Brief Title: STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] Phase 1

Primary Outcome 1 - Timeframe: 21 days

Primary Outcome 2 - Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Phase 1

Primary Outcome 2 - Timeframe: Time on trial up to 90 days

Primary Outcome 3 - Measure: Recurrence free survival time (Phase 2a)

Primary Outcome 3 - Timeframe: Through study completion up to 24 months

CONDITION

• Non-muscle-invasive Bladder Cancer

ELIGIBILITY

Inclusion Criteria:
1. Are aged 18 years or older;

- 2. Have a history of pathologically confirmed high-grade Ta or T1 NMIBC without CIS who have completed SOC previously, with recurrent papillary disease seen on cystoscopy, and who are undergoing TURBT without perioperative intravesical chemotherapy;

- 3. Are considered high risk for recurrence;

- 4. Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2;

- 5. Have adequate organ and marrow function as defined below:
* Hemoglobin 9.0 g/dL;

- * Absolute neutrophil count 1.5 × 109/L (1500 per mm3);

- * Platelet count 75 × 109/L (75,000 per mm3);

- * Serum bilirubin 1.5 × institutional upper limit of normal (ULN);

- * AST (serum glutamic-oxaloacetic transaminase)/ALT (serum glutamic-pyruvic transaminase) 2.5 × institutional ULN; and

- * Creatinine CL 60 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine CL: Males: Creatinine CL (mL/min) = Weight (kg) × (140 - Age)/72 × serum creatinine (mg/dL); or Females: Creatinine CL (mL/min) = Weight (kg) × (140 - Age) × 0.85/72 × serum creatinine (mg/dL).
Exclusion Criteria:
1. Have a history of CIS or MIBC;

- 2. Are receiving any other investigational agents;

- 3. Have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to resiquimod (R848), or excipients used in STM-416 including poloxamer 407 and sodium hyaluronate;

- 4. Have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Urinary tract infections are not exclusionary unless they are NCI-CTCAE Grade 3 or higher;

- 5. Are a woman of childbearing potential regardless of contraceptive use; Note: Women of childbearing potential are only to be excluded in Phase 1 and Phase 2a to avoid bias due to the low prevalence of NMIBC in this population. However, they will be included in subsequent Phase 2/3 studies.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Seth Lerner, MD

Role: Principal Investigator

Affiliation: Baylor College of Medicine

Overall Contact

Name: Kayti Aviano

Phone: 781-605-8632

Email: [email protected]

LOCATION