Familial Adenomatous Polyposis (FAP)Phase 1FAPNCT07729371
A Safety Study of ST316 in Participants With Familial Adenomatous Polyposis (FAP).
A Phase 1 study testing ST316 IV in people with Familial Adenomatous Polyposis (FAP), run by Sapience Therapeutics.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Familial Adenomatous Polyposis (FAP)
- What is being tested?
- ST316 IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2027to 31 Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Adequate organ function as defined by ALL of the following laboratory criteria (obtained within 28 days prior to first dose):
- Total bilirubin ≤1.5 × institutional ULN (unless Gilbert's syndrome). Alkaline phosphatase ≤1.5 × institutional ULN. AST (SGOT) ≤1.5 × institutional ULN. ALT (SGPT) ≤1.5 × institutional ULN. Serum creatinine ≤1.5 × institutional ULN.
- 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.
- Not currently breastfeeding. Women must agree not to breastfeed from first dose through 90 days after last dose.
Who cannot join
- 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.
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- 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.
- Any of the following findings on baseline biopsy obtained during screening colonoscopy:
- Colorectal cancer on biopsy.
- Duodenal cancer on biopsy.
- High-grade dysplasia found on polyp biopsy where the polyp has not been completely removed.
- A large polyp (>1 cm) not completely removed at baseline colonoscopy.
- QTcF >480 ms before first dose of ST316.
- Significant medical or psychiatric disorder that would preclude study participation or informed consent capacity.
- Known hypersensitivity to ST316 or any of its excipients.
- Currently pregnant, breastfeeding, or planning to conceive during the projected duration of the study (including 90 days post-last dose).
About this study
Official title: An Open-Label, Phase 1b Trial to Assess the Safety and Efficacy 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.
- Conditions
- Familial Adenomatous Polyposis (FAP)
- Being tested
- ST316 IV
- Keywords
- Familial adenomatous polyposis, FAP, Polyp recurrence, Colorectal polyps, Colectomy, Hereditary colorectal cancer, Desmoid tumors
- Medical subject headings
- Adenomatous Polyposis Coli, Desmoid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST316 IVDrug
ST316 will be administered as an IV weekly
ST316 IVDrug
ST316 will be administered once every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Cohort 1 will be ST316 2mg/kg IV once weekly (QW) for 26 weeks Receives: Drug: ST316 IV |
| Cohort 2 | Experimental | Cohort 2 will be ST316 2mg/kg IV once every three weeks Receives: Drug: ST316 IV |
| Cohort 3 | Experimental | Cohort 3 will be ST316 6mg/kg IV once weekly (QW) for 26 weeks Receives: Drug: ST316 IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Related Adverse Events By CTCAE V5.0 Severity Grade
Numbers and percentage of participants with treatment-related adverse events as assessed by severity grade (CTCAE V5); incidence of SAEs;
Measured: From first dose through 30 days after last dose
Percentage change from Baseline in Colorectal/ Pouch Poly Burden (Sum in Diameters) at Month 6
Percentage change from baseline to Month 6 in the sum of diameters of colorectal/ pouch and duodenal polyp burden (sum in diameters) as assessed by endoscopy
Measured: 1 year
Secondary outcomes (4)
Percentage change
Percentage change from baseline in colorectal/ pouch polyp burden and polyp count at month 3 and 9
Measured: 1 year
Dose optimization
Dose optimization will be assessed for further development
Measured: 1 year
Regrowth of Polyps
Regrowth of polyps from excised/ tattooed areas will be assessed
Measured: 1 year
New or Increased Polyp size
New or increased polyp size amenable for resection greater than 10mm
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start4 Jan 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Adenomatous Polyposis (FAP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sapience Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729371
- Sponsor's protocol ID
- ST316-102
- Acronym
- FAP
- Status last verified
- Aug 2026
- First submitted
- 22 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase 1b Trial to Assess the Safety and Efficacy of ST316 in Participants With Familial Adenomatous Polyposis (FAP)
- ClinicalTrials.gov ID
- NCT07729371
- Acronym / sponsor ID
- FAP / ST316-102
- Conditions
- Familial Adenomatous Polyposis (FAP)
- Keywords
- Familial adenomatous polyposis, FAP, Polyp recurrence, Colorectal polyps, Colectomy, Hereditary colorectal cancer, Desmoid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sapience TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: ST316 IVCohort 1 will be ST316 2mg/kg IV once weekly (QW) for 26 weeks |
| Cohort 2 | Experimental | Drug: ST316 IVCohort 2 will be ST316 2mg/kg IV once every three weeks |
| Cohort 3 | Experimental | Drug: ST316 IVCohort 3 will be ST316 6mg/kg IV once weekly (QW) for 26 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ST316 IVST316 will be administered as an IV weekly | Drug | Cohort 1 |
| ST316 IVST316 will be administered once every 3 weeks | Drug | Cohort 2, Cohort 3 |
Primary outcome
Incidence of Treatment Related Adverse Events By CTCAE V5.0 Severity Grade
Time frame: From first dose through 30 days after last dose
Numbers and percentage of participants with treatment-related adverse events as assessed by severity grade (CTCAE V5); incidence of SAEs;
Percentage change from Baseline in Colorectal/ Pouch Poly Burden (Sum in Diameters) at Month 6
Time frame: 1 year
Percentage change from baseline to Month 6 in the sum of diameters of colorectal/ pouch and duodenal polyp burden (sum in diameters) as assessed by endoscopy
4 secondary outcomes
Percentage change
Time frame: 1 year
Dose optimization
Time frame: 1 year
Regrowth of Polyps
Time frame: 1 year
New or Increased Polyp size
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ST316 IV in people with Familial Adenomatous Polyposis (FAP), run by Sapience Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Related Adverse Events By CTCAE V5.0 Severity Grade (time frame: From first dose through 30 days after last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.