jRCT2080224681已完成1 期
An open label, Phase I study of BI 836880 monotherapy and combination therapy of BI 836880 and BI 754091 in Japanese patients with advanced solid tumours
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Open label, uncontrolled, non-randomised, dose-escalation design
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Signed and dated written informed consent in accordance with International Council on Harmonisation (ICH) Good Clinical Practice (GCP) and local legislation prior to admission to the trial.
- •Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours (any type).
排除标准
- •Known hypersensitivity to the trial drugs or their excipients
- •Known HIV, HBV, or HCV infection
- •History of severe hypersensitivity reactions to other mAbs
结局指标
主要结局
-
safety - MTD. - Number of patients with DLTs in the MTD evaluation period.
次要结局
未报告次要终点
研究者
研究点 (1)
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