{"id":"vic-trastuzumab-duocarmazine","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Neutropenia"},{"rate":null,"effect":"Thrombocytopenia"}]},"_chembl":{"chemblId":"CHEMBL4298178","moleculeType":"Antibody drug conjugate"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The drug combines trastuzumab (anti-HER2 monoclonal antibody) with duocarmycin, a potent DNA alkylating agent, via a cleavable linker. Upon binding to HER2 on cancer cells, the conjugate is internalized and the duocarmycin payload is released intracellularly, causing DNA damage and cell death. This targeted delivery mechanism aims to maximize efficacy while reducing systemic toxicity compared to unconjugated chemotherapy.","oneSentence":"Trastuzumab duocarmazine is an antibody-drug conjugate that binds HER2-positive cancer cells and delivers a DNA-damaging payload intracellularly.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:54:50.369Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HER2-positive breast cancer"},{"name":"HER2-positive gastric cancer"}]},"trialDetails":[{"nctId":"NCT01042379","phase":"PHASE2","title":"I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer","status":"RECRUITING","sponsor":"QuantumLeap Healthcare Collaborative","startDate":"2010-03-01","conditions":"Breast Neoplasms, Breast Cancer, Breast Tumors","enrollment":5000},{"nctId":"NCT04205630","phase":"PHASE2","title":"SYD985 in Patients With HER2-expressing Recurrent, Advanced or Metastatic Endometrial Carcinoma","status":"COMPLETED","sponsor":"Byondis B.V.","startDate":"2020-05-28","conditions":"Endometrial Cancer","enrollment":64},{"nctId":"NCT04983238","phase":"PHASE1, PHASE2","title":"Evaluation of Safety and Efficacy of Sodium Thiosulfate (BYON5667) Eye Drops to Reduce Ocular Toxicity in Cancer Patients Treated With SYD985","status":"COMPLETED","sponsor":"Byondis B.V.","startDate":"2022-01-10","conditions":"Metastatic Breast Cancer","enrollment":48},{"nctId":"NCT04235101","phase":"PHASE1","title":"Phase I Study of SYD985 With Niraparib in Patients With Solid Tumors","status":"COMPLETED","sponsor":"Byondis B.V.","startDate":"2020-06-22","conditions":"Solid Tumor","enrollment":32},{"nctId":"NCT04602117","phase":"PHASE1","title":"ISPY-P1.01:Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer","status":"WITHDRAWN","sponsor":"QuantumLeap Healthcare Collaborative","startDate":"2021-07-28","conditions":"HER2-positive Breast Cancer, HER2 Low, SYD-985","enrollment":""},{"nctId":"NCT03262935","phase":"PHASE3","title":"SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer","status":"COMPLETED","sponsor":"Byondis B.V.","startDate":"2017-12-15","conditions":"Metastatic Breast Cancer","enrollment":437}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["SYD985","Trastuzumab vc-seco-DUBA"],"phase":"phase_3","status":"active","brandName":"(vic-)trastuzumab duocarmazine","genericName":"(vic-)trastuzumab duocarmazine","companyName":"Byondis B.V.","companyId":"byondis-b-v","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Trastuzumab duocarmazine is an antibody-drug conjugate that binds HER2-positive cancer cells and delivers a DNA-damaging payload intracellularly. Used for HER2-positive breast cancer, HER2-positive gastric cancer.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}