A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Handok Inc.
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- the recommended Phase 2 dose(RP2D) or the maximum tolerated dose(MTD) of NOV1601
研究概览
简要总结
This study is a first-in-human (FIH) study which is required to understand the PK characteristics, MTD, and safety profile of NOV1601(CHC2014) in subjects with solid organ malignancies.
详细描述
This is the first-in-human, Phase 1, open-label, multicenter, dose-escalation study to investigate the safety, tolerability, PK, and clinical activity of NOV1601(CHC2014) in subjects with solid organ malignancies. The primary goal of the study is to determine the RP2D of NOV1601(CHC2014) in adult subjects with solid organ malignancies.
Dose escalation will follow a 3+3 design and will be based on prior cohort review. There will be 2 branches of the dosing schedule, once a day(QD) and twice daily(BID).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
NOV1601(CHC2014)
a highly selective pan-TRK(tropomyosin receptor kinase) inhibitor targeting tropomyosin receptor kinase A(TRKA), tropomyosin receptor kinase B(TRKB), and tropomyosin receptor kinase C(TRKC)
干预措施: NOV1601(CHC2014) (Drug)
结局指标
主要结局
the recommended Phase 2 dose(RP2D) or the maximum tolerated dose(MTD) of NOV1601
时间窗: Subjects will be treated and observed for dose-limiting toxicity(DLT) through the end of the first cycle (Days 1-28).
MTD will be the RP2D, based on the pharmacokinetic(PK) profiles and safety profiles as assessed by the Safety Monitoring Committee (SMC).
次要结局
- Number of participants with treatment-related adverse events(TEAE) and serious adverse events(SAE)(Maximum 2 years)