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

A Phase 1/2a Study of STM-416 Administered Intraoperatively to Patients Undergoing Transurethral Resection of Bladder Tumor (TURBT) for Recurrent High-Grade Papillary Bladder Cancer

INTRODUCTION

  • Org Study ID: STM-416-01
  • Secondary ID: N/A
  • NCT ID: NCT05710848
  • Sponsor: SURGE Therapeutics

DESCRIPTION

You may be able to take part in this research study if you have a specific type of cancer known as non-muscle invasive bladder cancer (NMIBC) without carcinoma-in-situ (CIS) with recurrent papillary disease and you are about to undergo a surgery for this condition known as transurethral resection of bladder tumor (TURBT). TURBT is a surgical procedure that provides a look inside the bladder to help confirm or rule out cancer. If a cancer is found then your doctor may be able to remove part, all, or almost all of the tumor during the procedure. TURBT is sometimes followed by intravesical therapy, the direct application of treatment into the bladder in an attempt to kill any remaining cancer cells. For example, Bacillus Calmette-Guerin (BCG) is a common type of intravesical immunotherapy that activates your own immune system to attack bladder cancer cells. Bladder cancer can, however, recur after TURBT, sometimes more than once. The likelihood of recurrence depends on many factors. One of them is how effective your own immune system is able to eliminate cancer cells that remain after the TURBT. This study is investigating a new kind of immunotherapy called STM-416, which can be applied to your bladder during the TURBT procedure to deliver the therapy locally and thereby help your immune system to fight and eliminate any cancer cells that might remain.

The active ingredient of STM-416 has already been used in other clinical trials to treat other kinds of cancer. STM-416 employs a new formulation (mix of ingredients) that allows its application during TURBT at the site and time of surgery. The main purpose of the current study is to learn whether STM-416 is safe and can be tolerated by patients with NMIBC undergoing TURBT. The research procedures include patient screening, TURBT with injection of STM-416 into the bladder muscle, and a 90-day period of monitoring for any symptoms.

BRIEF SUMMARY

This is a first-in-human (FIH), Phase 1/2a, multi center, open-label, single treatment, dose escalation and expansion study designed to determine the safety and tolerability of STM-416 in patients with bladder cancer.

DETAILED DESCRIPTION

This is a 2-part, multicenter, first-in-human (FIH), Phase 1/2a study in patients with 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. All patients will receive relevant SOC therapy following TURBT. SOC will be administered in the adjuvant setting.

Phase 1 is an open-label, single-treatment, dose-escalation study to evaluate the safety and tolerability of up to 4 increasing doses of intraoperatively administered STM-416 utilizing a 3+3 convention, with 3 to 6 patients enrolled in each STM-416 dose level, with a minimum of 6 patients enrolled at the highest dose level, for a total of approximately 24 patients.

Phase 2a is a randomized, single-blind, single-treatment, dose-expansion study that will comprise 2 arms: TURBT + STM-416 Dose 1 followed by SOC versus TURBT + STM-416 Dose 2 followed by SOC.

  • Overall Status
    Recruiting
  • Start Date
    July 11, 2023
  • Phase
    PHASE1, PHASE2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

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: kayti@surgetx.com

LOCATION

Facility Status Contact
Facility: Arizona Urology Specialists
Tucson, Arizona 85715
United States
Status: Recruiting Contact: Contact
Christina Montijo
cmontijo@arizonauro.com

Principal Investigator
Susan Kalota, MD

Facility: University of Florida
Gainesville, Florida 32608
United States
Status: Recruiting Contact: Contact
Casey Walsh
CaseyWalsh@cancer.ufl.edu

Principal Investigator
Padraic O'Malley, MD

Facility: Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Status: Recruiting Contact: Principal Investigator
Boris Gershman, MD

Facility: Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Status: Recruiting Contact: Contact
Jessica Richardson
Jrichardson@curcmb.com

Principal Investigator
Abhishek Srivastava, MD

Facility: Urology Associates, P.C.
Nashville, Tennessee 37209
United States
Status: Recruiting Contact: Contact
Joe Wallace
jawallace@ua-pc.com

Principal Investigator
Gautam Jayram, MD

Facility: University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
Status: Recruiting Contact: Contact
Jose Santoyo
Jose.Santoyo@UTSouthwestern.edu

Principal Investigator
Yair Lotan, M.D.

Facility: Baylor College of Medicine
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Sharon Harrison
sharons@bcm.edu

Principal Investigator
Seth Paul Lerner, M.D.