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.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Have a history of pathologically confirmed high grade Ta or T1 NMIBC without carcinoma in situ</li>
<li>Have recurrent papillary disease seen on cystoscopy and are undergoing TURBT without perioperative intravesical chemotherapy</li>
<li>Are considered high risk for recurrence</li>
<li>Are not able to become pregnant</li></ul>
For more information, contact the study team at <a href= "mailto: shawna.pochan@duke.edu">shawna.pochan@duke.edu.</a>
<li>Have a history of pathologically confirmed high grade Ta or T1 NMIBC without carcinoma in situ</li>
<li>Have recurrent papillary disease seen on cystoscopy and are undergoing TURBT without perioperative intravesical chemotherapy</li>
<li>Are considered high risk for recurrence</li>
<li>Are not able to become pregnant</li></ul>
For more information, contact the study team at <a href= "mailto: shawna.pochan@duke.edu">shawna.pochan@duke.edu.</a>
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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?
Study Website
Principal Investigator
Michael
Abern
Protocol Number
PRO00114565
NCT ID
NCT05710848
Phase
I/II
Enrollment Status
Open to Enrollment