NCT07424287

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

A Multicenter, Randomized, Open-label Phase III Clinical Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Investigator-selected Chemotherapy In Patients With BCG-unresponsive High-risk Non-muscle-invasive Bladder Cancer (NMIBC) (NiBladder 1)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 high-risk non-muscle-invasive bladder cancer (NMIBC).

Conditions

• NMIBC

Interventions

Type	Name	Description
DRUG	SHR-1501 for Injection	SHR-1501 for injection.
DRUG	BCG for Injection	Bacillus calmette guerin (BCG) for injection.
DRUG	Epirubicin Hydrochloride for Injection	Epirubicin hydrochloride for injection.
DRUG	Pirarubicin Hydrochloride for Injection	Pirarubicin hydrochloride for injection.
DRUG	Gemcitabine Hydrochloride for Injection	Gemcitabine hydrochloride for injection.
DRUG	Hydroxycamptothecin for Injection	Hydroxycamptothecin for injection.
DRUG	Mitomycin for Injection	Mitomycin for injection.

Timeline

• Start date: 2026-03-01
• Primary completion: 2030-06-01
• Completion: 2030-06-01
• First posted: 2026-02-20
• Last updated: 2026-02-20

Locations

2 sites across 1 country: China