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.
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.
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).
Sequential
ST316 IV
DrugST316 will be administered as an IV weekly
ST316 IV
DrugST316 will be administered once every 3 weeks
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;
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
Percentage change
Percentage change from baseline in colorectal/ pouch polyp burden and polyp count at month 3 and 9
Dose optimization
Dose optimization will be assessed for further development
Regrowth of Polyps
Regrowth of polyps from excised/ tattooed areas will be assessed
New or Increased Polyp size
New or increased polyp size amenable for resection greater than 10mm
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