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

NCT07729371 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-12

No results posted yet for this study

Summary

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.

Conditions

  • Familial Adenomatous Polyposis (FAP)

Interventions

DRUG

ST316 IV

ST316 will be administered as an IV weekly

DRUG

ST316 IV

ST316 will be administered once every 3 weeks

Sponsors & Collaborators

  • Sapience Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-04
Primary Completion
2028-12-31
Completion
2029-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07729371 on ClinicalTrials.gov