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

Description

The main objectives of this study are to determine the feasibility and safety of AU-011 treatment of bladder cancer utilizing intratumoral injection with or without intramural injection and with or without laser application.

Conditions

Non-muscle-invasive Bladder Cancer, Muscle-Invasive Bladder Carcinoma

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Study Overview

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Study Details

Study overview

The main objectives of this study are to determine the feasibility and safety of AU-011 treatment of bladder cancer utilizing intratumoral injection with or without intramural injection and with or without laser application.

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

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

Condition
Non-muscle-invasive Bladder Cancer
Intervention / Treatment

-

Contacts and Locations

Little Rock

Arkansas Urology, Little Rock, Arkansas, United States, 72211

Santa Monica

Saint John's Cancer Institute, Santa Monica, California, United States, 90404

Bronx

Montefiore Medical Center, Bronx, New York, United States, 10461

Myrtle Beach

Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States, 29272

Nashville

Urology Associates, P.C., Nashville, Tennessee, United States, 37209

Dallas

Mary Crowley Cancer Research, Dallas, Texas, United States, 75251

Houston

Baylor College of Medicine, Houston, Texas, United States, 77030

San Antonio

The University of Texas San Antonio, San Antonio, Texas, United States, 78229

San Antonio

Urology San Antonio/USA Clinical Trials, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Confirmed diagnosis urothelial carcinoma of the bladder (Recurrence of prior NMIBC biopsy or pathology must be obtained within 12 months prior to enrollment. First time NMIBC biopsy within 6 months of screening. MIBC allowed if demonstrated pathologically)
  • 2. Have no evidence of metastatic disease
  • 3. Adequate bone marrow, renal, and hepatic function
  • 1. Any additional malignancy that requires active treatment. Exceptions include:
  • 1. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy with evidence of remission for at least 1 year.
  • 2. In situ cervical cancer treated and with at least 1 year without recurrence.
  • 3. Any other subject felt appropriate by the Investigator upon discussion with 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. Chronic active hepatitis B or C and HIV.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Aura Biosciences,

Study Record Dates

2024-07