Study of REGN1400 Alone and in Combination With Erlotinib or Cetuximab in Patients With Certain Types of Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 主要终点
- The primary objective of the study is to characterize the safety profile of REGN1400 alone and in combination with erlotinib or cetuximab
研究概览
简要总结
This is an open-label, multicenter, ascending multiple dose study of REGN1400 alone and in combination with erlotinib or cetuximab administered to patients with certain types of cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
Cohort 1
Dosing regimen 1: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
干预措施: REGN1400 (Drug)
Cohort 1
Dosing regimen 1: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
干预措施: Erlotinib (Drug)
Cohort 1
Dosing regimen 1: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
干预措施: Cetuximab (Drug)
Cohort 2
Dosing regimen 2: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
干预措施: REGN1400 (Drug)
Cohort 2
Dosing regimen 2: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
干预措施: Erlotinib (Drug)
Cohort 2
Dosing regimen 2: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
干预措施: Cetuximab (Drug)
Cohort 3
Dosing regimen 3: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
干预措施: REGN1400 (Drug)
Cohort 3
Dosing regimen 3: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
干预措施: Erlotinib (Drug)
Cohort 3
Dosing regimen 3: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
干预措施: Cetuximab (Drug)
结局指标
主要结局
The primary objective of the study is to characterize the safety profile of REGN1400 alone and in combination with erlotinib or cetuximab
时间窗: Day 1 - Day 28
Safety will be assessed through analysis of laboratory data, physical examination findings and vital signs according to the schedule of assessments, in addition to the spontaneous reporting of adverse events according to CTCAE version 4.
次要结局
- Recommended Phase 2 Dose (RP2D)(Day 1 to Day 28)