A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 228 in Subjects With Selected Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- AMG 228 maximum observed concentration (Cmax)
研究概览
简要总结
The purpose of this study is to evaluate the safety, pharmacokinetics, anti-tumor activity, and identify a tolerable dose of AMG 228 in subjects with advanced solid tumors.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have a pathologically documented, definitively diagnosed, advanced solid tumor
- •Adequate hematological, renal, hepatic, and coagulation laboratory assessments
排除标准
- •Active autoimmune disease, history of autoimmune disease
- •Treatment with immune modulators including
- •Use of warfarin, factor Xa inhibitors, or direct thrombin inhibitors
- •Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days
- •Major surgery within 28 days of study day 1
研究组 & 干预措施
AMG 228 monotherapy
Part 1 and Part 2 of the study will both be with single agent AMG 228 in different selected tumor types.
干预措施: AMG 228 (Drug)
结局指标
主要结局
AMG 228 maximum observed concentration (Cmax)
时间窗: 9 months
Subject incidence of dose limiting toxicities (DLT)
时间窗: 9 months
Subject incidence of treatment-emergent adverse events
时间窗: 9 months
Subject incidence of treatment-related adverse events
时间窗: 9 months
Subject incidence of clinically significant changes in vital signs and physical assessments
时间窗: 9 months
Subject incidence of clinically significant changes in ECGs
时间窗: 9 months
Subject incidence of clinically significant changes in clinical laboratory tests
时间窗: 9 months
AMG 228 minimum observed concentration (Cmin)
时间窗: 9 months
AMG 228 area under the concentration-time curve (AUC)
时间窗: 9 months
AMG 228 half-life (t1/2)
时间窗: 9 months
次要结局
- Subject objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1(9 months)
- Incidence of anti-AMG 228 antibody formation(9 months)
- Activation status and changes in numbers of T regulator cells (Treg)(9 months)
- Subject objective response per immune-related Response Criteria (irRC)(9 months)
- Activation status of cytotoxic T lymphocytes (CTL)(9 months)
- Changes in numbers of cytotoxic T lymphocytes (CTL)(9 months)