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NCT05483868PHASE1Recruiting

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

Aura Biosciences

Start Date

9/26/2022

Completion Date

3/1/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

AU-011

COMBINATION_PRODUCT

AU-011 in Combination with Medical Laser Adminstration

COMBINATION_PRODUCT

AU-011 in Combination with Medical Laser Administration

Interested in This Trial?

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Conditions

Non-muscle-invasive Bladder CancerNMIBCNon-Muscle Invasive Bladder CarcinomaNon-Muscle Invasive Bladder NeoplasmsNon-Muscle Invasive Bladder Urothelial CarcinomaUrothelial Carcinoma Bladder

Locations

Arkansas Urology

Little Rock, Arkansas 72211

United States

Tower Urology

Los Angeles, California 90048

United States

Saint John's Cancer Institute

Santa Monica, California 90404

United States

Montefiore Medical Center

The Bronx, New York 10461

United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina 29272

United States

Urology Associates, P.C.

Nashville, Tennessee 37209

United States

Urology Clinics of North Texas

Dallas, Texas 75251

United States

Baylor College of Medicine

Houston, Texas 77030

United States

The University of Texas San Antonio

San Antonio, Texas 78229

United States

Urology San Antonio/USA Clinical Trials

San Antonio, Texas 78229

United States

The Urology Place

San Antonio, Texas 78240

United States

Westmead Private Hospital

Westmead, New South Wales 2145

Australia

Austin Health

Heidelberg, Victoria 3084

Australia

Warringal Private Hospital

Heidelberg, Victoria

Australia

Penninsula Private Hospital

Langwarrin, Victoria 3910

Australia

The Royal Melbourne Hospital

Parkville, Victoria 3050

Australia

Hollywood Private Hospital

Nedlands, Western Australia 6009

Australia