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

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objectives of this study are i) to evaluate the incidence of AU-011 treatment-related adverse events, serious adverse events (SAEs) and dose-limiting toxicities (DLTs) and ii) to determine the feasibility of AU-011 treatment of non-muscle invasive bladder cancer utilizing intramural with or without intratumoral injection.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aura Biosciences

Criteria

Inclusion Criteria:

1. Have NMIBC with urothelial carcinoma confirmed by histopathology (note: if recurrent lesion, previous tumor biopsy is acceptable). Biopsy or pathology must be obtained within 6 months prior to screening

2. Have no evidence of metastatic disease

3. Have a normal upper urinary tract

4. Adequate bone marrow, renal, and hepatic function

Exclusion Criteria:

1. Current or history of muscle invasive (i.e., T2 or higher) bladder cancer per AUA guideline or metastatic urothelial carcinoma.

2. Any additional malignancy that requires 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. Localized prostate cancer under active care that was treated with definitive therapy (surgically or through radiation therapy) is acceptable, provided that the following criteria are met:

• Stage T2N0M0 or lower; prostate-specific antigen (PSA) undetectable for 2 years while off androgen deprivation therapy or no more than 2 consecutive rising PSAs.

• Tumors can be low or intermediate risk prostate cancer under active surveillance.

• Any significant illness or clinically significant laboratory abnormalities that the Investigator determines could interfere with trial participation or put the subject at any unnecessary risk.

3. 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.

4. 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.

5. Chronic active hepatitis B or C.