A Safety Study of ST316 in Participants With Familial Adenomatous Polyposis (FAP). (NCT07729371) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Safety Study of ST316 in Participants With Familial Adenomatous Polyposis (FAP).
40 participantsStarted 2027-01-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female participants aged 18 years or older at the time of informed consent.
. Ability to understand and willingness to sign a written informed consent document, prior to undertaking any study-related procedures.
. Confirmed Familial Adenomatous Polyposis (FAP) by molecular genetic testing and at least six polyps of 5-9 mm. Patients with FAP that present thyroid nodule and/ or desmoid tumors are eligible.
. History of prophylactic colectomy with either ileo-rectal anastomosis (IRA) or ileal pouch-anal anastomosis (IPAA), performed at least 12 months prior to screening, and without ongoing surgical complications.
. Presence of rectal/pouch polyps at baseline; polyps must be \<10 mm in size. If polyps ≥10 mm are identified during the baseline colonoscopy, they must be endoscopically removed at the time of the baseline colonoscopy before first dose of ST316.
. Willingness to forgo concurrent use of supplements containing, turmeric, omega-3 fatty acids, oral corticosteroids, NSAIDs, or other FAP-directed drug therapy for the duration of the study. Low-dose aspirin (80-100 mg daily) for cardioprotective indications will be permitted.
. Adequate organ function as defined by ALL of the following laboratory criteria (obtained within 28 days prior to first dose):
. Women of childbearing potential (WOCBP) and male participants who are sexually active with WOCBP must agree to use highly effective contraception from screening throughout study duration and for at least 90 days after last dose.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment Related Adverse Events By CTCAE V5.0 Severity Grade
Timeframe: From first dose through 30 days after last dose
2
Percentage change from Baseline in Colorectal/ Pouch Poly Burden (Sum in Diameters) at Month 6
. Use of any other investigational agent or participation in an interventional clinical trial within 12 weeks prior to first dose of ST316.
. Receipt of systemic oral corticosteroids within 30 days prior to first dose of ST316.
. Uncontrolled intercurrent illness or recent (within 4 weeks) major surgical procedure (excluding disease-related surgery, which should be \>12 months from screening) that would limit compliance or pose undue risk to the participant.
. History of invasive malignancy within 3 years prior to screening (exceptions: carcinoma of the cervix in situ, carcinoma in situ of any site, or basal/squamous cell carcinoma of the skin that has been completely excised).
. Concurrent use of anticoagulants with a risk of bleeding that may preclude study-related procedures (i.e., endoscopy and biopsies).
. Use of other NSAIDs (e.g., ibuprofen) exceeding 4 days per month, within 6 weeks prior to first dose of ST316.
. Regular use of aspirin at doses exceeding 700 mg per week.
. Treatment with other FAP-directed drug therapy (including sulindac, celecoxib, or fish oil) within 4 weeks prior to first dose of ST316.