SURGE Therapeutics
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.
Non-muscle-invasive Bladder Cancer
STM-416
Phase 1
Phase 2
This is a 2-part, multicenter, first-in-human (FIH), Phase 1/2a study in patients with 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. All patients will receive relevant SOC therapy following TURBT. SOC will be administered in the adjuvant setting. Phase 1 is an open-label, single-treatment, dose-escalation study to evaluate the safety and tolerability of up to 4 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 24 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.}}
Study Type : | Interventional |
Estimated Enrollment : | 75 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
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 |
Actual Study Start Date : | July 11, 2023 |
Estimated Primary Completion Date : | June 2024 |
Estimated Study Completion Date : | September 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: STM-416 STM-416 |
Drug: STM-416 |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Arizona Urology Specialists
Tucson, Arizona, United States, 85715
Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Recruiting
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Recruiting
Urology Associates, P.C.
Nashville, Tennessee, United States, 37209
Recruiting
University of Texas Southwestern Medical Center
dallas, Texas, United States, 75390
Recruiting
Baylor College of Medicine
Houston, Texas, United States, 77030