drugset / Trial / NCT06186414
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in NMIBC
Phase 1
Recruiting
152 enrolled
Jiangsu Simcere Pharmaceutical Co., Ltd.
Shanghai Xianxiang Medical Technology Co., Ltd. · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This is an open-label, multicenter phase 1 study to evaluate the safety, efficacy, and pharmacokinetics (PK) characteristics of SIM0237 alone or in combination with bacillus Calmette-Guerin (BCG) in participants with Non-Muscle-Invasive Bladder Cancer (NMIBC)
Timeline
- Start
- 2024-01-23
- Primary completion
- 2027-01
- Completion
- 2030-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SIM0237 | Unknown | — | Other |
| Subject | bacillus Calmette-Guerin | Unknown | — | Other |