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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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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

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