A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients With Non-Hodgkin B-cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Part B: objective response rate (ORR)
研究概览
简要总结
This study will treat patients with non-Hodgkin B-cell lymphoma who have relapsed from, refractory or intolerant to prior therapy. This study will help understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy.
详细描述
A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients with Non-Hodgkin B-cell Lymphoma. This study includes dose escalation (Part A) and dose expansion (Part B).
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 —（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
daily dose of DZD9008
daily dose of DZD9008
干预措施: DZD9008 (Drug)
结局指标
主要结局
Part B: objective response rate (ORR)
时间窗: Through study completion, an average of 1.5 years
Part A: Incidence of Treatment-Emergent Adverse Events
时间窗: Through study completion, an average of 1.5 years
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0
次要结局
- Maximum Plasma DZD9008 concentration(up to 16 weeks)
- Plasma DZD9008 concentration- Area Under the Curve(up to 16 weeks)