner) must have a negative serum pregnancy test at the screening visit. WOCBP are women who are not surgically sterile (i.e., have undergone bilateral salpingectomy, bilateral oophorectomy, or total hysterectomy) or are not postmenopausal.\n12. Female participants of childbearing potential or male participants with partners of childbearing potential must take effective contraceptive measures during the entire course of the trial and 6 months after the treatment\n\nParticipants should not be included in the study if they meet any of the following criteria:\n\n1. Prior treatment with antibody-drug conjugates containing camptothecin or its derivatives (topoisomerase I inhibitors).\n2. Uncontrolled or significant cardiovascular and cerebrovascular diseases, including any of the following:\n\n   1. History of myocardial infarction or symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class II to IV) or uncontrolled myocarditis within 6 months before randomization. Participants with troponin levels above the ULN at screening (as specified by the manufacturer) and without any myocardial infarction-related symptoms should have a cardiology consultation before randomization to rule out myocardial infarction.\n   2. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg) despite of standard treatment.\n   3. History of any arterial thromboembolic events within 6 months prior to randomization, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.\n   4. History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolic events within 3 months prior to randomization (thrombosis or catheter-derived thrombosis of caused by implanted venous ports, or superficial vein thrombosis, intermuscular vein thrombosis are not considered serious thromboembolisms).\n   5. History of arrhythmia (polymorphic premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, ventricular fibrillation, torsades de pointes) that is symptomatic or requires treatment (CTCAE 5.0 Grade 3), atrial fibrillation that is symptomatic or uncontrolled despite treatment, or asymptomatic sustained ventricular tachycardia. Participants whose atrial fibrillation is controlled by medication or whose arrhythmia is controlled by a pacemaker will be allowed to be enrolled in the study.\n   6. Fridericia-corrected QT interval (QTcF) \\>480 msec. If QTcF is \\> 480 ms in 1 ECG during the screening period, 3 consecutive ECGs should be performed and the mean QTcF should be calculated. If QTcF is still \\> 480 ms, the participant will not be enrolled.\n   7. History of QT prolongation associated with other drugs that require discontinuation, or any current concomitant medication known to prolong QT interval leading to Torsade de Pointes.\n   8. Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death in first-degree relatives under 40 years old.\n3. Non-infectious pneumonitis that requires corticosteroid treatment, or other clinically significant lung diseases such as a history of interstitial lung disease (ILD)\u002Fnon-infectious pneumonitis, current ILD\u002Fnon-infectious pneumonitis, or uncontrolled lung diseases (e.g., pulmonary fibrosis, severe radiation pneumonitis, and acute lung injury) or suspected ILD\u002Fnon-infectious pneumonitis cannot be ruled out by imaging at screening.\n4. Have a lung-specific intercurrent clinically significant illness including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary embolism within 3 months prior to study randomization, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disorder, significant pleural effusion, post-COVID-19 pulmonary fibrosis, etc.), and any autoimmune, connective tissue, or inflammatory disorder with pulmonary involvement (or suspected at screening for pulmonary involvement) (e.g., rheumatoid arthritis, Sjogren's syndrome\u002FSjogren's syndrome, sarcoidosis etc.), and\u002For prior pneumonectomy.\n5. Prior to the first dose of study drug:\n\n   1. Antibody-based anticancer therapy within 4 weeks, except for receptor activator of nuclear factor-κb ligand (RANKL) inhibitors (eg, denosumab for the treatment of complications resulting from bone metastases).\n   2. Hormonal therapy or immunotherapy (based on non-antibody therapy) within 3 weeks.\n   3. Fixed-field palliative radiotherapy within 2 weeks, or wide-field palliative radiotherapy within 4 weeks or palliative radiotherapy cumulatively exceeding 30% of bone marrow.\n   4. Received oral chemotherapy drugs, small molecule targeted drugs, and Chinese herbal medicines indicated for anti-tumor treatment within 2 weeks or 5 half-lives (whichever is longer).