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.

Trial Details

NCT ID
NCT07468851
Phase
PHASE1 / PHASE2
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • HS-10566
Locations (sample)
  • Beijing, China|39.9075,116.39723
  • Nanjing, China|32.06167,118.77778

Key Eligibility Criteria

  • Men or women aged greater than or equal to (≥) 18 years.
  • Signed informed consent form.
  • Histologically confirmed non-muscle-invasive bladder urothelial carcinoma (i.e., transitional cell carcinoma). Mixed tumor types predominantly cons…
  • Patients with non-muscle-invasive bladder cancer (NMIBC) who have undergone prior transurethral resection of bladder tumor (TURBT) and who refuse o…

For full eligibility, visit ClinicalTrials.gov.

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