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

NCT07468851 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-03-13

No results posted yet for this study

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.

Conditions

  • High-risk Non-muscle-invasive Bladder Cancer

Interventions

DRUG

HS-10566

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

DRUG

HS-10566

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

DRUG

HS-10566

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

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-10
Primary Completion
2028-04-30
Completion
2029-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07468851 on ClinicalTrials.gov