Clinical Trial

Phase II Study of Trastuzumab Rezetecan or in Combination With Adebrelimab in HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC)

Study acronym: TRAIN-UC-01
Recruiting Phase 2
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Summary
This is a multicenter, open-label, Phase II clinical trial to evaluate the efficacy and safety of Trastuzumab Rezetecan (SHR-A1811) or in combination with Adebrelimab (SHR-1316) for HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-11-20; most recent amendment 2026-04-29.
Trial Details
NCT Number NCT07241793
Lead Sponsor Sun Yat-sen University
Collaborators: The fifth Affiliated Hospital of Guangzhou Medcial University, The Second Affiliated Hospital of Kunming Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Tongji Hospital
Conditions Urothelial Carcinoma, Advanced Urothelial Carcinoma, Urothelial Carcinoma Recurrent
Enrollment 96 participants
Start Date 2025-11-20
Primary Completion 2028-07-01 (estimated)
Study Completion 2031-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-30