A Safety Study of ST316 in Participants With Familial Adenomatous Polyposis (FAP).

This is a Phase 1b, open- label, dose-optimization study evaluating ST316 in adult participants with familial adenomatous polyposis (FAP) who have undergone colectomy and have recurrent polyps. This study uses a three-cohorts, sequential adaptive design to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ST316, as well as its preliminary efficacy in reducing polyp recurrence.

NCT Number	NCT07729371
Lead Sponsor	Sapience Therapeutics
Conditions	Familial Adenomatous Polyposis (FAP)
Enrollment	40 participants
Start Date	2027-01-04
Primary Completion	2028-12-31 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-12