A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intratumoral and intramural injection of AU-011 prior to TURBT (1b) |
Intratumoral (50 μg) and intramural (50 μg) injection of AU-011 prior to the standard of care (TURBT) in patients with NMIBC. |
|
|
Experimental Intratumoral and intramural injection of AU-011 with laser application before TURBT (4a) |
Intratumoral (50 μg) and intramural (50 μg) injection of AU-011 with laser application before standard of care (TURBT) in patients with NMIBC. |
|
|
Experimental Intratumoral injection of AU-011 with laser application before TURBT (4b) |
Intratumoral injection of AU-011 (100 μg) with laser application before standard of care (TURBT) in patients with NMIBC. |
|
|
Experimental Intratumoral injection of AU-011 with laser application before TURBT (4c) |
Intratumoral injection of AU-011 (200 μg) with laser application before standard of care (TURBT) in patients with NMIBC. |
|
|
Experimental AU-011 intratumoral injection with laser application prior to cystectomy (5a) |
Intratumoral injection of AU-011 (100 μg) with laser application followed by standard of care (cystectomy) in patients with NMIBC or MIBC. |
|
|
Experimental AU-011 intratumoral injection with laser application prior to cystectomy (5b) |
Intratumoral injection of AU-011 (200 μg) with laser application followed by standard of care (cystectomy) in patients with NMIBC or MIBC. |
|
Recruiting Locations
The University of Texas San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- Aura Biosciences
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.