clinical trial · NCT07424287
A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC
Suzhou Suncadia Biopharmaceuticals Co., Ltd.·phase3·not yet recruiting·n = 236
NMIBCSHR-1501 for InjectionBCG for InjectionEpirubicin Hydrochloride for InjectionPirarubicin Hydrochloride for InjectionGemcitabine Hydrochloride for InjectionHydroxycamptothecin for InjectionMitomycin for Injection
brief 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).
started
Mar 1, 2026
primary completion
Jun 1, 2030
completion
Jun 1, 2030
last updated
Feb 20, 2026
official title
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)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol