jRCT2031220130进行中（未招募）不适用
A phase I study of TRK-950 in patients with advanced solid tumors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 19
- 主要终点
- Number of participants with adverse events of special interest (AESIs)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Part 1: Patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who have been refractory or intolerant to standard therapies or for whom no standard therapy exists
- •Part 2: Patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who are eligible for standard therapy with NIVO 240 mg alone administered at 2-week intervals.
- •Patients with life expectancy of at least 3 months after the start of study drug administration
- •Patients aged >=18 years at the time of consent
- •Patients who are able to provide written consent in person to be a subject of this study
- •A negative pregnancy test before enrollment (if female of childbearing potential)
排除标准
- •Patients with active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
- •Pregnant women (including those who are considered possibly pregnant based on history taking, etc. by physician) or breastfeeding women (interrupting breastfeeding to enroll is also not allowed)
- •Patients who are unwilling or unable to comply with the protocol specified procedures
- •Patients who are positive for human immunodeficiency virus (HIV) antibody
- •Patients who meet any of the following conditions on hepatitis B virus (HBV) and hepatitis C virus (HCV) testing
- •Patients who are positive for hepatitis B surface antigen (HBsAg)
- •Patients who are positive for HCV RNA
结局指标
主要结局
Number of participants with adverse events of special interest (AESIs)
时间窗: through study completion, an average of 1 year
Number of participants with AESIs will be assessed.
Number of participants with dose-limiting toxicities (DLTs)
时间窗: Up to Day 28
Number of participants with DLTs will be determined.
Number of participants with adverse events (AEs)
时间窗: through study completion, an average of 1 year
Number of participants with AEs will be assessed.
Number of participants with serious adverse events (SAEs)
时间窗: through study completion, an average of 1 year
Number of participants with SAEs will be assessed.
次要结局
未报告次要终点
研究者
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