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89Zr-Girentuximab · 4 trials · 5 indications
This outcome was evaluated on all patients by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This was compared against the histological determination of the lesion type following resection of the lesion
Sensitivity and specificity will be established following histological confirmation
Frequency of occurrence and severity of abnormal findings in safety investigations regarding the physical examination.
Frequency of occurrence and severity of abnormal findings in safety investigations regarding the Vital signs
Frequency of occurrence and severity of abnormal findings in safety investigations regarding Laboratory examinations.
Frequency of occurrence and severity of abnormal findings in safety investigations regarding concomitant medications.
Frequency of occurrence and severity of abnormal findings in the 12-lead ECG (ECG QT Interval)
Incidence of abnormal laboratory test results and abnormal vital signs
The sensitivity and specificity of 89Zr-TLX250 to detect renal cell carcinoma will be established by a diagnostic scan after administration of the investigational product followed by surgery of the indeterminate mass. After surgical removal of the kidney mass , diagnostic histology of the mass will be conducted and used as the "standard of truth" comparator.
| Arm | Type | Description |
|---|---|---|
| 89Zr-girentuximab | EXPERIMENTAL | A single administration of 37 Megabecquerel (MBq) (±10%) 89Zr-girentuximab, containing a mass dose of 10 mg of girentuximab, followed by a diagnostic scan on Day 5 ± 2 days after administration. |
| Administration of 89Zr-Girentuximab | OTHER | Administration of 89Zr-Girentuximab as per protocol |
| Name | Type | Description |
|---|---|---|
| 89Zr-girentuximab | DIAGNOSTIC_TEST | Single IV administration on Day 0, followed by diagnostic scan on Day 5 +/- 2 days. |
Inclusion Criteria: 1. Written and voluntarily given Informed Consent 2. Male or female ≥18 years of age 3. Imaging evidence of a single indeterminate renal mass of ≤7cm in largest diameter (tumour stage cT1) , on CT or MRI with and without contrast agent, suspicious for ccRCC 4. Scheduled for lesi...
89Zr-Girentuximab is an investigational PET imaging agent being developed by Telix Pharmaceuticals Limited for use in oncology. It is designed to help visualize certain cancers, including clear cell renal cell carcinoma and urothelial carcinoma, during PET/CT imaging procedures. It combines the radionuclide zirconium-89 with the antibody girentuximab.
89Zr-Girentuximab targets CA9, also known as carbonic anhydrase IX. CA9 is a protein frequently expressed in clear cell renal cell carcinoma and other tumor types. By binding CA9, the zirconium-89 labeled antibody allows PET imaging to detect cells expressing this target, supporting diagnostic evaluation of renal masses and urothelial carcinoma.
Telix Pharmaceuticals Limited is developing 89Zr-Girentuximab. Telix Pharmaceuticals trades under the ticker TLX. The company is advancing the agent as a PET/CT imaging product for oncology indications, including clear cell renal cell carcinoma and urothelial carcinoma.
89Zr-Girentuximab is in clinical development, with Phase 1 studies completed. It is investigational and has not been approved by the FDA. A larger Phase 3 study, the ZIRCON study, has also been completed. The program includes completed trials in renal cell carcinoma and urothelial carcinoma.
Completed clinical trials of 89Zr-Girentuximab include NCT03849118, the Phase 3 ZIRCON study in clear cell renal cell carcinoma, and Phase 1 studies NCT05861778 in Chinese patients with indeterminate renal masses or suspected recurrent clear cell renal cell carcinoma, NCT05046665 in urothelial carcinoma, and NCT04496089 in renal cell carcinoma in Japan.
89Zr-Girentuximab is being studied for PET/CT imaging in oncology, specifically for clear cell renal cell carcinoma and urothelial carcinoma. It is intended to help evaluate indeterminate renal masses and suspected recurrent disease. It is an investigational imaging agent and is not approved for clinical use.