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A Phase Ⅰ, Open Label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy

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Trial Profile

A Phase Ⅰ, Open Label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 25 Mar 2025

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At a glance

  • Drugs RAG 01 (Primary)
  • Indications Bladder cancer; Carcinoma
  • Focus Adverse reactions; First in man
  • Sponsors Ractigen Therapeutics

Most Recent Events

  • 24 Mar 2025 According to a Ractigen Therapeutics media release, the company announced the presentation of positive preliminary data from the study in a late breaking session at the 40th Annual Congress of the European Association of Urology (EAU 2025) in Madrid, Spain.
  • 24 Mar 2025 Results published in the Media Release
  • 26 Apr 2024 According to a Ractigen Therapeutics media release, the U.S. Food and Drug Administration (FDA) has approved the company's Investigational New Drug (IND) application for RAG-01, targeting non-muscle invasive bladder cancer (NMIBC). This approval facilitates the launch of U.S. clinical trials, following the successful initiation of a Phase I trial in Australia.

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