{"id":"ibi363","safety":{"commonSideEffects":[{"rate":null,"effect":"Immune-related adverse events (irAEs)"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Rash"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"IBI363 functions as a bispecific monoclonal antibody designed to block two immune checkpoint pathways simultaneously. By targeting both PD-1 and TIM-3, the drug aims to overcome resistance mechanisms that allow tumors to evade immune surveillance, thereby enhancing T cell activation and proliferation against cancer cells.","oneSentence":"IBI363 is a bispecific antibody that simultaneously engages PD-1 on immune cells and TIM-3 on T cells to enhance anti-tumor immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:15:28.851Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Advanced or metastatic solid tumors (Phase 3 development)"}]},"trialDetails":[{"nctId":"NCT07217301","phase":"PHASE3","title":"IBI363 vs Docetaxel in Patients With Advanced Squamous Lung Cancer After Standard Treatments Have Failed","status":"RECRUITING","sponsor":"Fortvita Biologics (USA)Inc.","startDate":"2025-11-26","conditions":"iO Resistant sqNSCLC","enrollment":600},{"nctId":"NCT05290597","phase":"PHASE1","title":"A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects With Advanced Solid Malignancies or Lymphomas","status":"ACTIVE_NOT_RECRUITING","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","startDate":"2022-08-22","conditions":"Solid Malignancies or Lymphomas","enrollment":40},{"nctId":"NCT07408635","phase":"PHASE2","title":"IBI363 (PD-1/IL-2α-bias) in Combination With Chemotherapy as Neoadjuvant Therapy in Initially Unresectable Stage III Non-Small Cell Lung Cancer","status":"RECRUITING","sponsor":"Shanghai Pulmonary Hospital, Shanghai, China","startDate":"2026-01-07","conditions":"Unresectable Stage III Non-small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung Cancer (NSCLC)","enrollment":43},{"nctId":"NCT07402070","phase":"PHASE2","title":"IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer","status":"NOT_YET_RECRUITING","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","startDate":"2026-02-04","conditions":"Resectable Stage II-III Non-small Cell Lung Cancer","enrollment":10},{"nctId":"NCT07361991","phase":"PHASE1, PHASE2","title":"IBI363 Plus Bevacizumab With or Without Nab-Paclitaxel for Second-Line Treatment of Advanced Gastric Cancer","status":"NOT_YET_RECRUITING","sponsor":"The First Affiliated Hospital of Zhengzhou University","startDate":"2026-03","conditions":"Advan'ce'd, Advanced","enrollment":50},{"nctId":"NCT07342725","phase":"PHASE1, PHASE2","title":"Phase Ib/II Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Chemotherapy as Second-Line Therapy for Unresectable Locally Advanced or Metastatic Pancreatic Cancer","status":"NOT_YET_RECRUITING","sponsor":"Ruijin Hospital","startDate":"2026-01-01","conditions":"Pancreatic Cancer Metastatic","enrollment":48},{"nctId":"NCT07325630","phase":"PHASE2","title":"Perioprative Study of IBI363 in Patients With MHC-II-Negative Locally Advanced Gastric Cancer","status":"RECRUITING","sponsor":"Zhejiang Cancer Hospital","startDate":"2025-11-03","conditions":"IBI363 + Chemotherapy","enrollment":60},{"nctId":"NCT07307053","phase":"PHASE1, PHASE2","title":"Rare Tumor Focused Platform Study of Innovative Therapies and Technologies (PLATFORM2)","status":"NOT_YET_RECRUITING","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","startDate":"2026-01-01","conditions":"Rare Malignant Neoplasm, Advanced Solid Tumors, Metastatic Solid Tumors","enrollment":600},{"nctId":"NCT07289048","phase":"PHASE2","title":"A Prospective, Single-Arm, Exploratory Study of IBI363 in ES-SCLC Patients After Immunotherapy Progression","status":"NOT_YET_RECRUITING","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","startDate":"2025-12-20","conditions":"SCLC,Extensive