\n   5. Had major surgery (craniotomy, thoracotomy, or laparotomy, and other types of surgery considered \"major\" by the investigator, excluding needle biopsy and vascular access) or major traumatic injury within 4 weeks, or expected major surgery during the study, or with severe unhealed wounds, trauma, or ulcers.\n   6. Treatment with strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks or 5 half-lives (whichever is longer).\n   7. Live vaccines (mRNA and non-replicating adenovirus vaccines are not considered live) within 4 weeks.\n6. Participants who had used immunosuppressive medications within 14 days prior to the first dose of study drug, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at doses of less than 10 mg\u002Fday prednisone (or equivalent to 10 mg\u002Fday prednisone) or for prevention of contrast dye allergy.\n7. Known symptomatic central nervous system (CNS) metastasis and\u002For spinal cord compression and\u002For carcinomatous meningitis, or a history of leptomeningeal carcinoma. Participants with asymptomatic CNS metastases (without neurological symptoms, without the need for corticosteroids or anticonvulsants, and with metastases all ≤ 1.5 cm in diameter) or with brain metastases that are stable after treatment and meet all of the following criteria may be considered for inclusion: (1) measurable lesions outside the CNS; (2) no midbrain, pons, cerebellum, meninges, medulla oblongata, or spinal cord metastases; (3) stable for at least 4 weeks with no new or enlarging metastases ( clearly confirmed by clinical symptoms, signs, and imaging evidence); (4) have discontinued corticosteroids and\u002For anticonvulsants for at least 2 weeks prior to the first dose of study drug and have recovered from the acute toxicity of radiotherapy. Whole brain radiotherapy or stereotactic radiotherapy must be completed at least 2 weeks prior to study randomization. CNS lesions should be monitored and examined regularly during the study.\n\n   Note: CNS lesions will not be considered target lesions.\n8. Non-remission of adverse events (AEs) after previous anti-cancer treatment, defined as AEs that have not been relieved to ≤ grade 1 or baseline before enrollment according to NCI-CTCAE v5.0 criteria (except for alopecia and pigmentation). Note: Participants with chronic, stable Grade 2 toxicities (defined as not worsening to \\>Grade 2 for at least 3 months prior to enrollment and manageable with standard of care) that were considered by the investigator to be related to prior anticancer therapy, e.g., fatigue, insomnia, hypomagnesemia, chemotherapy-induced peripheral neuropathy, hypothyroidism stably controlled by replacement therapy, and hypertension stably controlled below 160\u002F100 mmHg by antihypertensives, were eligible for study entry.\n9. Tumor invades surrounding important tissues and organs (such as mediastinal great vessels, superior vena cava and inferior vena cava, pericardium, heart, trachea, esophagus, etc.).\n10. Bleeding within 3 months prior to the first dose of study treatment that is life-threatening and requires blood transfusion or invasive treatment.\n11. Symptomatic abdominopelvic fluid collections, pleural effusions, or pericardial effusions requiring intervention (participants with stable controlled effusions, defined as clinically asymptomatic effusions that do not increase significantly with drain removal or no drainage, for at least 7 days, are allowed).\n12. Participants with varices in the esophagus or stomach that require immediate intervention (e.g., ligation or sclerotherapy), or who are considered by the investigator or a gastroenterologist or hepatologist to be at high risk for bleeding, have evidence of portal hypertension (including splenomegaly on imaging), or have a history of variceal bleeding, must have endoscopic assessment within 3 months prior to the first start of study treatment.\n13. Unhealed gastrointestinal obstruction, perforation, or fistula, or participants at risk of gastrointestinal obstruction or perforation (including but not limited to acute diverticulitis and abdominal abscess), or a history of extensive bowel resection (partial colectomy or extensive small bowel resection accompanied with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea. Note: The digestive tract refers to the muscular tube from the oral cavity to the anal canal, including the oral cavity, pharynx, esophagus, stomach, small intestine (duodenum, jejunum, and ileum), large intestine (cecum, appendix, colon, and rectum), and anal canal.