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

Aura Biosciences

Status and phase: Enrolling; Phase 1

Conditions: Non-muscle-invasive Bladder Cancer; Muscle-Invasive Bladder Carcinoma

Treatments: Combination Product: AU-011 in Combination with Medical Laser Adminstration; Combination Product: AU-011 in Combination with Medical Laser Administration; Drug: AU-011

Study type: Interventional

Funder types: Industry

Identifiers

NCT05483868

AU-011-102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 6 patient groups

Intratumoral and intramural injection of AU-011 prior to TURBT (1b)

Experimental group

Description:

Intratumoral (50 μg) and intramural (50 μg) injection of AU-011 prior to the standard of care (TURBT) in patients with NMIBC.

Treatment:

Drug: AU-011

Intratumoral and intramural injection of AU-011 with laser application before TURBT (4a)

Experimental group

Description:

Intratumoral (50 μg) and intramural (50 μg) injection of AU-011 with laser application before standard of care (TURBT) in patients with NMIBC.

Treatment:

Combination Product: AU-011 in Combination with Medical Laser Adminstration

Intratumoral injection of AU-011 with laser application before TURBT (4b)

Experimental group

Description:

Intratumoral injection of AU-011 (100 μg) with laser application before standard of care (TURBT) in patients with NMIBC.

Treatment:

Combination Product: AU-011 in Combination with Medical Laser Administration

Intratumoral injection of AU-011 with laser application before TURBT (4c)

Experimental group

Description:

Intratumoral injection of AU-011 (200 μg) with laser application before standard of care (TURBT) in patients with NMIBC.

Treatment:

Combination Product: AU-011 in Combination with Medical Laser Administration

AU-011 intratumoral injection with laser application prior to cystectomy (5a)

Experimental group

Description:

Intratumoral injection of AU-011 (100 μg) with laser application followed by standard of care (cystectomy) in patients with NMIBC or MIBC.

Treatment:

Combination Product: AU-011 in Combination with Medical Laser Administration

AU-011 intratumoral injection with laser application prior to cystectomy (5b)

Experimental group

Description:

Intratumoral injection of AU-011 (200 μg) with laser application followed by standard of care (cystectomy) in patients with NMIBC or MIBC.

Treatment:

Combination Product: AU-011 in Combination with Medical Laser Administration