NCT07729371尚未招募1 期
An Open-Label, Phase 1b Trial to Assess the Safety and Efficacy of ST316 in Participants With Familial Adenomatous Polyposis (FAP)
Sapience Therapeutics0 个研究点目标入组 40 人开始时间: 2027年1月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Incidence of Treatment Related Adverse Events By CTCAE V5.0 Severity Grade
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ST
- •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):
- •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.
排除标准
- •Use of any other investigational agent or participation in an interventional clinical trial within 12 weeks prior to first dose of ST
- •Receipt of systemic oral corticosteroids within 30 days prior to first dose of ST
- •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 ST
- •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 ST
- •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 ST
- •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).
研究组 & 干预措施
Cohort 3
Experimental
Cohort 3 will be ST316 6mg/kg IV once weekly (QW) for 26 weeks
干预措施: ST316 IV (Drug)
Cohort 1
Experimental
Cohort 1 will be ST316 2mg/kg IV once weekly (QW) for 26 weeks
干预措施: ST316 IV (Drug)
Cohort 2
Experimental
Cohort 2 will be ST316 2mg/kg IV once every three weeks
干预措施: ST316 IV (Drug)
结局指标
主要结局
Incidence of Treatment Related Adverse Events By CTCAE V5.0 Severity Grade
时间窗: 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
时间窗: 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
次要结局
- Percentage change(1 year)
- Dose optimization(1 year)
- Regrowth of Polyps(1 year)
- New or Increased Polyp size(1 year)
研究者
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