A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer

Running, not enrolling · Phase 1

Conditions studied: Non-muscle-invasive Bladder Cancer, NMIBC, Non-Muscle Invasive Bladder Carcinoma, Non-Muscle Invasive Bladder Neoplasms, Non-Muscle Invasive Bladder Urothelial Carcinoma, Urothelial Carcinoma Bladder

In brief

The main objectives of this study are to determine the feasibility and safety of Belzupacap Sarotalocan (AU-011, bel-sar) treatment of bladder cancer utilizing focal injections with or without laser application.

Key facts

Study ID

NCT05483868

Run by

Aura Biosciences

People needed

55

Starts

2022-09-26

Expected to finish

2027-03-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Have no evidence of current or prior metastatic urothelial carcinoma
• Adequate bone marrow, renal, and hepatic function

You may not qualify if…

• Any additional malignancy that requires active treatment, unless deemed appropriate after discussion by the Investigator with the trial's Medical Monitor.
• 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.
• 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.
• 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.
• Chronic active hepatitis B or C and HIV.

Where it is running

• Arkansas Urology — Little Rock, Arkansas, United States
• Tower Urology — Los Angeles, California, United States
• Saint John's Cancer Institute — Santa Monica, California, United States
• Colorado Clinical Research — Lakewood, Colorado, United States
• Montefiore Medical Center — The Bronx, New York, United States
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Urology Associates, P.C. — Nashville, Tennessee, United States
• Urology Clinics of North Texas — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• The University of Texas San Antonio — San Antonio, Texas, United States
• Urology San Antonio/USA Clinical Trials — San Antonio, Texas, United States
• The Urology Place — San Antonio, Texas, United States
• Westmead Private Hospital — Westmead, New South Wales, Australia
• Austin Health — Heidelberg, Victoria, Australia
• Warringal Private Hospital — Heidelberg, Victoria, Australia
• Penninsula Private Hospital — Langwarrin, Victoria, Australia
• The Royal Melbourne Hospital — Parkville, Victoria, Australia
• Hollywood Private Hospital — Nedlands, Western Australia, Australia

Full record on ClinicalTrials.gov

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