Clinical Trial

A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC

Recruiting Phase 3
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Summary
This is a multicenter, randomized, open-label phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus investigator-selected chemotherapy in patients with BCG-unresponsive papillary-only non-muscle-invasive bladder cancer (NMIBC).
Protocol Amendment History 2 changes
critical Recruitment opened 2026-07-21
critical Primary endpoint(s) modified 2026-06-03
Trial Details
NCT Number NCT07424287
Lead Sponsor Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions NMIBC
Enrollment 236 participants
Start Date 2026-07-13
Primary Completion 2030-06 (estimated)
Study Completion 2030-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-20