A Phase 0 Imaging Study to Assess the Feasibility, Biodistribution, and Dosimetry of the Imaging Agent in Subjects With Metastatic Clear Cell Renal Cell Cancer (RCC).
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To assess the tolerability of RYZ512 in subjects with metastatic clear cell RCC.
研究概览
简要总结
This imaging study aims to assess the feasibility, biodistribution, and dosimetry of the imaging agent in Subjects with Metastatic Clear Cell Renal Cell Cancer (RCC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •At least 18 years old at the time of signing the informed consent form (ICF).
- •Biopsy proven metastatic clear cell renal cell carcinoma (RCC)
排除标准
- •Subjects taking below mentioned medications that cannot be stopped 5 half-lives prior to RYZ512 administration and cannot be restarted until all study-related imaging is completed: Anticonvulsants, Antipsychotics, Carbonic Anhydrase inhibitors, COX-2 Inhibitors, Sulfatase Inhibitors, Sulfonamides
- •Women of Childbearing Potential that are pregnant or breastfeeding.
- •Note: Additional criteria may apply and will be assessed by the study site
结局指标
主要结局
To assess the tolerability of RYZ512 in subjects with metastatic clear cell RCC.
时间窗: Study duration (6 months)
To assess the tolerability of RYZ512 by monitoring incidence and severity of AEs by NCI CTCAE v5, including SAEs, and other safety findings in subjects with metastatic clear cell RCC.
To evaluate the (long) biodistribution of RYZ512 in subjects with metastatic clear cell RCC.
时间窗: Study duration (6 months)
To evaluate the (long) biodistribution of RYZ512 by using visual assessment of location, extent, and intensity of RYZ512 uptake in critical organs and tumors in subjects with metastatic clear cell RCC.
To evaluate the radiation absorbed doses of RYZ512 in critical organs and tumors as well as the effective dose in subjects with metastatic clear cell RCC.
时间窗: Study duration (6 months)
To evaluate the radiation absorbed doses of RYZ512 using calculated mean TIAC (MBq·hr/MBq), radiation absorbed dose coefficients (mGy/MBq) and absorbed dose (Gy) to critical organs (e.g., stomach, liver, kidneys, bone marrow), calculated mean TIAC (MBq·hr/MBq) and radiation absorbed dose coefficients (mGy/MBq) and absorbed dose (Gy) to tumors, calculated whole-body effective dose (mSv/MBq) in critical organs and tumors as well as the effective dose in subjects with metastatic clear cell RCC.
To assess the tolerability of the imaging agent subjects with metastatic clear cell RCC.
时间窗: Study duration (6 months)
To assess the tolerability of RYZ512 by monitoring incidence and severity of AEs by NCI CTCAE v5, including SAEs, and other safety findings in subjects with metastatic clear cell RCC.
次要结局
未报告次要终点