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Laser-Activated drug targets bladder tumors in early trial

NCT ID NCT05483868

First seen Nov 01, 2025 · Last updated Jun 21, 2026 · Updated 38 times

Summary

This early-stage trial is testing a new drug called belzupacap sarotalocan (AU-011) for people with non-muscle-invasive bladder cancer. The drug is injected directly into the tumor, sometimes with a laser to activate it. The main goal is to see if this approach is safe and feasible. About 55 participants will be enrolled.

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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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Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Arkansas Urology

    TERMINATED

    Little Rock, Arkansas, 72211, United States

  • Austin Health

    RECRUITING

    Heidelberg, Victoria, 3084, Australia

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

    Contact Email: •••••@•••••

  • Carolina Urologic Research Center

    RECRUITING

    Myrtle Beach, South Carolina, 29272, United States

    Contact Email: •••••@•••••

  • Hollywood Private Hospital

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10461, United States

    Contact Email: •••••@•••••

  • Penninsula Private Hospital

    NOT_YET_RECRUITING

    Langwarrin, Victoria, 3910, Australia

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Saint John's Cancer Institute

    RECRUITING

    Santa Monica, California, 90404, United States

    Contact Email: •••••@•••••

  • The Royal Melbourne Hospital

    NOT_YET_RECRUITING

    Parkville, Victoria, 3050, Australia

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • The University of Texas San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

    Contact Email: •••••@•••••

  • The Urology Place

    RECRUITING

    San Antonio, Texas, 78240, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Tower Urology

    RECRUITING

    Los Angeles, California, 90048, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Urology Associates, P.C.

    SUSPENDED

    Nashville, Tennessee, 37209, United States

  • Urology Clinics of North Texas

    RECRUITING

    Dallas, Texas, 75251, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Urology San Antonio/USA Clinical Trials

    RECRUITING

    San Antonio, Texas, 78229, United States

    Contact Email: •••••@•••••

  • Warringal Private Hospital

    RECRUITING

    Heidelberg, Victoria, Australia

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Westmead Private Hospital

    RECRUITING

    Westmead, New South Wales, 2145, Australia

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

What this could mean

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

Active substance

belzupacap sarotalocan (AU-011) with or without laser activation

What this could lead to

If successful, this could point toward a new, targeted treatment for early-stage bladder cancer that may reduce the need for more invasive procedures.

What could go wrong

This is a very early Phase 1 trial with only 55 participants, focused on safety and feasibility. It is too soon to know if the treatment will be effective, and there may be side effects from the drug or laser.

Conditions

The condition(s) this trial relates to.

bladder transitional cell carcinoma non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms Urinary Bladder Neoplasms urothelial carcinoma

As listed by the trial registrant

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