About this trial
This imaging study aims to assess the feasibility, biodistribution, and dosimetry of a TROP2 binder in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
TROP2-targeting antibody-drug conjugates (ADCs) such as sacituzumab govitecan or datopotamab deruxtecan, should be discontinued at least 90 days prior to administration of RYZ211 and RYZ212
For Women of Childbearing Potential: Are pregnant or breastfeeding
Trial design
Single group
Treatments tested in this trial
RYZ211/212
Diagnostic testImaging Agent
Treatment groups
Trial outcomes
Primary outcomes
To evaluate the biodistribution of RYZ211 (68Ga-RAYZ-2453) in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC
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 (177Lu-RAYZ-2453) 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 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)
Sponsors and contacts
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