An Open-label, Randomized, Multicenter, Phase 1b/2b Trial Investigating the Safety and Preliminary Antitumor Effects of Sym004 in Combination With Nivolumab Versus Nivolumab Monotherapy in EGFR-amplified Squamous Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Phase 1b: Determination of the Dose-Limiting Toxicities (DLT) and the MTD and/or RP2D of escalating doses of Sym004 in combination with a standard dose of nivolumab
研究概览
简要总结
This is a phase 1b/2b study investigating the safety and preliminary antitumor effects of Sym004 in combination with nivolumab versus nivolumab monotherapy when administered every second week.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Signed and dated written informed consent
- •Male or female ≥18 years of age at the time of informed consent
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Life expectancy >3 months assessed during Screening
- •Histologically or cytologically confirmed, locally advanced or metastatic squamous NSCLC
排除标准
- •Any antineoplastic agent (standard or investigational) within 2 weeks prior to starting trial treatment
- •Radiosurgery or radiotherapy for target lesions within 2 weeks prior to starting trial treatment
- •Prophylactic use of hematopoietic growth factors within 1 week prior to starting trial treatment
- •Active Central Nervous System (CNS) metastases or carcinomatous meningitis
- •Women who are pregnant
- •Women who are breastfeeding
研究组 & 干预措施
Nivolumab
Phase 2b, dose-expansion:
Receiving nivolumab monotherapy (Q2W)
干预措施: Nivolumab (Drug)
Sym004 + nivolumab
Phase 1b, dose-escalation:
Dose Level 1: Sym004 + nivolumab (Q2W)
Dose Level 2: Sym004 + nivolumab (Q2W)
Dose Level -1: Sym004 + nivolumab, if needed
干预措施: Sym004 (Drug)
Sym004 + nivolumab
Phase 1b, dose-escalation:
Dose Level 1: Sym004 + nivolumab (Q2W)
Dose Level 2: Sym004 + nivolumab (Q2W)
Dose Level -1: Sym004 + nivolumab, if needed
干预措施: Nivolumab (Drug)
Sym004 (RP2D) + nivolumab
Phase 2b, dose-expansion:
Receiving Sym004 in the RP2D in combination with nivolumab (Q2W)
干预措施: Sym004 (Drug)
Sym004 (RP2D) + nivolumab
Phase 2b, dose-expansion:
Receiving Sym004 in the RP2D in combination with nivolumab (Q2W)
干预措施: Nivolumab (Drug)
结局指标
主要结局
Phase 1b: Determination of the Dose-Limiting Toxicities (DLT) and the MTD and/or RP2D of escalating doses of Sym004 in combination with a standard dose of nivolumab
时间窗: 1 year
Phase 2b: Evaluation of the antitumor effects of the RP2D of Sym004 when administered in combination with a standard dose of nivolumab as measured by Response Rate
时间窗: 1.5 years
次要结局
未报告次要终点