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
Aura Biosciences
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.
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
- Age range
- 18+ years
- Sex
- All
- Healthy 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…
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
Locations (17)
- Arkansas UrologyLittle Rock, Arkansas
- Tower UrologyLos Angeles, California
- Saint John's Cancer InstituteSanta Monica, California
- Montefiore Medical CenterThe Bronx, New York
- Carolina Urologic Research CenterMyrtle Beach, South Carolina
- Urology Associates, P.C.Nashville, Tennessee