A Dose Escalation and Dose Expansion Study of WJ01024 to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy for Patients With Advanced Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- The incidence of adverse events (AE) and serious adverse events (SAE) were assessed
研究概览
简要总结
A clinical study of WJ01024 in subjects with advanced cancer in China, to evaluate the safety, tolerability, PK and efficacy of WJ01024. This study includes a dose escalation part and a dose expansion part. Patients receive WJ01024 on Day 1 and Day 3 of each week, 4 weeks as a cycle, until disease progression, or intolerable toxicity , withdrawal of consent, or end of the study, whichever occurs first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（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
WJ01024 60mg BIW repeat dose every 28 days
干预措施: WJ01024 (Drug)
WJ01024 5mg QD repeat dose every 28 days
干预措施: WJ01024 (Drug)
WJ01024 5mg BID repeat dose every 28 days
干预措施: WJ01024 (Drug)
WJ01024 10mg BID repeat dose every 28 days
干预措施: WJ01024 (Drug)
WJ01024 40mg BIW repeat dose every 28 days
干预措施: WJ01024 (Drug)
WJ01024 80mg BIW repeat dose every 28 days
干预措施: WJ01024 (Drug)
WJ01024 60mg QW repeat dose every 28 days
干预措施: WJ01024 (Drug)
WJ01024 80mg QW repeat dose every 28 days
干预措施: WJ01024 (Drug)
WJ01024 50mg QW repeat dose every 28 days
干预措施: WJ01024 (Drug)
WJ01024 40mg QW repeat dose every 28 days
干预措施: WJ01024 (Drug)
结局指标
主要结局
The incidence of adverse events (AE) and serious adverse events (SAE) were assessed
时间窗: 2 years
Incidence and severity of adverse events (AE) and serious adverse events (SAE) as assessed according to NCI-CTCAE 5.0, as well as abnormalities in vital signs, electrocardiogram, and laboratory tests
次要结局
- Kel(2 years)
- t1/2(2 years)
- CL/F(2 years)
- Vd/F(2 years)
- Rac(2 years)
- PFS(2 years)
- DOR(2 years)
- DCR(2 years)
- Cmax(2 years)
- Tmax(2 years)
- AUC0-t(2 years)
- AUC0-inf(2 years)
- ORR(2 years)