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A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UGN-301 (Zalifrelimab) Administered Intravesically as Monotherapy and in Combination With Other Agents in Patients With Recurrent NMIBC

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Trial Profile

A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UGN-301 (Zalifrelimab) Administered Intravesically as Monotherapy and in Combination With Other Agents in Patients With Recurrent NMIBC

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 02 May 2025

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At a glance

  • Drugs Imiquimod (Primary) ; Zalifrelimab (Primary)
  • Indications Bladder cancer; Carcinoma
  • Focus Adverse reactions; First in man; Pharmacokinetics; Therapeutic Use
  • Sponsors UroGen Pharma

Most Recent Events

  • 26 Apr 2025 According to a UroGen Pharma media release, presentation of data from the combination arms is planned for later this year.
  • 26 Apr 2025 Encouraging safety data from this Phase 1 dose-escalation study presented in the UroGen Pharma Media Release
  • 14 Apr 2025 According to a UroGen Pharma media release, data from this study will be presented at the American Urological Association (AUA) 2025 Annual Meeting being held in Las Vegas, Nevada from April 26-29.

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