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New bladder cancer drug shows early promise in small trial

NCT ID NCT05375903

Completed Disease control Sponsor: UroGen Pharma Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested a new drug called UGN-301 (zalifrelimab) given directly into the bladder for people with recurrent non-muscle invasive bladder cancer. The study included 51 participants and aimed to check safety and find the right dose, both alone and with other drugs. Results will help decide if larger studies should move forward.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

UGN-301 (zalifrelimab) and UGN-201 (imiquimod) given directly into the bladder

What this could lead to

If successful, this could lead to a new treatment option for people with recurrent bladder cancer that hasn't responded to standard therapy.

What could go wrong

This is a very early (Phase 1) trial with only 51 participants, so safety and dosing are still being figured out. It may not work or could have side effects.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

bladder carcinoma in situ bladder transitional cell carcinoma non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms superficial urinary bladder carcinoma urinary bladder carcinoma Urinary Bladder Neoplasms urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BLADDER CANCER CARCINOMA IN SITU OF BLADDER NMIBC NON MUSCLE INVASIVE BLADDER CANCER UROTHELIAL CARCINOMA BLADDER UROTHELIAL CARCINOMA RECURRENT

Contacts and locations

Locations

  • Arkansas Urology

    Little Rock, Arkansas, 72211, United States

  • Clinical Research Solutions

    Middleburg Heights, Ohio, 44130, United States

  • Florida Urology Partners, LLC

    Tampa, Florida, 33615, United States

  • Hospital Clinic de Barcelona Instituto Clinic de Nefrologia y Urologia (ICNU)

    Barcelona, 08036, Spain

  • I.R.C.C.S. Ospedale San Raffaele

    Milan, Italy

  • Istituto Oncologico Veneto

    Padova, Italy

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • Manhattan Medical Research

    New York, New York, 10016, United States

  • NEXT Oncology IOB- Hospital Quironsalud Barcelona

    Barcelona, 08023, Spain

  • NEXT Oncology- Hospital Quironsalud Mardrid

    Madrid, 28223, Spain

  • National Tumor Institute Fondazione G. Pascale

    Naples, Italy

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • UCLA - University of California

    Los Angeles, California, 90095, United States