Overview

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.

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.