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RYZ512 · 1 trial · 1 indication
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Imaging Study of a CAIX Binder in Metastatic Clear Cell RCC. | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| RYZ512 | DIAGNOSTIC_TEST | Imaging Agent |
Inclusion Criteria: * At least 18 years old at the time of signing the informed consent form (ICF). * Biopsy proven metastatic clear cell renal cell carcinoma (RCC) Exclusion Criteria: * Subjects taking below mentioned medications that cannot be stopped 5 half-lives prior to RYZ512 administration...
RYZ512 is an investigational imaging agent being studied for use in metastatic clear cell renal cell carcinoma. It is designed as a CAIX binder for imaging purposes, and it is currently in early Phase 1 clinical development. The drug is not yet approved and remains under investigation.
RYZ512 targets CAIX, a carbonic anhydrase IX protein that is commonly expressed in clear cell renal cell carcinoma. As a CAIX binder, it is being evaluated as an imaging agent to visualize tumors in patients with metastatic clear cell renal cell carcinoma.
RYZ512 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting an early Phase 1 clinical trial to evaluate the drug as an imaging agent for metastatic clear cell renal cell carcinoma.
RYZ512 is in early Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing trial is an imaging study designed to assess the drug's performance in patients with metastatic clear cell renal cell carcinoma.
RYZ512 is being studied in one early Phase 1 clinical trial with the identifier NCT07671417. This imaging study is enrolling 10 participants with metastatic clear cell renal cell carcinoma in New Zealand. The trial is not yet recruiting and is uncontrolled, meaning there is no comparator arm.
RYZ512 is a unique investigational agent and no alternative names have been reported for it. It is being developed specifically as a CAIX binder for imaging in metastatic clear cell renal cell carcinoma, and it is not known to be identical to any other marketed or investigational drug.