{"id":"disitamab-vedotin-combined-with-tislelizumab","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Peripheral neuropathy"},{"rate":null,"effect":"Immune-related adverse events (irAEs)"}]},"_chembl":{"chemblId":"CHEMBL5095273","moleculeType":"Antibody drug conjugate"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Disitamab vedotin is an antibody-drug conjugate (ADC) targeting HER2 that binds to HER2-positive tumor cells and releases a microtubule-disrupting agent intracellularly. Tislelizumab is a humanized PD-1 inhibitor that relieves T-cell exhaustion and promotes anti-tumor immunity. The combination leverages both direct cytotoxic killing and immune checkpoint blockade for enhanced efficacy.","oneSentence":"Disitamab vedotin delivers a cytotoxic payload to HER2-expressing cancer cells while tislelizumab simultaneously blocks PD-1 to enhance anti-tumor immune response.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:35:21.345Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HER2-positive gastric or gastroesophageal junction cancer"},{"name":"HER2-positive breast cancer (potential)"}]},"trialDetails":[{"nctId":"NCT07315750","phase":"PHASE3","title":"A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.","status":"RECRUITING","sponsor":"RemeGen Co., Ltd.","startDate":"2026-01-01","conditions":"Gastric Carcinoma","enrollment":555},{"nctId":"NCT05837806","phase":"PHASE2","title":"Efficacy and Safety of Tislelizumab in Combination With Disitamab-vedotin as Neoadjuvant Therapy for HER2-positive High-risk Upper Tract Urothelial Carcinoma (UTUC)","status":"RECRUITING","sponsor":"Tianjin Medical University Second Hospital","startDate":"2022-12-30","conditions":"Neoadjuvant Immunotherapy","enrollment":21},{"nctId":"NCT05912816","phase":"PHASE2","title":"Combination of DV and Tislelizumab for Renal Preservation in High-risk UTUC Patients","status":"RECRUITING","sponsor":"RenJi Hospital","startDate":"2023-06-10","conditions":"Upper Urinary Tract Urothelial Carcinoma, Kidney Preservation, HER-2 ADC","enrollment":20},{"nctId":"NCT06944496","phase":"PHASE3","title":"A Study of Disitamab Vedotin Combined With Tislelizumab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in HER2-Low Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","status":"NOT_YET_RECRUITING","sponsor":"RemeGen Co., Ltd.","startDate":"2025-05-15","conditions":"Gastric Carcinoma","enrollment":616},{"nctId":"NCT05586061","phase":"PHASE2","title":"First-line Treatment with RC48 Plus Tislelizumab and S-1(RCTS) in Advanced Gastric Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Qilu Hospital of Shandong University","startDate":"2023-02-10","conditions":"HER2-positive Gastric Cancer","enrollment":55},{"nctId":"NCT06749860","phase":"PHASE2","title":"Disitamab Vedotin in Combination with Tislelizumab and Bevacizumab in a Phase II Clinical Study of Locally Advanced or Metastatic Non-small Cell Lung Cancer with HER2 Mutation/amplification/expression","status":"RECRUITING","sponsor":"Shanghai Pulmonary Hospital, Shanghai, China","startDate":"2024-02-02","conditions":"Lung Cancer","enrollment":58},{"nctId":"NCT06630871","phase":"PHASE2","title":"A Clinical Trial Evaluating the Efficacy and Safety of Disitamab Vedotin Plus Tislelizumab Combined with Re-TURBT in the Treatment of HER-2-high Expression(2+-3+) Non-muscle Invasive Bladder Cancer At High-risk and Very High-risk.","status":"NOT_YET_RECRUITING","sponsor":"Fujian Medical University Union Hospital","startDate":"2024-10","conditions":"NMIBC","enrollment":40},{"nctId":"NCT06560528","phase":"PHASE2","title":"Disitamab Vedotin Combined With Tislelizumab and Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Cancer With HER2 Overexpression","status":"RECRUITING","sponsor":"Tianjin Medical University Cancer Institute and Hospital","startDate":"2024-09-01","conditions":"Gastric Cancer, Gastroesophageal Junction Adenocarcinoma","enrollment":40},{"nctId":"NCT05578287","phase":"PHASE2","title":"RC48 Plus Tislelizumab, Low-dose Capecitabine and Celecoxib for HER2-positive Metastatic Colorectal Cancer","status":"UNKNOWN","sponsor":"Sun Yat-sen University","startDate":"2023-07-18","conditions":"Colorectal Cancer","enrollment":29},{"nctId":"NCT05957757","phase":"PHASE2","title":"RC48 Combined With Tislelizumab for Bladder Sparing Treatment in NMIBC With BCG Treatment Failure and HER2 Expression","status":"RECRUITING","sponsor":"RenJi Hospital","startDate":"2023-08-05","conditions":"Non-Muscle Invasive Bladder Cancer, HER2","enrollment":20},{"nctId":"NCT05982834","phase":"PHASE1, PHASE2","title":"Disitamab Vedotin, Fruquintinib and Tislelizumab in Second-line Treatment for HER2-positive MGC","status":"UNKNOWN","sponsor":"Fudan University","startDate":"2023-05-09","conditions":"HER2-positive Gastric Cancer, Immunotherapy","enrollment":43},{"nctId":"NCT05861635","phase":"PHASE4","title":"The Study of Vidicizumab Combined With Tirelizumab in the Treatment of Breast Cancer With Low HER2 Expression","status":"UNKNOWN","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","startDate":"2023-02-01","conditions":"Breast Cancer, Neoadjuvant Therapy","enrollment":42},{"nctId":"NCT05847764","phase":"PHASE2","title":"Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations","status":"UNKNOWN","sponsor":"Sun Yat-sen University","startDate":"2023-05","conditions":"Non Small Cell Lung Cancer, ERBB2 Mutation-Related Tumors, RC48","enrollment":95},{"nctId":"NCT05493683","phase":"PHASE2","title":"Disitamab Vedotin Combined With Tislelizumab in Advanced HER2 Positive Colorectal Cancer","status":"UNKNOWN","sponsor":"The First Affiliated Hospital with Nanjing Medical University","startDate":"2022-08-01","conditions":"Colorectal Neoplasms","enrollment":29},{"nctId":"NCT05495724","phase":"PHASE2","title":"Disitamab Vedotin Combined With Tislelizumab for Her2 Overexpressing High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable","status":"UNKNOWN","sponsor":"Tianjin Medical University Second Hospital","startDate":"2021-07-23","conditions":"Her2 Overexpressing High-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma","enrollment":176}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":9,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Disitamab Vedotin combined with Tislelizumab","genericName":"Disitamab Vedotin combined with Tislelizumab","companyName":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","companyId":"union-hospital-tongji-medical-college-huazhong-university-of-science-and-technol","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Disitamab vedotin delivers a cytotoxic payload to HER2-expressing cancer cells while tislelizumab simultaneously blocks PD-1 to enhance anti-tumor immune response. Used for HER2-positive gastric or gastroesophageal junction cancer, HER2-positive breast cancer (potential).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}