A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer
NCT ID: NCT05710848
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
75 participants
INTERVENTIONAL
2023-07-11
2025-12-31
Brief Summary
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Detailed Description
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Phase 1 is an open-label, single-treatment, dose-escalation study to evaluate the safety and tolerability of up to 6 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 30 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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STM-416
STM-416
STM-416
STM-416 monotherapy
Interventions
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STM-416
STM-416 monotherapy
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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SURGE Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Seth Lerner, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Arizona Urology Specialists
Tucson, Arizona, United States
University of Florida
Gainesville, Florida, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Duke Cancer Center
Durham, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology Associates, P.C.
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Christina Montijo
Role: primary
Casey Walsh
Role: primary
Shawna Pochan
Role: primary
Kendall Lewis
Role: primary
Jessica Richardson
Role: primary
Joe Wallace
Role: primary
Jose Santoyo
Role: primary
Sharon Harrison
Role: primary
Taliah Muhammad
Role: primary
Other Identifiers
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STM-416-01
Identifier Type: -
Identifier Source: org_study_id