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

Phase 1

Recruiting

• Conditions: Non-muscle-invasive Bladder Cancer; Muscle-Invasive Bladder Carcinoma
• Interventions: Combination Product: AU-011 in Combination with Medical Laser Adminstration; Combination Product: AU-011 in Combination with Medical Laser Administration; Drug: AU-011

• Registration Number: NCT05483868
• Lead Sponsor: Aura Biosciences

Brief 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.

Study Timeline

• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-07-29
• Study First Posted: 2022-08-02
• Study Start: 2022-09-26
• Status Verified: 2024-06
• Primary Completion: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-12
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 21

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intratumoral and intramural injection of AU-011 with laser application before TURBT (4a)	AU-011 in Combination with Medical Laser Adminstration	Intratumoral (50 μg) and intramural (50 μg) injection of AU-011 with laser application before standard of care (TURBT) in patients with NMIBC.
Intratumoral injection of AU-011 with laser application before TURBT (4b)	AU-011 in Combination with Medical Laser Administration	Intratumoral injection of AU-011 (100 μg) with laser application before standard of care (TURBT) in patients with NMIBC.
AU-011 intratumoral injection with laser application prior to cystectomy (5a)	AU-011 in Combination with Medical Laser Administration	Intratumoral injection of AU-011 (100 μg) with laser application followed by standard of care (cystectomy) in patients with NMIBC or MIBC.
Intratumoral injection of AU-011 with laser application before TURBT (4c)	AU-011 in Combination with Medical Laser Administration	Intratumoral injection of AU-011 (200 μg) with laser application before standard of care (TURBT) in patients with NMIBC.
AU-011 intratumoral injection with laser application prior to cystectomy (5b)	AU-011 in Combination with Medical Laser Administration	Intratumoral injection of AU-011 (200 μg) with laser application followed by standard of care (cystectomy) in patients with NMIBC or MIBC.
Intratumoral and intramural injection of AU-011 prior to TURBT (1b)	AU-011	Intratumoral (50 μg) and intramural (50 μg) injection of AU-011 prior to the standard of care (TURBT) in patients with NMIBC.

Primary Outcome Measures

Name	Time	Method
Safety of AU-011: Incidences of SAEs and DLTs	56 days	Incidence and severity of treatment-related adverse events and serious adverse events (SAEs) and incidence of dose-limiting toxicities (DLTs).

Trial Locations

Locations (9)

Saint John's Cancer Institute; 🇺🇸 Santa Monica, California, United States

Urology Associates, P.C.; 🇺🇸 Nashville, Tennessee, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

The University of Texas San Antonio; 🇺🇸 San Antonio, Texas, United States

Arkansas Urology; 🇺🇸 Little Rock, Arkansas, United States

Mary Crowley Cancer Research; 🇺🇸 Dallas, Texas, United States

Carolina Urologic Research Center; 🇺🇸 Myrtle Beach, South Carolina, United States

Urology San Antonio/USA Clinical Trials; 🇺🇸 San Antonio, Texas, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States