Metastatic Urothelial CarcinomaBreast CancerTNBC - Triple-Negative Breast CancerHormone Receptor Positive HER-2 Negative Breast CancerNSCLC
Investigational drug(s) / intervention(s)
RYZ211/212
RYZ211/212: Imaging Agent
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
To evaluate the biodistribution of RYZ211 in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC — 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
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 — 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)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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