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

NCT ID: NCT05483868

Condition: Non-muscle-invasive Bladder Cancer
Muscle-Invasive Bladder Carcinoma

Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms

Conditions: Keywords:
NMIBC
Cystectomy
TURBT
Intramural
AU-011
Belzupacap Sarotalocan
Intratumoral
MIBC

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: AU-011
Description: Administration of AU-011 intratumorally and intramurally
Arm group label: Intratumoral and intramural injection of AU-011 prior to TURBT (1b)

Intervention type: Combination Product
Intervention name: AU-011 in Combination with Medical Laser Adminstration
Description: AU-011 Intratumorally and Intramurally
Arm group label: Intratumoral and intramural injection of AU-011 with laser application before TURBT (4a)

Intervention type: Combination Product
Intervention name: AU-011 in Combination with Medical Laser Administration
Description: AU-011 Intratumorally
Arm group label: AU-011 intratumoral injection with laser application prior to cystectomy (5a)
Arm group label: AU-011 intratumoral injection with laser application prior to cystectomy (5b)
Arm group label: Intratumoral injection of AU-011 with laser application before TURBT (4b)
Arm group label: Intratumoral injection of AU-011 with laser application before TURBT (4c)

Summary: 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.

Detailed description: Aura is conducting a Phase 1, 'window of opportunity', open-label trial of belzupacap sarotalocan (AU-011) to determine the feasibility and safety of intratumoral injection with or without intramural injection and with or without laser application in subjects with bladder cancer.

Criteria for eligibility:
Criteria:
Inclusion 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 Exclusion Criteria: 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Arkansas Urology

Address:
City: Little Rock
Zip: 72211
Country: United States

Status: Terminated

Facility:
Name: Saint John's Cancer Institute

Address:
City: Santa Monica
Zip: 90404
Country: United States

Status: Recruiting

Contact:
Last name: Frances Feng
Email: mailto:frances.feng@providence.org

Facility:
Name: Montefiore Medical Center

Address:
City: Bronx
Zip: 10461
Country: United States

Status: Recruiting

Contact:
Last name: Jerel Johnson
Email: jerjohnson@montefiore.org

Facility:
Name: Carolina Urologic Research Center

Address:
City: Myrtle Beach
Zip: 29272
Country: United States

Status: Recruiting

Contact:
Last name: Jennifer Sutton
Email: jsutton@curcmb.com

Facility:
Name: Urology Associates, P.C.

Address:
City: Nashville
Zip: 37209
Country: United States

Status: Recruiting

Contact:
Last name: Mercedes Bruce
Email: MBruce@ua-pc.com

Facility:
Name: Mary Crowley Cancer Research

Address:
City: Dallas
Zip: 75251
Country: United States

Status: Recruiting

Contact:
Last name: Joshua Matson

Phone: 214-658-1987
Email: jomatson@marycrowley.org

Facility:
Name: Baylor College of Medicine

Address:
City: Houston
Zip: 77030
Country: United States

Status: Recruiting

Contact:
Last name: Sharon Harrison
Email: sharons@bcm.edu

Facility:
Name: The University of Texas San Antonio

Address:
City: San Antonio
Zip: 78229
Country: United States

Status: Recruiting

Contact:
Last name: Ahmad Abdel-Aziz
Email: Abdelaziza1@uthscsa.edu

Facility:
Name: Urology San Antonio/USA Clinical Trials

Address:
City: San Antonio
Zip: 78229
Country: United States

Status: Recruiting

Contact:
Last name: Karina Lozano
Email: karina.lozano@usa-clinicaltrials.com

Contact backup:
Last name: Jose

Start date: September 26, 2022

Completion date: July 2024

Lead sponsor:
Agency: Aura Biosciences
Agency class: Industry

Source: Aura Biosciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05483868

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