NCT05246995Unknown1 期
A Phase I, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI325, an Anti-CD73 Antibody, Combined With Sintilimab in Patients With Advanced Solid Tumor
Shandong Cancer Hospital and Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of patients with treatment related AEs
研究概览
简要总结
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI325 combined with Sintilimab in patients with advanced solid tumors
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（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
IBI325 and Sintilimab combination does-escalation
Experimental
干预措施: IBI325+Sintilimab (Drug)
结局指标
主要结局
Number of patients with treatment related AEs
时间窗: Up to 90 days post last dose
Number of patients who experienced a treatment related AEs from the first dose until 90days after the last dose
Number of patients with DLT
时间窗: 42 days post first dose
Number of patients who experienced a dose-limiting toxicity within the first 42 days after the first dose
次要结局
- Number of patients with response(Every 6 weeks until progressive disease or up to 24 months after treatment, whichever came first)
研究者
Jinming Yu
Director of the hospital
Shandong Cancer Hospital and Institute
研究点 (1)
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