An Open Label Phase I Study to Evaluate the Safety and Efficacy of OBP-301 With Pembrolizumab in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Dose limiting toxicity (DLT)
研究概览
简要总结
This is multicenter, open-label Phase I study to exploratively evaluate the efficacy and safety of OBP-301 in combination with Pembrolizumab in patients with advanced solid tumors.
详细描述
Phase 1a part:
To evaluate safety and tolerability in combination of OBP-301 and Pembrolizumab in patient with advanced or metastatic solid tumor and to determine recommended dose in phase 1b part.
Phase 1b part:
To evaluate safety and potential efficacy in combination of OBP-301 and Pembrolizumab in patients in expanded arm.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
OBP-301+Pembrolizumab
OBP-301+Pembrolizumab
干预措施: OBP-301 (Biological)
OBP-301+Pembrolizumab
OBP-301+Pembrolizumab
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Dose limiting toxicity (DLT)
时间窗: 4weeks
Dose limiting toxicity
次要结局
- Rate of adverse event(3 years)
- Response rate (RR)(3 years)
- Progression free survival (PFS)(3 years)
研究者
Toshihiko Doi
Chief / Division of experimental therapeutics
National Cancer Center Hospital East