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OncoMatch/Clinical Trials/NCT05483868

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

Is NCT05483868 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including AU-011 and AU-011 in Combination with Medical Laser Adminstration for non-muscle-invasive bladder cancer.

Phase 1RecruitingAura BiosciencesNCT05483868Data as of May 2026

Treatment: AU-011 · AU-011 in Combination with Medical Laser Adminstration · AU-011 in Combination with Medical Laser Administration — 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.

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Extracted eligibility criteria

Cancer type

Urothelial Carcinoma

Disease stage

Required: Stage CIS (AUA risk classification guidelines)

Excluded: Stage MUSCLE-INVASIVE

Grade: low-gradehigh-grade (AUA risk classification guidelines)

diagnosis of LG IR NMIBC ... Multifocal LG Ta; OR Solitary LG Ta >3 cm; OR Low-grade Ta with prior recurrence(s) within 1 year. ... diagnosis of HR NMIBC ... Ta HG papillary disease with or without CIS; OR T1 papillary disease with or without CIS

Prior therapy

Cannot have received: BCG

Exception: BCG-refractory participants are excluded

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

Lab requirements

Blood counts

Kidney function

Liver function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Arkansas Urology · Little Rock, Arkansas
  • Tower Urology · Los Angeles, California
  • Saint John's Cancer Institute · Santa Monica, California
  • Montefiore Medical Center · The Bronx, New York
  • Carolina Urologic Research Center · Myrtle Beach, South Carolina

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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