[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bladder-ca\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bladder-ca":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":38,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":61},"100659924","phase-3-bl-m07d1-trastuzumab-brengitecan-t-bren-vs-standard-of-care-platinum-based-chemotherapy-pbc-for-her2-expressing-metastatic-urothelial-cancer-after-progression-on-anti-pd-l1-based-therapy-100659924",false,"NCT07869836","BL-M07D1 (Trastuzumab Brengitecan T-bren) vs Standard of Care Platinum-based Chemotherapy (PBC) for HER2-expressing Metastatic Urothelial Cancer After Progression on Anti-PD-(L)1-based Therapy","A Phase 3 Open-Label, Randomized Controlled Trial of T-bren (BL M07D1) vs. Platinum-based Chemotherapy in Patients With HER2 Expressing Metastatic Urothelial Cancer With Disease Progression on or After Anti-PD-(L)1-based Therapy","Inclusion Criteria:\n\n* Histologically or cytologically documented metastatic or surgically unresectable transitional cell carcinoma (TCC) of the urothelium involving the renal pelvis, ureter, bladder, or urethra. Minor histologic variants (ie, \\\u003C50% overall) are acceptable, provided that TCC is the dominant histology.\n* Disease progression or recurrence during or following anti-PD-(L)1-based therapy.\n* Fresh biopsy or archival tumor samples.\n* Documented HER2 expression by central laboratory testing.\n* Eligible to receive carboplatin or cisplatin in combination with gemcitabine.\n* At least 1 measurable lesion based on RECIST v1.1.\n* An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.\n* Adequate organ function.\n* Adequate coagulation parameters.\n\nExclusion Criteria:\n\n* Prior topoisomerase inhibitor-based ADC therapy.\n* Primary tumors in the central nervous system (CNS), active or untreated CNS metastases, or carcinomatous meningitis.\n* Bladder cancers with small cell histology.\n* Other prior or concurrent malignancies except for certain localized cancers or low-grade prostate cancer (if approved by sponsor), or other malignancy treated with curative intent with a disease-free interval of at least 3 years.\n* Prior history of clinically significant bleeding, or perforation of the gastrointestinal tract within 6 months of randomization.\n* Active autoimmune diseases and inflammatory diseases.\n* History of noninfectious interstitial lung disease (ILD)\u002Fpneumonitis that required treatment with steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening.\n* Advanced\u002Fclinically significant lung disease (eg, poorly controlled chronic obstructive pulmonary disease or asthma, restrictive lung disease, or pulmonary hypertension) within 6 months prior to randomization.\n* Known human immunodeficiency virus infection.\n* Active hepatitis B virus (HBV) infection.\n* Active hepatitis C virus (HCV) infection.\n* Active or latent tuberculosis.\n* Other protocol-specified inclusion\u002F exclusion criteria apply","ALL","18 Years",{"count":19,"type":20},520,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The objective of the study is to evaluate the efficacy and safety of T-bren in participants with HER2 expressing metastatic UC with progression on or after anti-PD-(L)1-based therapy.",[26,27,28,29,30,31,32,33,34,35,36,37],"Urothelial Cancer","Metastatic Urothelial Cancer","Bladder Cancer","Bladder Cancer (BC)","Bladder (Urothelial, Transitional Cell) Cancer","Bladder (Urothelial, Transitional Cell) Cancer Metastatic or Unresectable","Bladder Ca","Bladder Cancer Recurrent","Bladder Cancer Stage IV","Urothelial Carcinoma Bladder","Urothelial Carcinoma Recurrent","Urothelial Carcinoma of the Urinary Bladder",[39,40,41,42,43,44,45,46,47,48],"Bladder","Urothelial","ADC","T-bren","HER2","Metastatic","Second line","Third line","Targeted Therapy","Antibody drug conjugate","RECRUITING","2026-10-06",{"date":52,"type":53},"2026-10-13","ACTUAL",{"date":55,"type":20},"2026-09",{"date":57,"type":20},"2029-12",{"name":59,"class":60},"SystImmune Inc.","INDUSTRY",2]