Treatment for recurrent bladder cancer using STM-416

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

This study is testing a new treatment called STM-416 for people with recurrent bladder cancer to see if it's safe and how well it works compared to standard care.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: SURGE Therapeutics (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 10 sites (Tucson, Arizona and 9 other locations)
• Trial ID: NCT05710848 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, Phase 1/2a, multicenter, open-label study designed to evaluate the safety and tolerability of STM-416 in patients with recurrent non-muscle-invasive bladder cancer (NMIBC) undergoing transurethral resection of bladder tumor (TURBT). The study consists of two phases: Phase 1 focuses on dose escalation to determine the maximum tolerated dose of STM-416, while Phase 2a involves a randomized comparison of two different doses of STM-416 followed by standard of care therapy. Patients will be monitored for safety and efficacy throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a history of high-grade Ta or T1 NMIBC who are at high risk for recurrence and are undergoing TURBT without prior intravesical chemotherapy.

Not a fit: Patients with muscle-invasive bladder cancer or those who have not completed standard of care therapy prior to TURBT may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with recurrent bladder cancer, potentially improving outcomes and reducing recurrence rates.

How similar studies have performed: While this approach is novel in its specific application, similar studies targeting NMIBC with immunotherapy have shown promising results.

Eligibility criteria

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.

Where this trial is running

Tucson, Arizona and 9 other locations

• Arizona Urology Specialists — Tucson, Arizona, United States (Recruiting)
• University of Florida — Gainesville, Florida, United States (Recruiting)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
• Duke Cancer Center — Durham, North Carolina, United States (Recruiting)
• The Ohio State University — Columbus, Ohio, United States (Recruiting)
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States (Recruiting)
• Urology Associates, P.C. — Nashville, Tennessee, United States (Recruiting)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
• Baylor College of Medicine — Houston, Texas, United States (Recruiting)
• Houston Methodist — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Seth Lerner, MD — Baylor College of Medicine
• Study coordinator: Kayti Aviano

Conditions Non-muscle-invasive Bladder Cancer; Open-label; Dose escalation; STM-416; Resiquimod; Toll-like receptor 7/8; Non-Muscle Invasive Bladder Cancer; TURBT