drugset / Trial / NCT07445308
The Study is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With NMIBC, and to Determine the RP2D of SPGL008 Alone or in Combination With BCG.To Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG.
Phase 1/2
Not yet recruiting
120 enrolled
Shenyang Sunshine Pharmaceutical Co., LTD.
Shenzhen Sciprogen Bio-pharmaceutical Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
The goal of clinical trial is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With on-Muscle-Invasive Bladder Cancer. The main questions it aims to answer are: 1. Determine the recommend Phase II dose of SPGL008 Alone or in Combination With BCG.To 2. Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG.
Timeline
- Start
- 2026-03-12
- Primary completion
- 2028-11-21
- Completion
- 2029-12-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SPGL008 | Unknown | — | — |