NCT02900157已完成1 期
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 9
- 主要终点
- Number of subjects that develop changes in detectable antidrug antibodies to MEDI9090
研究概览
简要总结
This is an open-label, study of MEDI9090 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of MEDI9090 in adult 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects
- •18 years and older
- •Must have histologic documentation of advanced solid tumors
- •Must have received and have progressed, are refractory or, intolerant to standard therapy and must not have a curative therapy option
排除标准
- •Concurrent enrollment in another clinical study
- •Prior participation in clinical studies that include durvalumab alone or in combination
- •Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
结局指标
主要结局
Number of subjects that develop changes in detectable antidrug antibodies to MEDI9090
时间窗: First dose of study medication through 6 months after the last dose of study medication
Number of subjects reporting infusion related reactions
时间窗: First dose of study medication through 30 days after the first dose of study medication
次要结局
- Number of subjects reporting adverse events(Screening through 3 months after last dose of study medication)
- Individual MEDI9090 concentrations(First dose of study medication through 3 months after the last dose of study medication)
- Number of subjects with vital sign abnormalities reported as adverse events(Screening through 3 months after the last dose of study medication)
- Number of subjects reporting serious adverse events(Screening through 3 months after the last dose of study medication)
- Number of subjects with ECG abnormalities reported as adverse events(Screening through 3 months after the last dose of study medication)
研究者
研究点 (9)
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