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

Muscle-Invasive Bladder Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05483868
• Other study ID #: AU-011-102
• Status: Recruiting
• Phase: Phase 1
• Start date: September 26, 2022
• Est. completion date: July 2024

Study information

• Verified date: June 2024
• Source: Aura Biosciences
• Contact: Medical Monitor
• Phone: 617-500-8864
• Email: clinical[@]aurabiosciences.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle-Invasive Bladder Carcinoma
• Non-muscle-invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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

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

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	Mary Crowley Cancer Research	Dallas	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	Arkansas Urology	Little Rock	Arkansas
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Urology Associates, P.C.	Nashville	Tennessee
United States	The University of Texas San Antonio	San Antonio	Texas
United States	Urology San Antonio/USA Clinical Trials	San Antonio	Texas
United States	Saint John's Cancer Institute	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Aura Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of AU-011: Incidences of SAEs and DLTs	Incidence and severity of treatment-related adverse events and serious adverse events (SAEs) and incidence of dose-limiting toxicities (DLTs).	56 days