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.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 55 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2022
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Meet the following histopathologic requirements for urothelial carcinoma: * For Cohorts 1b, 4a-c: histopathological diagnosis of NMIBC (any grade) is required. For participants with first diagnosis of NMIBC, confirmation of urothelial carcinoma by recent biopsy (≤6 months of Screening Visit) is required. Participants with recurrent NMIBC must have a current lesion that clinically appears to be NMIBC with histopathologic confirmation based on TURBT or biopsy within the last 24 months). For Cohorts 4d, 4e, 4g and 4h, a diagnosis of LG IR NMIBC (according to AUA risk classification guidelines) is required, specifically: * Multifocal LG Ta; OR * Solitary LG Ta \>3 cm; OR * Low-grade Ta with prior recurrence(s) within 1 year. For Cohorts 4f and 4i, a diagnosis of HR NMIBC (according to AUA risk classification guidelines) is required, specifically: * Ta HG papillary disease with or without CIS; OR * T1 papillary disease with or without CIS * Participants may be BCG-naïve or may have received prior treatment with BCG for HR or IR NMIBC (BCG-exposed, BCG-failed, BCG-intolerant) * BCG-refractory participants are excluded. BCG-refractory is defined by the following: * Persistent HG disease at 6 months following adequate BCG (defined as ≥5/6 induction instillations and ≥2 additional doses, either from re-induction or maintenance), OR * HG T1 disease at first evaluation (3 months) after BCG, OR * Persistent CIS that remains despite a second BCG course, OR * Disease progression in stage or grade during BCG therapy, including maintenance 2. Have no evidence of current or prior metastatic urothelial carcinoma 3. Adequate bone marrow, renal, and hepatic function Exclusion Criteria: 1. Any additional malignancy that requires active treatment, unless deemed appropriate after discussion by the Investigator with the trial's Medical Monitor. 2. Used an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) of Visit 1 or be concurrently enrolled in another investigational trial. 3. Active bacterial, fungal, or viral infections - all prior infections must have resolved following optimal therapy and subject must be off all systemic anti-infective agents. 4. Active autoimmune disease, chronic inflammatory condition, or other conditions (like solid organ transplant or bone marrow allograft) requiring concurrent use of any systemic immunosuppressants or steroids. 5. Chronic active hepatitis B or C and HIV.
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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.
- Lab-Grown tumor organoids could pick the right bladder chemo
- Can heated saline during bladder surgery stop tumors from coming back?
- Radiation instead of bladder removal: a new option for Hard-to-Treat bladder cancer?
- Can an immunotherapy plus chemotherapy keep High-Risk bladder cancer at bay?
- Can a bladder rinse before surgery keep bladder cancer at bay?
- Timing chemotherapy around bladder surgery may cut recurrence