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RecruitingInterventionalPhase 1

A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) to Determine the Feasibility and Safety of Intratumoral Injection With or Without Intramural Injection in Subjects With Bladder Cancer

NCT ID: NCT05483868Sponsor: Aura BiosciencesLast updated: 2026-04-15

Summary

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.

Detailed description

Aura is enrolling participants with urothelial carcinoma to evaluate the safety, technical feasibility, and preliminary efficacy of bel-sar. The goal is to achieve the trial objectives with minimal disruption to the standard of care (SoC) of the treating Investigator.

Arms & interventions

  • DrugAU-011

    Administration of AU-011 intratumorally and intramurally

  • Combination ProductAU-011 in Combination with Medical Laser Adminstration

    AU-011 Intratumorally and Intramurally

  • Combination ProductAU-011 in Combination with Medical Laser Administration

    AU-011 Intratumorally

Outcome measures

Primary

  • Safety of AU-011: Incidences of SAEs and DLTs

    Incidence and severity of treatment-related adverse events \[time frame 12 months\], serious adverse events \[time frame 12 months\], and incidence of dose-limiting toxicities \[time frame 14 days\]

    Time frame: up to 12 months

Secondary

  • Complete response (CR) rate

    Time frame: at the 3-month time point and at TURBT

  • Duration of response (DoR)

    Time frame: 12 months

  • Durable CR rate

    Time frame: 6-, 9-, and 12-month follow-up

  • Recurrence-free survival (RFS)

    Time frame: 12 mos

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (11)

Arkansas Urology

Little Rock, Arkansas, 72211

Terminated

Tower Urology

Los Angeles, California, 90048

Recruiting
David Josephson · Principal Investigator

Saint John's Cancer Institute

Santa Monica, California, 90404

Recruiting
Frances Feng · Contact

Montefiore Medical Center

The Bronx, New York, 10461

Recruiting
Jerel Johnson · Contact

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29272

Recruiting
Jessica Richardson · Contact

Urology Associates, P.C.

Nashville, Tennessee, 37209

Suspended

Urology Clinics of North Texas

Dallas, Texas, 75251

Recruiting

Baylor College of Medicine

Houston, Texas, 77030

Recruiting
Sharon Harrison · Contact

The University of Texas San Antonio

San Antonio, Texas, 78229

Recruiting
Ahmad Abdel-Aziz · Contact

Urology San Antonio/USA Clinical Trials

San Antonio, Texas, 78229

Recruiting
Stefanie Galvin · Contact

The Urology Place

San Antonio, Texas, 78240

Recruiting
Olivia Soto · Contact
A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer | Cancerify