A Phase Ib/II Study of BBI608 in Combination With Pembrolizumab in Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
the efficacy and safety of BBI608 in combination with pembrolizumab
详细描述
This is a multicenter, open-label Phase Ib/II study to exploratively evaluate the efficacy and safety of BBI608 in combination with pembrolizumab in patients with metastatic colorectal cancer (CRC) not responded to or intolerant of standard chemotherapy.The same analysis will be performed for the additional cohort to the Phase II part, consisting of patients with metastatic CMS 1 or 4, MMS, CRC not responsive to or intolerant of standard chemotherapy.
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
- 20 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
BBI608 + Pembrolizumab
BBI608 and Pembrolizumab
干预措施: Napabucasin (Drug)
BBI608 + Pembrolizumab
BBI608 and Pembrolizumab
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
ORR
时间窗: 1 year
Objective response rate determined by RECIST version 1.1: for additional cohort to the Phase II part
irORR
时间窗: 2 years
Immune-related objective response rate determined by their Response Evaluation Criteria In Solid Tumors (RESIST): for the Phase II part
次要结局
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](4 years)
- Pharmacokinetic(2 months)
- ORR(2 years)
- irORR(1 year)
- irPFS(12 weeks)
- Progression free survival rate at week 12 determined by the RECIST version 1.1(12 weeks)
- PFS(3 years)
- OS(4 years)
- DCR(2 years)
研究者
Takayuki Yoshino
Director of Gastrointestinal Oncology Division
National Cancer Center Hospital East