\n14. After endoluminal stenting of the trachea and after stenting of the digestive tract, and the participant did not resume normal diet or defecation.\n15. Participants with biliary obstruction, unless local treatment for obstruction (e.g., endoscopic stent placement or percutaneous liver drainage) has been performed and TBIL has decreased to less than 1.5 × ULN.\n16. Hepatic encephalopathy, hepatorenal syndrome, or cirrhosis with Child-Pugh Class B or above.\n17. Significant malnutrition, such as malnutrition requiring parenteral nutrition; except for those who have not used intravenous nutrition within 4 weeks before the first study treatment.\n18. Uncontrolled active infection, including the following:\n\n    1. Infection requiring systemic antibiotic, antiviral, or antifungal therapy.\n    2. Human immunodeficiency virus (HIV) infection, or positive for HIV 1\u002F2 Ab.\n    3. Acute or chronic active hepatitis B, defined as hepatitis B surface antigen positive (regardless of the results of antibodies to other antigens) or hepatitis B core antibody positive only (hepatitis B surface antibody negative and hepatitis B e antibody negative), and hepatitis B virus (HBV) DNA ≥ 1 × 10 4 copies\u002FmL or ≥ 2000 IU\u002FmL; or acute or chronic active hepatitis C, defined as hepatitis C virus (HCV) antibody positive and HCV RNA titer above the lower limit of detection.\n    4. Active tuberculosis infection, or still receiving anti-tuberculosis treatment, or received anti-tuberculosis treatment within 1 year before the first dose of study drug.\n    5. Active syphilis infection or latent syphilis requiring treatment.\n19. History of immunodeficiency diseases, including congenital or acquired immunodeficiency diseases.\n20. History of allogeneic organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation (except corneal transplantation).\n21. Pregnant or lactating (may be considered if breastfeeding is discontinued) female participants, or participants planning to become pregnant.\n22. Ineligible for any drug under study. Participants with contraindications to trastuzumab, pertuzumab monoclonal antibody, taxanes according to local prescribing information or IBI354 per the IBI354 Investigator's Brochure cannot be enrolled in the study.\n23. Participant has known allergic or hypersensitivity reactions to the study treatments, camptothecin and its derivatives, other ADCs\u002Fanti-HER2 antibodies, and any excipients.\n24. Complicated with other primary malignant tumors within 3 years or other malignant tumors with active or recurrent risk, excluding radically resected non-melanoma skin cancer (mainly including squamous cell carcinoma of skin and basal cell carcinoma of skin), radically resected carcinoma in situ, and papillary thyroid carcinoma.\n25. Participation in any other interventional clinical study, except for observational (non-interventional) studies or follow-up period after the end of study treatment in interventional studies.\n26. Presence of substance abuse (excessive or inappropriate use of drugs, alcohol, or other harmful substances that may lead to physical, psychological, or social problems) or other acute or chronic diseases or laboratory abnormalities that, in the opinion of the investigator, may interfere with the participant's participation in the clinical study, increase the risk of study participation or drug administration, interfere with the interpretation of study results, or render the participant unsuitable for participation in the study in the judgment of the investigator.\n27. The participant has a neurologic, psychiatric, or psychological illness or social condition that would interfere with trial compliance, substantially increase the risk of adverse events, or prevent the participant from providing written informed consent.",{"count":120,"type":20},540,[24],"This is a randomized, multicenter, open-label, phase 3 study evaluating the efficacy, safety, and tolerability of IBI354 combined with or without pertuzumab vs. THP as first-line treatment for HER2-positive unresectable, locally advanced or metastatic breast cancer.",[124],"HER2-positive Breast Cancer","2026-02-23",{"date":127,"type":32},"2026-02-25",{"date":129,"type":32},"2026-02-10",{"date":131,"type":20},"2030-05-31",{"name":38,"class":39},{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":140,"maxAge":17,"enrollmentInfo":141,"targetDuration":4,"studyType":21,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":40},"100613338","phase-3-a-study-to-evaluate-efficacy-and-safety-of-ibi112-in-adolescent-participants-with-moderate-to-severe-plaque-psoriasis-100613338","NCT07265284","A