Actively Recruiting
A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer
Led by SURGE Therapeutics · Updated on 2026-02-19
75
Participants Needed
10
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- History of pathologically confirmed high-grade Ta or T1 non-muscle-invasive bladder cancer without carcinoma in situ
- Undergoing TURBT without perioperative intravesical chemotherapy
- Considered high risk for recurrence
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Adequate organ and marrow function including hemoglobin ≥ 9.0 g/dL, absolute neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 75 × 10^9/L, serum bilirubin ≤ 1.5 × institutional upper limit of normal, AST/ALT ≤ 2.5 × institutional upper limit of normal, and creatinine clearance ≥ 60 mL/min by Cockcroft-Gault formula or 24-hour urine collection
You will not qualify if you...
- History of carcinoma in situ or muscle-invasive bladder cancer
- Receiving any other investigational agents
- History of allergic reactions to resiquimod-like compounds or ingredients in STM-416 including poloxamer 407 and sodium hyaluronate
- Uncontrolled illnesses such as active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions limiting study compliance
- Urinary tract infections of National Cancer Institute Common Terminology Criteria for Adverse Events Grade 3 or higher
- Women of childbearing potential (in Phase 1 and Phase 2a only)
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Arizona Urology Specialists
Tucson, Arizona, United States, 85715
Actively Recruiting
2
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
5
The Ohio State University
Columbus, Ohio, United States, 43221
Actively Recruiting
6
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
7
Urology Associates, P.C.
Nashville, Tennessee, United States, 37209
Actively Recruiting
8
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
9
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
10
Houston Methodist
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
K
Kayti Aviano
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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