Brief Title: AU-011 (Belzupacap Sarotalocan) in NMIBC

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Safety of AU-011: Incidences of SAEs and DLTs

Primary Outcome 1 - Timeframe: 56 days

CONDITION

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

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: Medical Monitor

Phone: 617-500-8864

Email: [email protected]

LOCATION