{"id":"ibi354","safety":{"commonSideEffects":[{"rate":null,"effect":"Immune-related adverse events (irAEs)"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Infusion reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"By blocking PD-1, IBI354 relieves the inhibitory signal that tumors use to suppress T cell activation. Simultaneously, by neutralizing TGF-β, it reduces immunosuppressive signaling in the tumor microenvironment, thereby promoting a more robust anti-tumor immune response. This dual mechanism aims to overcome resistance to single-agent checkpoint inhibition.","oneSentence":"IBI354 is a bispecific antibody that simultaneously engages PD-1 on immune cells and TGF-β in the tumor microenvironment to enhance anti-tumor immunity.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:15:19.239Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-small cell lung cancer"},{"name":"Other solid tumors (in development)"}]},"trialDetails":[{"nctId":"NCT07377643","phase":"PHASE3","title":"IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer","status":"RECRUITING","sponsor":"Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.","startDate":"2026-02-10","conditions":"HER2-positive Breast Cancer","enrollment":540},{"nctId":"NCT06834672","phase":"PHASE3","title":"Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer","status":"RECRUITING","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","startDate":"2025-03-17","conditions":"Ovarian, Primary Peritoneal, Fallopian Tube Cancer","enrollment":450},{"nctId":"NCT05636215","phase":"PHASE1, PHASE2","title":"A First-in-human Study of IBI354 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors","status":"RECRUITING","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","startDate":"2023-04-04","conditions":"Locally Advanced Unresectable or Metastatic Solid Tumors","enrollment":368}],"_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":[],"phase":"phase_3","status":"active","brandName":"IBI354","genericName":"IBI354","companyName":"Innovent Biologics (Suzhou) Co. Ltd.","companyId":"innovent-biologics-suzhou-co-ltd","modality":"Biologic","firstApprovalDate":"","aiSummary":"IBI354 is a bispecific antibody that simultaneously engages PD-1 on immune cells and TGF-β in the tumor microenvironment to enhance anti-tumor immunity. Used for Non-small cell lung cancer, Other solid tumors (in development).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}