JPRN-jRCT2080223817已完成1 期
An open label, Phase I study of BI 754091 monotherapy and combination therapy of BI 754091 and BI 754111 in Asian patients with advanced solid tumours
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 164
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Of full age (according to local legislation) at the time of signing of the informed consent form (ICF)
- •2.Women of childbearing potential (WOCBP) with negative serum pregnancy test at screening and men able to father a child, who agree to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. The requirement of contraception does not apply to women of no childbearing potential but they must have an evidence of such at screening
- •3.Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
排除标准
- •1.Major surgery (major according to the investigators assessment) performed within 12 weeks prior to study entry or planned within 12 months after screening, e.g. hip replacement
- •2.Patients who must or wish to continue the intake of restricted medications (see Section 4.2.2.2) or any drug considered likely to interfere with the safe conduct of the trial
- •3.Previous treatment with study medications in this trial
研究者
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