A Phase 1/2a Study of STM-416 Administered Intraoperatively (Bladder Cancer) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental drug called STM-416 (the study drug) is a safe and effective option for patients with a history of high grade, non-muscle invasive bladder cancer (cancer only within the bladder) whose disease has returned and who require an operation to remove cancer from the bladder.
What is the Condition Being Studied?
Non-Muscle Invasive Bladder Cancer (NMIBC)
Who Can Participate in the Study?
Adults ages 18+ who:
- Have a history of pathologically confirmed high grade Ta or T1 NMIBC without carcinoma in situ
- Have recurrent papillary disease seen on cystoscopy and are undergoing TURBT without perioperative intravesical chemotherapy
- Are considered high risk for recurrence
- Are not able to become pregnant
For more information, contact the study team at shawna.pochan@duke.edu.
Age Group
Adults
What is Involved?
After the screening process, patients will receive a one time dose of the study drug during their bladder removal surgery. They will then be followed closely for the first two days after their procedure and then at regular intervals for the next two years.
Study Details
Full Title
SURGE Therapeutics/ “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”
Principal Investigator
Urologic Oncologist
Protocol Number
IRB:
PRO00114565
NCT:
NCT05710848
Phase
Phase
I/II
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment