drugset / Trial / NCT07726992

A Study of SHR-1501 Combination With BCG Versus Placebo Combined With BCG in Subjects With Papillary-Only NMIBC

NCT07726992 ↗

Phase 3 Recruiting 750 enrolled Suzhou Suncadia Biopharmaceuticals Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multicenter, randomized, Double-blind phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus Placebo Combined with BCG in patients with high-risk BCG-naive Papillary-Only non-muscle-invasive bladder cancer (NMIBC)

Timeline

Start
2026-08-25
Primary completion
2029-12
Completion
2030-08

Drugs

EvaluationDrugModalityDoseRoute
Subject SHR-1501 Unknown — Intrathecal
Background Bacillus Calmette-Guérin Vaccine — —