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.
Cáncer de vejiga no músculo invasivo (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.
What is Involved?
Después del proceso de detección, los pacientes recibirán una dosis única del fármaco del estudio durante la cirugía de extirpación de la vejiga. Luego, se les dará seguimiento cercano durante los dos primeros días después de su procedimiento y posteriormente a intervalos regulares durante los próximos dos años.
Study Details
