A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer

Recruiting now · Phase 1/Phase 2

Conditions studied: Non-muscle-invasive Bladder Cancer

In brief

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.

Key facts

Study ID

NCT05710848

Run by

SURGE Therapeutics

People needed

75

Starts

2023-07-11

Expected to finish

2026-08-01

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Are aged 18 years or older;
• 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;
• Are considered high risk for recurrence;
• Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2;
• 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).

You may not qualify if…

• Have a history of CIS or MIBC;
• Are receiving any other investigational agents;
• 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;
• 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;
• 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 it is running

• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (enrolling)
• East Valley Urology Center of Arizona — Mesa, Arizona, United States (enrolling)
• Arkansas Urology — Little Rock, Arkansas, United States (enrolling)
• Unio Specialty Care - A Genesis Healthcare Partners Facility — Bakersfield, California, United States (enrolling)
• Genesis Research — Downey, California, United States (enrolling)
• Urology Center of Southern California — Murrieta, California, United States (enrolling)
• Advanced Urology Institute — Daytona Beach, Florida, United States (enrolling)
• University of Florida — Gainesville, Florida, United States (enrolling)
• Advent Health — Orlando, Florida, United States (enrolling)
• Anna Arundel Urology — Annapolis, Maryland, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Michigan Institute of Urology — Troy, Michigan, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States (enrolling)
• Lowcountry Urology — North Charleston, South Carolina, United States (enrolling)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• Urology Partners of North Texas — Fort Worth, Texas, United States (enrolling)
• Baylor College of Medicine — Houston, Texas, United States (enrolling)
• Houston Methodist — Houston, Texas, United States (enrolling)
• Arizona Urology Specialists — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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