Stage","enrollment":35},{"nctId":"NCT07122687","phase":"PHASE2","title":"IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer","status":"RECRUITING","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","startDate":"2025-08-26","conditions":"Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer","enrollment":170},{"nctId":"NCT07124793","phase":"PHASE2","title":"A Study of IBI363 Combination Therapy in Participants With Advanced Solid Tumors","status":"NOT_YET_RECRUITING","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","startDate":"2025-08-31","conditions":"EGFR Mutant NSCLC and Platinum Resistant Ovarian Cancer","enrollment":60},{"nctId":"NCT06081920","phase":"PHASE2","title":"A Study of IBI363 in Subjects With Advanced Melanoma","status":"RECRUITING","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","startDate":"2023-10-19","conditions":"Melanoma","enrollment":150},{"nctId":"NCT06946745","phase":"","title":"Exploration of the Dynamic Changes and Mechanisms of the Immune Microenvironment in Advanced Colorectal Cancer Treated With IBI363 Combination Therapy","status":"RECRUITING","sponsor":"jianming xu","startDate":"2024-12-02","conditions":"Immunotherapy","enrollment":50},{"nctId":"NCT06797297","phase":"PHASE2","title":"A Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal or Acral Melanoma Who Had Not Previously Received Systemic Therapy","status":"RECRUITING","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","startDate":"2025-02-24","conditions":"Melanoma","enrollment":180},{"nctId":"NCT06717880","phase":"PHASE1","title":"A Study of IBI363 in Combination With Bevacizumab or Furuitinib in Subjects With Advanced Colorectal Cancer","status":"RECRUITING","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","startDate":"2023-07-28","conditions":"Advanced Malignancies","enrollment":260},{"nctId":"NCT06281678","phase":"PHASE2","title":"A Study of IBI363 in Subjects with Advanced Solid Malignancies","status":"RECRUITING","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","startDate":"2024-04-08","conditions":"Melanoma, Non-small Cell Lung Cancer, Colorectal Cancer","enrollment":178},{"nctId":"NCT06610799","phase":"PHASE1","title":"Study of IBI363 in Patients with Advanced First-line Gastric Cancer","status":"RECRUITING","sponsor":"Xiangdong Cheng","startDate":"2024-10-15","conditions":"IBI363 + Chemotherapy","enrollment":40},{"nctId":"NCT06620822","phase":"PHASE2","title":"Efficacy of PD-1 Inhibitor Combination Therapy in Non-small Cell Lung Cancer Patients Who Have Not Achieved Major Pathologic Response After Neoadjuvant Immunotherapy: a Multicenter, Phase II Clinical Trial","status":"NOT_YET_RECRUITING","sponsor":"Shanghai Pulmonary Hospital, Shanghai, China","startDate":"2024-09-30","conditions":"Non Small Cell Lung Cancer","enrollment":296},{"nctId":"NCT06468098","phase":"PHASE1","title":"A Study of IBI363 in Subjects With Advanced Malignancies","status":"RECRUITING","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","startDate":"2024-06-15","conditions":"Advanced Malignancies","enrollment":556},{"nctId":"NCT06081907","phase":"PHASE1, PHASE2","title":"The Efficacy and Safety of IBI363 in Solid Tumors","status":"RECRUITING","sponsor":"Hunan Province Tumor Hospital","startDate":"2023-12-25","conditions":"Advanced Solid Tumor","enrollment":430},{"nctId":"NCT05460767","phase":"PHASE1","title":"Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma","status":"UNKNOWN","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","startDate":"2022-08-31","conditions":"Solid Tumors or Lymphoma","enrollment":260}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["IBI325","Lenvatinib","No other name"],"phase":"phase_3","status":"active","brandName":"IBI363","genericName":"IBI363","companyName":"Innovent Biologics (Suzhou) Co. Ltd.","companyId":"innovent-biologics-suzhou-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"IBI363 is a bispecific antibody that simultaneously engages PD-1 on immune cells and TIM-3 on T cells to enhance anti-tumor immune responses. Used for Advanced or metastatic solid tumors (Phase 3 development).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}