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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RYZ211/212 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RYZ211/212 | Diagnostic Test | Imaging Agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Study duration (1 year) |
| 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) | Study duration (1 year) |
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Inclusion Criteria:
Exclusion Criteria:
Note: Additional criteria may apply and will be assessed by the study site
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| RayzeBio Clinical Trials | Contact | (619) 657-0057 | clinicaltrials@rayzebio.com |
| Name | Affiliation | Role |
|---|---|---|
| Freddy Escorcia | RayzeBio, Inc. | Study Director |
| Heying Duan | RayzeBio, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Facility | Christchurch | New Zealand |
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| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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