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Also known as 89Zr-DFO-girentuximab, 89Zr-TLX250, TLX250CDx, 89Zr-DFO-TFP-girentuximab (GTX)
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 imaging agent used with PET/CT scans to detect clear cell renal cell carcinoma and urothelial carcinoma. It is designed to help identify and characterize renal masses, including indeterminate renal masses and suspected recurrent clear cell renal cell carcinoma, by targeting a protein found on those tumor cells.
89Zr-Girentuximab targets CA9, also known as carbonic anhydrase IX, a protein expressed on clear cell renal cell carcinoma cells. The antibody is labeled with zirconium-89, a positron-emitting isotope, so that binding to CA9 can be visualized on PET/CT imaging. This allows the scan to highlight tissues expressing the target.
89Zr-Girentuximab is being developed by Telix Pharmaceuticals Limited, which trades under the ticker TLX. The company is the sponsor of the clinical studies evaluating this zirconium-89 labeled girentuximab imaging agent in renal cell carcinoma and urothelial carcinoma.
89Zr-Girentuximab is in Phase 1 clinical development, with completed Phase 1 studies in renal cell carcinoma and urothelial carcinoma. A larger Phase 3 study, the ZIRCON study, has also been completed. The agent is investigational and is not described as approved for commercial use.
Completed trials include the Phase 3 ZIRCON study, NCT03849118, in clear cell renal cell carcinoma, and Phase 1 studies NCT05861778 in Chinese patients with indeterminate renal masses or suspected recurrence, NCT05046665 in urothelial carcinoma, and NCT04496089 in renal cell carcinoma in Japan. These studies enrolled a combined total of 327 participants.
Yes, 89Zr-Girentuximab is also known as 89Zr-TLX250 and 89Zr-girentuximab. The names refer to the same zirconium-89 labeled monoclonal antibody imaging agent developed by Telix Pharmaceuticals. Trial titles use both the descriptive girentuximab name and the TLX250 designation for the same product.