A Phase I, First in Human, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WGI-0301, a Lipid Nanoparticle Suspension of Akt-1 Antisense Oligonucleotide, in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Recommended Phase 2 Dose of WGI-0301
研究概览
简要总结
The purpose of this study is to learn about the effects of a study medicine, WGI-0301 to find the best dose for treating solid tumors, and to see how safe and tolerable the study drug is for patients with solid tumors.
The study is also done to learn how the study drug is taken up by your body; this is called Pharmacokinetic (PK) studies and how the study drug affects the body; this is called Pharmacodynamics (PD)
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
WGI-0301
干预措施: WGI-0301 (Drug)
结局指标
主要结局
Recommended Phase 2 Dose of WGI-0301
时间窗: Approximately 16 months
Based on dose-limiting toxicities, the maximal tolerated dose and all other available safety, pharmacokinetic/pharmacodynamic data as assessed by the cohort review committee
Safety and tolerability
时间窗: Approximately 16 months
Incidence and severity of treatment-related adverse events and serious adverse events
次要结局
- Half-life(Approximately 16 months)
- Maximum plasma concentration(Approximately 16 months)
- Area under the curve(Approximately 16 months)
- Time of maximum plasma concentration(Approximately 16 months)