A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Japanese Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- The number of subjects experiencing dose-limiting toxicities (DLTs)
研究概览
简要总结
This is a Phase 1, open-label study evaluate the safety, tolerability, pharmacokinetics, immunogenicity and anti-tumor activity of MEDI5752 in Japanese patients with advanced solid solid tumors.
详细描述
<Objectives>
Primary Objective:
To evaluate the safety and tolerability of MEDI5752 in Japanese subjects with advanced solid tumors.
Secondary Objective:
To assess the anti-tumor activity and efficacy of MEDI5752. To describe the pharmacokinetics of MEDI5752.
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 120 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
MEDI5752 monotherapy
干预措施: MEDI5752 (Biological)
结局指标
主要结局
The number of subjects experiencing dose-limiting toxicities (DLTs)
时间窗: Up to 21 days following the first dose
The primary endpoint is as assessed by the number of subjects experiencing dose limiting toxicities (DLTs) as defined by the protocol.
The number of subjects experiencing treatment related adverse events (AEs)
时间窗: From the time of informed consent through 90 days following termination of treatment with investigational product
The primary endpoint is as assessed by the number of subjects experiencing adverse events (AEs) graded per NCI CTCAE v5.0.
The number of subjects experiencing treatment related serious adverse events (SAEs)
时间窗: From the time of informed consent through 90 days following termination of treatment with investigational product
The primary endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v5.0.
The number of subjects experiencing changes from baseline in vital signs reported as adverse events
时间窗: From the time of informed consent through 90 days following termination of treatment with investigational product
The primary endpoint is as assessed by the number of subjects experiencing clinically significant changes in vital signs from baseline.
The number of subjects experiencing abnormal laboratory evaluations
时间窗: From the time of informed consent through 90 days following termination of treatment with investigational product
The primary endpoint is as assessed as the number of subjects experiencing changes in laboratory parameters from baseline.
The number of subjects experiencing abnormal electrocardiograms (ECG) reported as Adverse Events
时间窗: From the time of informed consent through 90 days following termination of treatment with investigational product
The primary endpoint is as assessed by the the number of subjects experiencing clinically significant changes in ECG parameters from baseline.
次要结局
- PD-L1 Expression in subjects with advanced solid tumors(To be assessed at at baseline)
- Preliminary anti-tumor activitiy of MEDI5752 using Objective Response based on RECIST v1.1(From the first dose of study drug through the date of documented progression, end of study, or date of death until study completion assessed up to 16 months.)
- Pharmacokinetics of MEDI5752(At Cycle1Day1, ,Cycle1Day2, Cycle1Day3, Cycle1Day8, Cycle1Day15, Cycle2Day1, Cycle2Day8, Cycle3Day1, Cycle4Day1, Cycle5Day1, Cycle6Day1, Cycl7Day1, every 6 weeks after Cycle7Day1 (each cycle is 21 days) and up to 90 days following end of treatment.)
- Immunogenicity of MEDI5752(At Cycle1Day1, Cycle1Day8, Cycle1Day15, Cycle2Day1, Cycle2Day8, Cycle3Day1, Cycle4Day1, Cycle5Day1, Cycle6Day1, Cycl7Day1, every 6 weeks after Cycle7Day1 (each cycle is 21 days) and up to 90 days following end of treatment.)