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This imaging study aims to assess the feasibility, biodistribution, and dosimetry of a novel Carbonic Anhydrase IX (CAIX) Binder in Subjects with Metastatic Clear Cell Renal Cell Cancer (RCC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imaging Study of a CAIX Binder in Metastatic Clear Cell RCC. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RYZ512 | Diagnostic Test | Imaging Agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the tolerability of RYZ512 in subjects with metastatic clear cell RCC. | 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. | Study duration (6 months) |
| To evaluate the (long) biodistribution of RYZ512 in subjects with metastatic clear cell RCC. | 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. | Study duration (6 months) |
| 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. | 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. | Study duration (6 months) |
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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, MD, PhD | RayzeBio, Inc. | Study Director |
| Heying Duan, MD | RayzeBio, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Facility | Christchurch | New Zealand |
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| ID | Term |
|---|---|
| C538445 | Clear-cell metastatic renal cell carcinoma |
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