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

StatusRecruiting
PhasePhase 3
Started2026-07-13
View on ClinicalTrials.gov ↗

Amendment history

2026-07-16
Study Status, Contacts/Locations v2
Recruitment opened
Start dateestimated 2026-06→confirmed 2026-07-13
Study sitesdetails revised at 2 of 2 sites
2026-05-29
Study Identification, Study Status, Study Description, Outcome Measures, Eligibility v1
Primary endpoint(s) modified1 entry, revised
WasEvent-Free Survival (EFS)
NowDisease-Free Survival (DFS) assessed by Blinded Independent Central Review (BICR)
Start date2026-03→2026-06
Eligibility criteria+52 characters
[...] confirmation of high-risk non-muscle invasive bladder cancer (high-grade Ta and/or any T1, no carcinoma in situ); BCG-unresponsive; Cystoscopy within 6 weeks before the ran [...]
Secondary endpoints6 to 4 entries
Complete response (CR) rate Duration of Response (DoR) Disease-Free Survival (DFS) assessed by investigator
2026-02-13
Original filing
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).
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