RecruitingPhase 1Phase 2NCT05710848

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

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


Sponsor

SURGE Therapeutics

Enrollment

75 participants

Start Date

Jul 11, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called STM-416 in patients with non-invasive bladder cancer that keeps coming back after standard treatment, given at the time of surgical tumor removal (TURBT). **You may be eligible if...** - You are 18 or older - You have high-grade non-muscle-invasive bladder cancer (cancer that has not grown into the bladder wall muscle) that has recurred after prior treatments - You are considered at high risk for the cancer coming back again - You are scheduled for a TURBT (bladder tumor removal via scope) without additional bladder-instilled chemotherapy - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have ever had cancer that grew into the bladder muscle wall, or a cancer type called carcinoma in situ (CIS) of the bladder - You are taking other experimental drugs - You are allergic to similar compounds in STM-416 - You have uncontrolled heart disease, active infection, or significant psychiatric illness - You are a woman of childbearing potential (in the earlier phases of this study) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSTM-416

STM-416 monotherapy


Locations(10)

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

View Full Details on ClinicalTrials.gov

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NCT05710848


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