Actively Recruiting
A Phase 1/2a Study of STM-416 Administered Intraoperatively to Patients Undergoing Transurethral Resection of Bladder Tumor for Recurrent High-Grade Papillary Bladder Cancer
Led by SURGE Therapeutics · Updated on 2026-05-27
75
Participants Needed
20
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating STM-416, a drug studied for safety and tolerability in patients with recurrent high-grade papillary non-muscle-invasive bladder cancer (NMIBC) without carcinoma in situ (CIS). This first-in-human, Phase 1/2a, multi-center study includes patients who have completed standard of care (SOC) and have visible recurrent disease, focusing on those undergoing transurethral resection of bladder tumor (TURBT) without perioperative intravesical chemotherapy. The study aims to determine the safety of STM-416 administered during surgery and to explore its effects alongside SOC therapy given afterward. The study has two parts. Phase 1 is an open-label, dose-escalation phase where up to six increasing doses of STM-416 are given intraoperatively in 3 to 6 patients per dose to assess safety and tolerability. Phase 2a is a randomized, single-blind, dose-expansion phase comparing two doses of STM-416 administered during TURBT followed by SOC therapy. All participants receive SOC treatment after surgery. The study plans to enroll about 30 patients in Phase 1, with additional participants in Phase 2a. Participants will undergo TURBT surgery with STM-416 treatment during the procedure, followed by SOC therapy. Researchers will monitor dose-limiting toxicities and adverse events for up to 90 days in Phase 1 and track recurrence-free survival for up to 24 months in Phase 2a. Pharmacokinetics and pharmacodynamics of STM-416 will be studied at various time points after administration. Overall, participants will be followed regularly to assess safety, treatment response, and disease recurrence as part of the study lasting up to two years.
CONDITIONS
Brief 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...
- Are aged 18 years or older
- Have a history of pathologically confirmed high-grade Ta or T1 non-muscle-invasive bladder cancer without carcinoma in situ
- Have recurrent papillary disease seen on cystoscopy
- Are undergoing transurethral resection of bladder tumor (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 including hemoglobin ≥ 9.0 g/dL, absolute neutrophil count ≥ 1.5 x 10^9/L, platelet count ≥ 75 x 10^9/L, serum bilirubin ≤ 1.5 times institutional upper limit of normal, AST/ALT ≤ 2.5 times institutional upper limit of normal, and creatinine clearance ≥ 60 mL/min according to Cockcroft-Gault or 24-hour urine collection
You will not qualify if you...
- Have a history of carcinoma in situ or muscle-invasive bladder cancer
- Are receiving any other investigational agents
- Have a history of allergic reactions to compounds similar to resiquimod (R848) or excipients used in STM-416 such as poloxamer 407 or sodium hyaluronate
- Have uncontrolled illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness/social situations limiting compliance
- Have urinary tract infections of Grade 3 or higher
- Are women of childbearing potential (excluded in Phase 1 and Phase 2a to avoid bias)
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo transurethral resection of bladder tumor (TURBT) and receive a single intraoperative dose of STM-416.
1 surgical procedure visit (in-person)
Duration - Up to 24 months
Participants receive SOC therapy following TURBT as adjuvant treatment after STM-416 administration.
Periodic visits as part of SOC therapy
Duration - Up to 24 months
Participants are monitored for safety, pharmacokinetics, pharmacodynamics, and recurrence-free survival following treatment.
Multiple follow-up visits including assessments at Day 0, 24 hours, 48 hours, 21 days, 90 days, and up to study completion
Trial Site Locations
Total: 20 locations
1
East Valley Urology Center of Arizona
Mesa, Arizona, United States, 85206
Actively Recruiting
2
Arizona Urology Specialists
Tucson, Arizona, United States, 85715
Completed
3
Arkansas Urology
Little Rock, Arkansas, United States, 72211
Actively Recruiting
4
Unio Specialty Care - A Genesis Healthcare Partners Facility
Bakersfield, California, United States, 93301
Actively Recruiting
5
Genesis Research
Downey, California, United States, 90241
Actively Recruiting
6
Urology Center of Southern California
Murrieta, California, United States, 28078
Actively Recruiting
7
Advanced Urology Institute
Daytona Beach, Florida, United States, 32114
Actively Recruiting
8
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
9
Advent Health
Orlando, Florida, United States, 32803
Actively Recruiting
10
Anna Arundel Urology
Annapolis, Maryland, United States, 21410
Actively Recruiting
11
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
12
Michigan Institute of Urology
Troy, Michigan, United States, 48084
Actively Recruiting
13
The Ohio State University
Columbus, Ohio, United States, 43221
Actively Recruiting
14
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
15
Lowcountry Urology
North Charleston, South Carolina, United States, 29406
Actively Recruiting
16
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
17
Urology Partners of North Texas
Fort Worth, Texas, United States, 76132
Actively Recruiting
18
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
19
Houston Methodist
Houston, Texas, United States, 77030
Actively Recruiting
20
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
K
Kayti Aviano
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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