RecruitingPhase 1NCT05483868

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

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


Sponsor

Aura Biosciences

Enrollment

55 participants

Start Date

Sep 26, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called belzupacap sarotalocan (AU-011) for bladder cancer that has not invaded the muscle wall (called non-muscle-invasive bladder cancer, or NMIBC). The drug is activated by laser light during a procedure called a cystoscopy (a camera exam of the bladder), targeting tumors from the inside. **You may be eligible if...** - You have been diagnosed with non-muscle-invasive bladder cancer (NMIBC) confirmed by biopsy - Your cancer type fits one of the study cohorts: intermediate-risk (such as multiple small tumors or a single large low-grade tumor) or high-risk (high-grade or T1 stage) - You may have had prior BCG treatment (a standard bladder cancer therapy) but it didn't work, you couldn't tolerate it, or you haven't had it yet **You may NOT be eligible if...** - Your cancer is BCG-refractory (meaning it kept growing despite a full course of BCG treatment) - Your cancer has invaded the muscle layer of the bladder - You have disease outside the bladder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Urology

Little Rock, Arkansas, United States

Tower Urology

Los Angeles, California, United States

Saint John's Cancer Institute

Santa Monica, California, United States

Montefiore Medical Center

The Bronx, New York, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Urology Associates, P.C.

Nashville, Tennessee, United States

Urology Clinics of North Texas

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

The University of Texas San Antonio

San Antonio, Texas, United States

Urology San Antonio/USA Clinical Trials

San Antonio, Texas, United States

The Urology Place

San Antonio, Texas, United States

Westmead Private Hospital

Westmead, New South Wales, Australia

Austin Health

Heidelberg, Victoria, Australia

Warringal Private Hospital

Heidelberg, Victoria, Australia

Penninsula Private Hospital

Langwarrin, Victoria, Australia

The Royal Melbourne Hospital

Parkville, Victoria, Australia

Hollywood Private Hospital

Nedlands, Western Australia, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05483868


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