{"id":"datopotamab","rwe":[{"n":null,"pmid":"40367401","year":"2025","title":"Decoding Clinical Trials in Metastatic Breast Cancer: Practical Insights for Optimal Therapy Sequencing.","finding":"1. Am Soc Clin Oncol Educ Book. 2025 Jun;45(3):e100053. doi: 10.1200/EDBK-25-100053. Epub 2025 May 14. Decoding Clinical Trials in Metastatic Breast Cancer: Practical Insights for Optimal Therapy Sequencing. Corti C(1)(2)(3)(4)(5), Rugo HS(6)(7), Tolaney SM(1)(2)(3). Author information: (1)Departmen","journal":"American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annua","studyType":"Observational"},{"n":null,"pmid":"40700616","year":"2025","title":"Datopotamab deruxtecan-associated select adverse events: clinical practices and institutional protocols on prophylaxis, monitoring, and management.","finding":"","journal":"The oncologist","studyType":"Observational"}],"tags":[],"phase":"phase_1","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{"Pregnancy":"8.1 Pregnancy Risk Summary Based on its mechanism of action, DATROWAY can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of DATROWAY, DXd, is genotoxic and affects actively dividing cells [see Clinical Pharmacology (12.1) , Nonclinical Toxicology (13.1) ] . There are no available data on the use of DATROWAY in pregnant women to inform a ","Paediatric use":"8.4 Pediatric Use Safety and effectiveness of DATROWAY have not been established in pediatric patients.","Elderly (≥65 years)":"8.5 Geriatric Use Of the 125 patients with EGFR-mutated NSCLC in TROPION-Lung05, TROPION-Lung01, TROPION-PanTumor01 treated with DATROWAY 6 mg/kg, 44% were ≥65 years of age and 10% were ≥75 years of age. No clinically meaningful differences in efficacy and safety were observed between patients ≥65 years of age versus younger patients. Of the 365 patients in TROPION-Breast01 treated with DATROWAY 6"},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT05555732","NCT06533826","NCT06508216","NCT05117476","NCT07471776","NCT06417814","NCT06357533","NCT05489211","NCT04526691","NCT03401385","NCT06974604","NCT07474558","NCT06279728","NCT05460273","NCT05104866","NCT04612751","NCT06954480","NCT04484142","NCT06564844","NCT06350097","NCT04656652","NCT05866432","NCT05215340","NCT05374512","NCT05629585","NCT06244485","NCT06103864","NCT06822543","NCT01042379","NCT05417594","NCT07291037","NCT04940325","NCT05061550","NCT03742102","NCT06676917","NCT07129993","NCT03944772","NCT04644068","NCT06112379","NCT07357597","NCT07069595","NCT05687266","NCT06176261"],"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"2023","type":"neutral","milestone":"Phase 2 Initiated","description":"A Study of Dato-DXd in Chinese Patients With Advanced Non-Small Cell Lung Cancer, Triple-negative Br — Carcinoma, Non-Small-Cell Lung"},{"date":"2025","type":"neutral","milestone":"Phase 3 Initiated","description":"A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Ino — Breast Cancer"},{"date":"2026","type":"neutral","milestone":"Phase 1 Initiated","description":"Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced — Advanced or Metastatic NSCLC"}],"brandName":"DATOPOTAMAB","companyId":"unknown","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"Monoclonal antibody","drugClass":"Trop-2-directed antibody-drug conjugate","explanation":"12.1 Mechanism of Action Datopotamab deruxtecan-dlnk, is a Trop-2-directed antibody-drug conjugate. The antibody is a humanized anti-Trop2 IgG1. The small molecule, DXd, is a topoisomerase I inhibitor attached to the antibody by a cleavable linker. Following binding to Trop-2 on cells, including tumor cells, datopotamab deruxtecan-dlnk undergoes internalization and intracellular linker cleavage by lysosomal enzymes. Upon release, the membrane-permeable DXd causes DNA damage and apoptotic cell de","oneSentence":"12.1 Mechanism of Action Datopotamab deruxtecan-dlnk, is a Trop-2-directed antibody-drug conjugate.","technicalDetail":"12.1 Mechanism of Action Datopotamab deruxtecan-dlnk, is a Trop-2-directed antibody-drug conjugate. The antibody is a humanized anti-Trop2 IgG1. The small molecule, DXd, is a topoisomerase I inhibitor attached to the antibody by a cleavable linker. Following binding to Trop-2 on cells, including tumor cells, datopotamab deruxtecan-dlnk undergoes internalization and intracellular linker cleavage by lysosomal enzymes. Upon release, the membrane-permeable DXd causes DNA damage and apoptotic cell death. Datopotamab deruxtecan-dlnk had anti-tumor activity in mouse models of lung cancer including EGFR-mutated and breast cancer."},"commercial":null,"references":[],"biosimilars":[],"companyName":"","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"}],"genericName":"DATOPOTAMAB","indications":{"approved":[],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT05555732","phase":"Phase 3","title":"A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in Subjects With No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-","status":"ACTIVE_NOT_RECRUITING","sponsor":"Daiichi Sankyo","isPivotal":true,"enrollment":1170,"indication":"Metastatic Non Small Cell Lung Cancer","completionDate":"2029-05-11"},{"nctId":"NCT06533826","phase":"Phase 2","title":"A Phase II Non-comparative Trial of Datopotamab Deruxtecan (Dato-DXd) or Trastuzumab Deruxtecan (T-DXd) in Patients With Metastatic HER2-negative (HER2-low or HER2-0) Breast Cancer After Progression o","status":"RECRUITING","sponsor":"Ana C Garrido-Castro, MD","isPivotal":false,"enrollment":357,"indication":"Breast Cancer, HER2-low Breast Cancer","completionDate":"2038-08-01"},{"nctId":"NCT06508216","phase":"Phase 1","title":"A Phase Ib/II, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relaps","status":"RECRUITING","sponsor":"Gustave Roussy, Cancer Campus, Grand Paris","isPivotal":false,"enrollment":50,"indication":"Breast Cancer","completionDate":"2027-12-17"},{"nctId":"NCT05117476","phase":"Phase 1","title":"A Phase 1 Dose-Escalation Study to Investigate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamic Activity of CLN-619 (Anti-MICA/MICB Antibody) Alone 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Breast Cancer Brain metAstaSEs","status":"RECRUITING","sponsor":"Sarah Sammons, MD","isPivotal":false,"enrollment":58,"indication":"Breast Cancer, Breast Cancer Female","completionDate":"2029-01-01"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"Intravenous","frequency":"Every 3 weeks","formulation":"Vial (infusion)"},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Monoclonal antibody","aiSummary":"Datopotamab deruxtecan is an antibody drug conjugate that targets tumor-associated calcium signal transducer 2. It is being studied in clinical trials for various conditions, including non-small cell lung cancer, triple negative breast cancer, stomatitis, and advanced solid tumors.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":18,"withResults":2},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}