drugset / Trial / NCT07424287
A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2026-07-13
- Primary completion
- 2030-06
- Completion
- 2030-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bacillus calmette guerin | Unknown | — | Other |
| Comparator | Epirubicin | Small molecule | — | — |
| Comparator | Gemcitabine | Small molecule | — | — |
| Comparator | Hydroxycamptothecin | Small molecule | — | — |
| Comparator | Mitomycin C | Other / unclassified | — | — |
| Comparator | Pirarubicin | Small molecule | — | — |
| Subject | SHR-1501 | Unknown | — | Other |