RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-07-11

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05710848

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	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. 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.

Inclusion Criteria

Exclusion 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).

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.
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.

Contacts and Locations

Study Contact

Kayti Aviano

CONTACT

781-605-8632

kayti@surgetx.com

Principal Investigator

Seth Lerner, MD

PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Study Locations (Sites)

Arizona Urology Specialists

Tucson, Arizona, 85715

United States

University of Florida

Gainesville, Florida, 32608

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Duke Cancer Center

Durham, North Carolina, 27710

United States

The Ohio State University

Columbus, Ohio, 43221

United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572

United States

Urology Associates, P.C.

Nashville, Tennessee, 37209

United States

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

Baylor College of Medicine

Houston, Texas, 77030

United States

Houston Methodist

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: SURGE Therapeutics

Seth Lerner, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-11

Study Completion Date2025-12

Study Record Updates

Study Start Date2023-07-11

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Open-label
Dose escalation
STM-416
Resiquimod
Toll-like receptor 7/8
Non-Muscle Invasive Bladder Cancer
TURBT
Immunotherapy
BCG

Additional Relevant MeSH Terms

Non-muscle-invasive Bladder Cancer