Imaging Study in Metastatic UC, HR+ and HER2- Breast Cancer, TNBC, and NSCLC
A Phase 0 Imaging Study to Assess the Feasibility, Biodistribution, and Dosimetry of the Imaging Agent in Metastatic Urothelial Cancer (UC), Hormone Receptor-Positive (HR+) and Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Breast Cancer, Triple-Negative Breast Cancer (TNBC), and Non-Small-Cell Lung Cancer (NSCLC)
This imaging study aims to assess the feasibility, biodistribution, and dosimetry of the imaging agent in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC.
研究概览
研究类型
注册 (估计的)
阶段
- 第一阶段早期
联系人和位置
学习联系方式
- 姓名：RayzeBio Clinical Trials
- 电话号码：(619) 657-0057
- 邮箱：clinicaltrials@rayzebio.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Are at least 18 years old at the time of signing the informed consent form (ICF)
- Have biopsy proven metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC
Exclusion Criteria:
- For Women of Childbearing Potential: Are pregnant or breastfeeding
Note: Additional criteria may apply and will be assessed by the study site
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：RYZ211/212
|
Imaging Agent |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To evaluate the biodistribution of RYZ211 in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC
大体时间：Study duration (1 year)
|
To evaluate the biodistribution of RYZ211 using SUV (mean, maximum, and peak) of critical organs (blood pool, salivary glands, thyroid, pancreas, liver, kidney [cortex], bone) and tumors; tumor-to-normal organ tracer uptake ratios in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC |
Study duration (1 year)
|
|
To evaluate the long biodistribution and radiation absorbed doses in critical organs and tumors, and the effective dose of RYZ212 in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC
大体时间：Study duration (1 year)
|
To evaluate the long biodistribution and radiation absorbed doses in critical organs and tumors, and the effective dose of RYZ212 by using calculated mean TIAC (MBq · h/MBq), radiation absorbed dose coefficients (mGy/MBq) and absorbed dose (Gy) to critical organs (salivary glands, thyroid, pancreas, liver, kidneys, bone marrow), calculated mean TIAC (MBq · h/MBq) and radiation absorbed dose coefficients (mGy/MBq) and absorbed dose (Gy) to tumors, calculated whole-body effective dose (mSv/MBq) |
Study duration (1 year)
|
合作者和调查者
调查人员
- 研究主任：Freddy Escorcia、RayzeBio, Inc.
- 研究主任：Heying Duan、RayzeBio, Inc.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.