RecruitingPhase 1Phase 2NCT07468851

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

A Phase I/II Clinical Study Evaluating the Safety, Efficacy, Tolerability, and Pharmacokinetics of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Enrollment

180 participants

Start Date

Aug 5, 2026

Study Type

INTERVENTIONAL

Conditions

High-risk Non-muscle Invasive Bladder Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called HS-10566, a drug called HS-10566, and others for people with high-risk non-muscle invasive bladder cancer. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHS-10566

HS-10566 is an intravesical gemcitabine delivery system available in two drug-loaded strengths: 0.3 g gemcitabine and 0.6 g gemcitabine.

DRUGHS-10566

HS-10566 is an intravesical gemcitabine delivery system available in two drug-loaded strengths: 0.3 g gemcitabine and 0.6 g gemcitabine.

DRUGHS-10566

HS-10566 is an intravesical gemcitabine delivery system available in two drug-loaded strengths: 0.3 g gemcitabine and 0.6 g gemcitabine.

Locations(2)

Peking University First Hospital

Beijing, China

Nanjing Drum Tower Hospital

Nanjing, China

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NCT07468851

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