Study to Evaluate Efficacy and Safety of IBI112 in Adolescent Participants With Moderate to Severe Plaque Psoriasis","A Phase Ⅰ\u002FⅢ Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Picankibart in Adolescent Patients With Moderate to Severe Plaque Psoriasis","Inclusion Criteria:\n\nMales or females aged 12 to 18 years; Diagnosed with plaque psoriasis and a history of psoriasis ≥6 months; suitable for phototherapy and\u002For systemic treatment for psoriasis.\n\nExclusion Criteria:\n\nHistory of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis Has received any therapeutic agent directly targeted to IL-17within 6 months of the first administration of study agent Has received any therapeutic agent directly targeted toTNF-a within 3 months of the first administration of study agent Has received any conventional therapeutic agent within 1 months of the first administration of study agent Has received any topic therapeutic agent within 2 weeks of the first administration of study agent Hsa received IBI112","12 Years",{"count":142,"type":20},104,[24],"The purpose of this study is to evaluate the efficacy and safety of IBI112 in the treatment of adolescent participants with moderate to severe plaque-type psoriasis.",[146],"Psoriasis","2025-12-19",{"date":149,"type":32},"2025-12-22",{"date":151,"type":32},"2025-12-03",{"date":153,"type":20},"2029-01-31",{"name":38,"class":39},{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":75,"enrollmentInfo":162,"targetDuration":4,"studyType":21,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},"100590120","phase-1-study-of-ibi3020-treatment-in-participants-with-late-stage-solid-tumors-100590120","NCT06963281","Study of IBI3020 Treatment in Participants With Late-Stage Solid Tumors","A Phase 1, Multicenter, Open-label Study of IBI3020 Treatment in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\nParticipants must satisfy all of the following criteria to be enrolled into the study:\n\n1. Participants have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;\n2. Male or female participants ≥ 18 years old. For Part 1, age ≥ 18 years and ≤ 75 years;\n3. Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumors which have received available standard therapies and have disease progression, or unacceptable toxic effects, or contraindications;\n4. At least 1 measurable lesion as defined per RECIST v1.1 within 28 days prior to the first dose of IBI3020;\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;\n6. Minimum life expectancy of 12 weeks;\n7. Adequate bone marrow and organ function confirmed at screening period;\n8. Participants, both male and female, who are not of childbearing potential or who agree to use at least 1 highly effective method of contraception during the study.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Previous treatment with CEACAM5-targeted therapy;\n2. Prior anti-cancer therapy within the wash-out period;\n3. Received live vaccines within 4 weeks or cancer vaccine within 3 months;\n4. Potent cytochrome P450 3A4 (CYP3A4) inhibitors within 2 weeks or 5 half-lives;\n5. 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;\n6. Known allergies, hypersensitivity, or intolerance to IBI3020 or its excipients;\n7. Undergone major surgery within 4 weeks, or who have severe unhealed wounds;\n8. Known symptomatic central nervous system (CNS) metastases;\n9. Uncontrolled diseases or conditions;\n10. History of pneumonitis requiring corticosteroids therapy, or history of clinically significant lung diseases;\n11. History of thromboembolic event within 6 months;\n12. Under neurological, psychiatric or social condition;\n13. Women who are pregnant, have positive results in pregnancy test or are lactating;\n14. Not eligible to participate in this study at the discretion of the investigator;\n15. Participating in any other interventional clinical research.",{"count":163,"type":20},285,[51],"The main purpose of this study is to evaluate the safety and tolerability of IBI3020 and to determine the maximum tolerated dose (MTD) and\u002For the recommended dose for expansion (RP2D) of IBI3020.",[167],"Solid Tumors","2025-06-03",{"date":170,"type":32},"2025-06-06",{"date":172,"type":32},"2025-04-29",{"date":174,"type":20},"2028-03-31",{"name":38,"class":39},9,""]