A Phase 1/1b, Open-Label, Multicenter, Repeat-Dose, Dose-Selection Study of Ciforadenant as Single Agent and in Combination With Atezolizumab in Patients With Selected Incurable Cancers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 502
- 试验地点
- 20
- 主要终点
- Incidence of dose-limiting toxicities (DLTs) of ciforadenant as a single agent and in combination with atezolizumab
研究概览
简要总结
This is a phase 1/1b open-label, multicenter, dose-selection study of ciforadenant, an oral small molecule targeting the adenosine-A2A receptor on T-lymphocytes and other cells of the immune system. This trial will study the safety, tolerability, and anti-tumor activity of ciforadenant as a single agent and in combination with atezolizumab, a PD-L1 inhibitor against various solid tumors. Ciforadenant blocks adenosine from binding to the A2A receptor. Adenosine suppresses the anti-tumor activity of T cells and other immune cells.
详细描述
This is a phase 1/1b open-label, multicenter, dose-selection study of ciforadenant, an oral small molecule targeting the adenosine-A2A receptor on T-lymphocytes and other cells of the immune system. This trial will study the safety, tolerability, and anti-tumor activity of ciforadenant as a single agent and in combination with atezolizumab, an intravenous PD-L1 inhibitor. Ciforadenant blocks adenosine from binding to the A2A receptor. Adenosine suppresses the anti-tumor activity of T cells and other immune cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 - Closed
Ciforadenant
干预措施: Ciforadenant (Drug)
Cohort 2 - Closed
Ciforadenant
干预措施: Ciforadenant (Drug)
Cohort 3 - Closed
Ciforadenant
干预措施: Ciforadenant (Drug)
Cohort 4
Ciforadenant + atezolizumab
干预措施: Ciforadenant + atezolizumab (Drug)
Cohort 5 - Closed
Ciforadenant
干预措施: Ciforadenant (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicities (DLTs) of ciforadenant as a single agent and in combination with atezolizumab
时间窗: 28 days following first administration of ciforadenant
Objective response rate per RECIST v1.1 criteria of ciforadenant as a single agent and in combination with atezolizumab
时间窗: From start of treatment to end of treatment, up to 72 months
Incidence of treatment-emergent adverse events, as assessed by NCI CTCAE v.4.03, of ciforadenant as a single agent and in combination with atezolizumab
时间窗: Continuously, up to 72 months
Identify the MDL (maximum dose level) of single agent ciforadenant
时间窗: From start of treatment to end of treatment, up to 72 months.
Mean and median Area under the curve (AUC) of ciforadenant
时间窗: Up to 12 months
Mean and median Maximum concentration (Cmax) of ciforadenant
时间窗: Up to 12 months
次要结局
未报告次要终点