Phase Ib First in Human Dose Escalation of GT103 in Refractory, Advanced Stage Non-Small Cell Lung Cancer (TOP 1902)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 3
- 主要终点
- Time for the concentration of GT103 to reach half of the level administered
研究概览
简要总结
The purpose of this research study is to determine the maximum tolerated dose of GT103 and investigate the safety and effectiveness of the study drug.
详细描述
This is a Phase Ib First in Human Dose Escalation of GT103 in Refractory, Advanced Stage (III/IV) and Recurrent Non-Small Cell Lung Cancer.
Patients with histologically confirmed recurrent, advanced stage of lung cancer, and there are no other standard therapies available may be eligible to participate in this study.
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
GT103
Participants will receive GT103 every 3 weeks. GT103 will be escalated from .3mg/kg up 10 to mg/kg or until MTD is found
干预措施: GT103 (Drug)
结局指标
主要结局
Time for the concentration of GT103 to reach half of the level administered
时间窗: 2 years
Recommended phase II dose (RP2D) of GT103
时间窗: 2 years
Recommended dose for the Phase II portion of the study
To determine the maximum tolerated dose (MTD), if any
时间窗: 2 years
The number and proportion of subjects at each dose level who experience a DLT
次要结局
- Response Rate(2 years)
- Progression-Free Survival(2 years)
- Overall Survival(2 years)
研究者
Edward Patz
James and Alice Chen Distinguished Professor of Radiology
Duke University