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
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
Study locations (11)
Arkansas Urology
Little Rock, Arkansas, 72211
Tower Urology
Los Angeles, California, 90048
Saint John's Cancer Institute
Santa Monica, California, 90404
Montefiore Medical Center
The Bronx, New York, 10461
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29272
Urology Associates, P.C.
Nashville, Tennessee, 37209
Urology Clinics of North Texas
Dallas, Texas, 75251
Baylor College of Medicine
Houston, Texas, 77030
The University of Texas San Antonio
San Antonio, Texas, 78229
Urology San Antonio/USA Clinical Trials
San Antonio, Texas, 78229
The Urology Place
San Antonio, Texas, 78240