A Phase 1/2 Study With Open-Label, Dose Escalation Phase Followed by Single-Arm Expansion at the Maximum Tolerated Dose to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of NT219 Injection Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- TyrNovo Ltd.
- 入组人数
- 110
- 试验地点
- 10
- 主要终点
- Part 2: Incidence of treatment emergent adverse events
研究概览
简要总结
This is a phase 1/2, multi-center study with an open-label, dose escalation phase followed by a single-arm expansion phase to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of NT219 alone and in combination with ERBITUX® (cetuximab) in adults with recurrent and/or metastatic solid tumors.
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
Dose escalation of NT219 as a single agent
干预措施: NT219 (Drug)
Dose escalation of NT219 in combination with ERBITUX®
干预措施: NT219 and ERBITUX® - Dose Escalation (Drug)
Expansion cohort of NT219 in combination with ERBITUX®
干预措施: NT219 and ERBITUX® - Expansion (Drug)
结局指标
主要结局
Part 2: Incidence of treatment emergent adverse events
时间窗: Up to 24 months
Incidence of treatment emergent adverse events with NT219 administered in combination with ERBITUX®
Part 1: Incidence of treatment emergent adverse events
时间窗: Up to 24 months
Incidence of treatment emergent adverse events with single agent NT219
Part 3: Objective Response Rate
时间窗: Up to 24 months
Objective Response Rate when phase 2 dose of NT219 is used in combination with ERBITUX® in adults with recurrent and/or metastatic SCCHN
次要结局
- Plasma clearance [Cl](Up to 45 days after first study drug administration)
- Objective Response Rate when NT219 is used as monotherapy(Up to 24 months)
- Overall Survival when NT219 is used in combination with ERBITUX®(Up to 24 months)
- Maximum plasma concentration [Cmax](Up to 45 days after first study drug administration)
- Volume of distribution at stead-state [Vss](Up to 45 days after first study drug administration)
- Disease Control Rate when NT219 is used as monotherapy(Up to 24 months)
- Progression Free Survival when NT219 is used as monotherapy(Up to 24 months)
- Duration of Response when NT219 is used in combination with ERBITUX®(Up to 24 months)
- Time to Response when NT219 is used in combination with ERBITUX®(Up to 24 months)
- Disease Control Rate when NT219 is used in combination with ERBITUX®(Up to 24 months)
- Progression Free Survival when NT219 is used in combination with ERBITUX®(Up to 24 months)
- Time to Progression when NT219 is used in combination with ERBITUX®(Up to 24 months)
- Area under the plasma concentration curve [AUC](Up to 45 days after first study drug administration)
- Plasma half-life [t1/2](Up to 45 days after first study drug administration)
- Duration of Response when NT219 is used as monotherapy(Up to 24 months)
- Time to Response when NT219 is used as monotherapy(Up to 24 months)
- Time to Progression when NT219 is used as monotherapy(Up to 24 months)
- Overall Survival when NT219 is used as monotherapy(Up to 24 months)
- Objective Response Rate when NT219 is used in combination with ERBITUX®(Up to 24 months)