Telix Pharmaceuticals Limited (ASX: TLX) reports that the first patients have been dosed in the Phase III ZIRCONclinical trial of Telix’s renal cancer diagnostic imaging product TLX250- CDx (89Zr-girentuximab) in the United States.
The objective of the ZIRCON trial is to evaluate the sensitivity and specificity of PET/CT imaging with TLX250-CDx to non-invasively detect clear cell renal cell carcinoma (ccRCC) in patients with indeterminate renal masses in comparison with surgical resection (histology), as the standard of truth.
Chief Medical Officer, Dr Colin Hayward, said the ZIRCON trial, which includes 12 participating clinical study sites across the U.S. and Canada, initiated patient recruitment in U.S. on Friday, with the first patients being dosed with TLX250-CDx at University of California, Los Angeles (UCLA), and Seattle Cancer Care Alliance, University of Washington, Seattle (SCCA). The remaining seven U.S. sites and three sites in Canada are expected to commence patient recruitment progressively over the next month.
We are pleased to have commenced the Phase III ZIRCON clinical trial in North America and wish to express our gratitude to Prof. Allan Pantuck and Dr Delphine Chen, principal investigators at UCLA and SCCA, respectively, as well as their clinical research teams and patients, who have made this important milestone possible,” Dr Hayward said.
ZIRCON (Zirconium Imaging in Renal Cancer Oncology) is an international multi-centre Phase III study at 36 sites in Europe, Australia, Turkey, Canada, and the United States (subject to regulatory approval in the various jurisdictions).
ZIRCON is a prospective imaging trial in approximately 250 renal cancer patients undergoing kidney surgery, to determine the sensitivity and specificity of TLX250-CDx PET imaging to detect clear cell renal cell cancer (ccRCC) in comparison with histologic “ground truth” determined from surgical resection specimens.
About TLX250-CDx
TLX250-CDx (89Zr-girentuximab) is being developed by Telix for the purpose of determining whether “indeterminate renal masses”, typically identified based on CT or MRI imaging, are either clear cell renal cell cancer (ccRCC) or non-ccRCC, using Positron Emission Tomography (PET) imaging.
Girentuximab is a monoclonal antibody that targets carbonic anhydrase IX (CAIX), a cell surface target that is highly expressed in several human cancers including renal, lung and oesophageal cancers.
In July 2020, the US Food and Drug Administration (FDA) granted Breakthrough Therapy (BT) designation for TLX250-CDx, reflecting the significant unmet clinical need to improve the diagnosis and staging of ccRCC, the most common and aggressive form of kidney cancer.