New bladder cancer drug gets first human test
NCT ID NCT05483868
First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 3 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. The main goal is to see if this approach is safe and feasible. About 55 participants will be enrolled, and researchers will monitor for side effects and early signs of tumor response.
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 medical laser
- What this could lead to
- If successful, this could lead to a new, targeted treatment option for non-muscle-invasive 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, so safety and feasibility are the main goals. The treatment may not work or could cause side effects, and it will take years before any potential benefit is confirmed.
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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Arkansas Urology
Little Rock, Arkansas, 72211, United States
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Austin Health
Heidelberg, Victoria, 3084, Australia
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Baylor College of Medicine
Houston, Texas, 77030, United States
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Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29272, United States
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Colorado Clinical Research
Lakewood, Colorado, 80228, United States
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Hollywood Private Hospital
Nedlands, Western Australia, 6009, Australia
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Montefiore Medical Center
The Bronx, New York, 10461, United States
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Penninsula Private Hospital
Langwarrin, Victoria, 3910, Australia
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Saint John's Cancer Institute
Santa Monica, California, 90404, United States
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The Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
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The University of Texas San Antonio
San Antonio, Texas, 78229, United States
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The Urology Place
San Antonio, Texas, 78240, United States
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Tower Urology
Los Angeles, California, 90048, United States
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UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
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Urology Associates, P.C.
Nashville, Tennessee, 37209, United States
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Urology Clinics of North Texas
Dallas, Texas, 75251, United States
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Urology San Antonio/USA Clinical Trials
San Antonio, Texas, 78229, United States
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Warringal Private Hospital
Heidelberg, Victoria, Australia
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Westmead Private Hospital
Westmead, New South Wales, 2145, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Bag-Like device pull bladder tumors out whole?
- Could a simple blood or urine test spot bladder cancer earlier?
- Can heated chemotherapy beat bladder cancer without surgery?
- Can a Two-Drug bladder wash beat cancer recurrence?
- Bladder cancer surgery: what happens after the bladder is removed?
- AI eye on bladder cancer: could a smart navigation system help surgeons remove tumors more completely?