An Open Label, Multi-Center Phase 1b/2a Trial Investigating Different Doses of Sym004 in Combination With FOLFIRI in Patients With Metastatic Colorectal Cancer Progressing After First-Line Therapy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 8
- 主要终点
- Number of Participants With Adverse Events (AEs) by Nature, Severity, and Occurrence Measured From Baseline to End of Trial Participation, as Assessed by the Common Terminology Criteria for AEs (Version 4.03) (CTCAE v4.03).
研究概览
简要总结
This is a Phase 1b/2a study investigating the safety and efficacy of Sym004, an investigational medicinal product (IMP), in combination with FOLFIRI (chemotherapy) when administered every second week (Q2W).
详细描述
In the Phase 1b (Dose-Escalation) portion of the trial, patients will be sequentially enrolled to dose-escalation cohorts until establishment of the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of Sym004 in combination with FOLFIRI.
The Phase 2a (Dose-Expansion) portion of the trial is expected to begin after establishing the RP2D.
Note: In January 2017, the trial was terminated during Phase 1b and enrollment was prematurely discontinued. The primary objective changed to assess the safety of the treatment combination; collection of data for secondary and exploratory objectives was omitted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
Sym004 12 mg/kg + FOLFIRI
Phase 1b, Dose-Escalation: Dose Level 1
干预措施: Sym004 (Drug)
Sym004 12 mg/kg + FOLFIRI
Phase 1b, Dose-Escalation: Dose Level 1
干预措施: FOLFIRI (Drug)
Sym004 9 mg/kg + FOLFIRI
Phase 1b, Dose-Escalation: Dose Level -1
干预措施: Sym004 (Drug)
Sym004 9 mg/kg + FOLFIRI
Phase 1b, Dose-Escalation: Dose Level -1
干预措施: FOLFIRI (Drug)
Sym004 (RP2D) + FOLFIRI
Phase 2a, Dose-Expansion: Sym004 in the RP2D in combination with FOLFIRI
干预措施: Sym004 (Drug)
Sym004 (RP2D) + FOLFIRI
Phase 2a, Dose-Expansion: Sym004 in the RP2D in combination with FOLFIRI
干预措施: FOLFIRI (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) by Nature, Severity, and Occurrence Measured From Baseline to End of Trial Participation, as Assessed by the Common Terminology Criteria for AEs (Version 4.03) (CTCAE v4.03).
时间窗: 15 months
AEs were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. The incidence and type of AEs (e.g., treatment-emergent AE \[TEAE\]) were summarized according to MedDRA system organ classes and preferred terms. An AE was considered as treatment-emergent if it occurred after the first treatment administration.
次要结局
未报告次要终点