drugset / Trial / NCT07468851
A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter, open-label, Phase I/II clinical study evaluating the safety, efficacy, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profiles of HS-10566 in patients with high-risk non-muscle-invasive bladder cancer who are ineligible for or refuse radical cystectomy. The study comprises two distinct phases: a dose exploration phase and a proof-of-concept phase.
Timeline
- Start
- 2026-06-10
- Primary completion
- 2028-04-30
- Completion
- 2029-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HS-10566 | Unknown | 0.3 g | Other |
| Subject | HS-10566 | Unknown | 0.6 g | Other |