A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy

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.

NCT Number	NCT07468851
Lead Sponsor	Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions	High-risk Non-muscle-invasive Bladder Cancer
Enrollment	180 participants
Start Date	2026-06-10
Primary Completion	2028-04-30 (estimated)
Study Completion	2029-04-30 (estimated)
Updated on ClinicalTrials.gov	2026-03-13