A Phase 2, Open Label Study of REC-4881 in Participants With Unresectable Locally Advanced or Metastatic Cancer With AXIN1 or APC Mutation
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 13
- 主要终点
- Number of Participants with Dose Limiting Toxicities
研究概览
简要总结
This is a multi-center, open-label study to investigate the safety, efficacy and pharmacokinetics of REC-4881 (12 mg PO daily doses) for the treatment of participants with unresectable locally advanced or metastatic solid tumors with AXIN1 or APC mutation.
详细描述
Approximately 60 individuals will be enrolled in this open-label Phase 2 study, allocated 1:1 between the 2 cohorts - AXIN1 mutation or APC mutation. The purpose of the study is to investigate the safety, efficacy, and pharmacokinetics of REC-4881 for the treatment of participants with unresectable locally advanced or metastatic solid tumors with either mutation. Participants will receive treatment with REC-4881 (12mg PO daily) for up to 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •55 years of age or older with histologically-confirmed unresectable, locally advanced, or metastatic solid tumor with AXIN1 or APC mutation. If a participant has colorectal cancer, then they must be RAS / RAF wild type to enroll into the APC mutant cohort
- •Have experienced progressive disease, relapsed disease, or be intolerant to at least one established standard systemic anti-cancer treatment, or in the opinion of the Investigator have been considered ineligible for standard therapy
- •Measurable disease at baseline per RECIST 1.1 criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
排除标准
- •Received treatment with another mitogen-activated protein kinase (MEK) inhibitor within two months of first dose of REC-4881
- •Left ventricular ejection fraction (LVEF) <50% as measured by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
研究组 & 干预措施
AXIN1 Cohort
Participants will receive REC-4881 12mg PO dosed QD
干预措施: REC-4881 (Drug)
APC Cohort
Participants will receive REC-4881 12mg PO dosed QD
干预措施: REC-4881 (Drug)
结局指标
主要结局
Number of Participants with Dose Limiting Toxicities
时间窗: Up to 24 months
Objective Response Rate
时间窗: Up to 24 months
次要结局
- Area Under the Plasma Concentration-time Curve (AUC) of REC-4881(pre-dose and up to 24 months)
- Disease Control Rate(Up to 24 months)
- Duration of response(Up to 24 months)
- Duration of Stable Disease(Up to 24 months)
- Time to Response(Up to 24 months)