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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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Start date changed from estimate of Jun 10, 2026 to Aug 5, 2026 · Eligibility criteria shortened, about 55 words · Site details revised at 2 of 2 sitesv2 Show 3 more changesShow less
    • Start date changed from estimate of Jun 10, 2026 to Aug 5, 2026
    • Eligibility criteria shortened, about 55 words
    • Site details revised at 2 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07468851
Lead Sponsor Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions High-risk Non-muscle-invasive Bladder Cancer
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov