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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Administration of AU-011 intratumorally and intramurally
AU-011 Intratumorally and Intramurally
AU-011 Intratumorally
Arkansas Urology
Little Rock, Arkansas, United States
TERMINATEDTower Urology
Los Angeles, California, United States
RECRUITINGSaint John's Cancer Institute
Santa Monica, California, United States
RECRUITINGMontefiore Medical Center
The Bronx, New York, United States
RECRUITINGCarolina Urologic Research Center
Myrtle Beach, South Carolina, United States
RECRUITINGUrology Associates, P.C.
Nashville, Tennessee, United States
SUSPENDEDUrology Clinics of North Texas
Dallas, Texas, United States
RECRUITINGBaylor College of Medicine
Houston, Texas, United States
RECRUITINGThe University of Texas San Antonio
San Antonio, Texas, United States
RECRUITINGUrology San Antonio/USA Clinical Trials
San Antonio, Texas, United States
RECRUITING...and 7 more locations
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
Complete response (CR) rate
for all cohorts
Time frame: at the 3-month time point and at TURBT
Duration of response (DoR)
In participants who achieve CR
Time frame: 12 months
Durable CR rate
Proportion of participants maintaining a CR after achieving a CR
Time frame: 6-, 9-, and 12-month follow-up
Recurrence-free survival (RFS)
Participants in neoadjuvant cohorts
Time frame: 12 mos
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