An Open-label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characters, and Preliminary Efficacy of SCC244 in Patients with Advanced MET Alterations Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- DLT(Dose limit toxity)
研究概览
简要总结
This is a Phase 1a/1b multi-center and open label study to evaluate the safety, tolorability, pharmacokinetics and priliminary efficacy of SCC244 in advanced solid tumors patients with c-MET alteration
详细描述
This is a phase I study, its purpose to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD)/ biologically effective dose (BED) and the recommended phase II dose (RP2D) of SCC244 monotherapy in patients with advanced MET alterations solid tumors;
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
- 18 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
Dose escalation study of Gumarontinib
To determine the maximum tolerated dose (MTD) of Gumarontinib
干预措施: Gumarontinib Tablets (Drug)
结局指标
主要结局
DLT(Dose limit toxity)
时间窗: 35 days
To evaluate the DLT in patients with advanced solid tumor
MTD(Max tolerance does)
时间窗: 35 days
To evaluate the MTD in patients with advanced solid tumor
BED(Biological effective dose)
时间窗: 35 days
To evaluate the BED in patients with advanced solid tumor
objective response rate (ORR)
时间窗: 8 weeks
To evaluate the ORR in patients with advanced solid tumor in Ib
次要结局
未报告次要终点