{"id":"js004-in-combination-with-toripalimab","safety":{"commonSideEffects":[{"rate":null,"effect":"Immune-related adverse events (irAEs) including colitis, pneumonitis, hepatitis"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Rash"},{"rate":null,"effect":"Diarrhea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"JS004 blocks CTLA-4, a negative regulator of T-cell activation, while toripalimab blocks PD-1, another inhibitory checkpoint. Together, they remove multiple brakes on the immune system, allowing T cells to more effectively recognize and attack cancer cells. This dual checkpoint inhibition approach is designed to overcome resistance to single-agent immunotherapy.","oneSentence":"JS004 is a CTLA-4 inhibitor that blocks immune checkpoint signaling, and when combined with toripalimab (a PD-1 inhibitor), it provides dual checkpoint blockade to enhance anti-tumor immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:17:39.770Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Advanced or metastatic solid tumors (Phase 3 development)"}]},"trialDetails":[{"nctId":"NCT05427396","phase":"PHASE1","title":"A Phase I Clinical Study of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined With Toripalimab Injection in Patients With Advanced Solid Tumors","status":"TERMINATED","sponsor":"Shanghai Junshi Bioscience Co., Ltd.","startDate":"2022-07-28","conditions":"Liver Cancer, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Cervical Cancer, MSI-H Colorectal Cancer","enrollment":31},{"nctId":"NCT05664971","phase":"PHASE1, PHASE2","title":"JS004 Combined With Toripalimab and With Standard Chemotherapy Treat Patients With Advanced Lung Cancer","status":"COMPLETED","sponsor":"Shanghai Junshi Bioscience Co., Ltd.","startDate":"2023-02-09","conditions":"Advanced Lung Cancer","enrollment":119},{"nctId":"NCT06730932","phase":"PHASE2","title":"A Prospective，Single Arm, Multicenter Clinical Study of BTLA Monoclonal Antibody JS004 (B/T Lymphocyte Attenuator Factor Monoclonal Antibody) in Combination With Toripalimab in Patients With Unresectable or Advanced Renal Cell Carcinoma Who Had Failed Previous Immunotherapy","status":"NOT_YET_RECRUITING","sponsor":"RenJi Hospital","startDate":"2025-10-30","conditions":"Unresectable or Advanced Clear Cell Renal Cell Carcinoma That Has Progressed After Previous Immunotherapy","enrollment":31},{"nctId":"NCT07101614","phase":"PHASE2","title":"A Randomized Study of JS004 and Toripalimab Combined With Chemotherapy vs Toripalimab Combined With Chemotherapy vs Chemotherapy Alone as Neoadjuvant Therapy for Stage II-III Triple-negative Breast Cancer (TNBC).","status":"NOT_YET_RECRUITING","sponsor":"Shengjing Hospital","startDate":"2025-09-01","conditions":"TNBC - 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