Open-label, Single Arm, Tumor Imaging and Dosimetry Study of I-124 PGN650 in Advanced Solid Tumors
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- To estimate the intensity and distribution in critical and non-critical organs.
研究概览
简要总结
Tumor Imaging of I-124 PGN65 in Solid Tumors
详细描述
Up to 12 patients (6 men and 6 women) will be enrolled in this open-label, single-arm, tumor imaging and dosimetry study of I-124 PGN650 in solid tumors. All eligible patients who give written, informed consent and meet all inclusion criteria and no exclusion criteria, and whose laboratory results are within specified limits at the screening visit, will be enrolled. All study subjects will receive a single intravenous (IV) dose of I-124 PGN650. Study subjects will have whole body PET/CT imaging at three different timepoints with all patients having PET/CT at 0 to 60 minutes after injection of I-124 PGN650. Study subjects will then be assigned to either a 3 to 5-hour or 6 to 8-hour timepoint and either an 18 to 26 hour or 42 to 52 hour post-injection timepoint. Tumor and whole body radioactivity distribution will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
I-124 PGN650 for PET/CT
干预措施: I-124 PGN650 for PET/CT (Drug)
结局指标
主要结局
To estimate the intensity and distribution in critical and non-critical organs.
时间窗: Day 3
次要结局
- The presence of tumor imaging using I-124 PGN650 as a PS-targeting agent.(Day 1, Day 2 and Day 3)
- Demonstrate the safety of tumor imaging in patients with solid cancers.(Day 1, Day 2 and Day 3)
