🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT05483868
Active, not recruiting Phase 1

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

NCT05483868 · tracked via the Priya Life Science USA tracker
Sponsor
Aura Biosciences
Phase
Phase 1
Started
2022-09-26
Last updated
2026-08-06

Condition(s) studied

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

Investigational drug(s) / intervention(s)

AU-011AU-011 in Combination with Medical Laser AdminstrationAU-011 in Combination with Medical Laser Administration

AU-011: Administration of AU-011 intratumorally and intramurally

AU-011 in Combination with Medical Laser Adminstration: AU-011 Intratumorally and Intramurally

AU-011 in Combination with Medical Laser Administration: AU-011 Intratumorally

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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 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.

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
Arkansas Urology Little Rock Arkansas
Tower Urology Los Angeles California
Saint John's Cancer Institute Santa Monica California
Colorado Clinical Research Lakewood Colorado
Montefiore Medical Center The Bronx New York
UPMC Hillman Cancer Center Pittsburgh Pennsylvania
Carolina Urologic Research Center Myrtle Beach South Carolina
Urology Associates, P.C. Nashville Tennessee
Urology Clinics of North Texas Dallas Texas
Baylor College of Medicine Houston Texas
The University of Texas San Antonio San Antonio Texas
Urology San Antonio/USA Clinical Trials San Antonio Texas
The Urology Place San Antonio Texas
Westmead Private Hospital Westmead New South Wales
Austin Health Heidelberg Victoria
Warringal Private Hospital Heidelberg Victoria
Penninsula Private Hospital Langwarrin Victoria
The Royal Melbourne Hospital Parkville Victoria
Hollywood Private Hospital Nedlands Western Australia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05483868 on ClinicalTrials.gov ↗ ← All trials in the USA