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: up to 12 months

CONDITION

• Non-muscle-invasive Bladder Cancer
• NMIBC
• Non-Muscle Invasive Bladder Carcinoma
• Non-Muscle Invasive Bladder Neoplasms
• Non-Muscle Invasive Bladder Urothelial Carcinoma
• Urothelial Carcinoma Bladder

ELIGIBILITY

Inclusion Criteria:
1. Meet the following histopathologic requirements for urothelial carcinoma:
* For Cohorts 1b, 4a-c:
histopathological diagnosis of NMIBC (any grade) is required. For participants with first diagnosis of NMIBC, confirmation of urothelial carcinoma by recent biopsy (≤6 months of Screening Visit) is required. Participants with recurrent NMIBC must have a current lesion that clinically appears to be NMIBC with histopathologic confirmation based on TURBT or biopsy within the last 24 months).
For Cohorts 4d, 4e, 4g and 4h, a diagnosis of LG IR NMIBC (according to
AUA risk classification guidelines) is required, specifically:

- * Multifocal LG Ta; OR

- * Solitary LG Ta >3 cm; OR

- * Low-grade Ta with prior recurrence(s) within 1 year.
For Cohorts 4f and 4i, a diagnosis of HR NMIBC (according to AUA risk classification guidelines) is required, specifically:

- * Ta HG papillary disease with or without CIS; OR

- * T1 papillary disease with or without CIS

- * Participants may be BCG-naïve or may have received prior treatment with BCG for HR or IR NMIBC (BCG-exposed, BCG-failed, BCG-intolerant)

- * BCG-refractory participants are excluded. BCG-refractory is defined by the following:
* Persistent HG disease at 6 months following adequate BCG (defined as ≥5/6 induction instillations and ≥2 additional doses, either from re-induction or maintenance), OR

- * HG T1 disease at first evaluation (3 months) after BCG, OR

- * Persistent CIS that remains despite a second BCG course, OR

- * Disease progression in stage or grade during BCG therapy, including maintenance

- 2. Have no evidence of current or prior metastatic urothelial carcinoma

- 3. Adequate bone marrow, renal, and hepatic function
Exclusion Criteria:
1. Any additional malignancy that requires active treatment, unless deemed appropriate after discussion by the Investigator with the 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. Active autoimmune disease, chronic inflammatory condition, or other conditions (like solid organ transplant or bone marrow allograft) requiring concurrent use of any systemic immunosuppressants or steroids.

- 5. Chronic active hepatitis B or C and HIV.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Medical Monitor

Role: Study Director

Affiliation: Aura Biosciences

Overall Contact

Name: Medical Monitor

Phone: 617-500-8864

Email: [email protected]

LOCATION