Telix Pharmaceuticals Limited announces that the first patient has been dosed in a Phase II trial exploring the clinical utility of Telix's first-in-class investigational PET^[1] agent, TLX250-CDx (⁸⁹Zr-girentuximab) in recurrent clear cell renal cell carcinoma (ccRCC) after surgery.

'CA-NINE'^[2] – led by Professor Brian Shuch at University of California, Los Angeles (UCLA) – is a Phase II prospective, single-centre trial comparing the diagnostic performance of TLX250-CDx PET/CT^[3] to conventional imaging (contrast-enhanced CT alone) in 91 patients with intermediate-to-high risk ccRCC post-surgery. The investigator-initiated trial is designed to identify ccRCC where it has recurred, including metastatic disease, and is one of multiple trials either underway or planned, which may inform future label expansion for TLX250-CDx.

Professor Brian Shuch, MD, Director of the Kidney Cancer Program and the Alvin & Carrie Meinhardt Endowed Chair in Kidney Cancer Research at UCLA Institute of Urologic Oncology, and Principal Investigator on the CA-NINE trial, said, "Telix's ZIRCON trial demonstrated the accuracy of TLX250-CDx at diagnosing localised ccRCC. However, we know that many patients die of metastatic disease, where the cancer has spread. There are plenty of data showing that metastatic ccRCC also expresses the carbonic anhydrase IX (CAIX) biomarker, which demonstrates potential use beyond localised ccRCC. We are on the cusp of a revolution in how we detect and manage advanced kidney cancer before and after surgery, and I'm excited to work with Telix to hopefully bring this technology to patients should it receive regulatory approval."

Associate Professor Jeremie Calais, MD, Director of the Theranostics Program of the Ahmanson Translational Theranostics Division of the Department of Molecular and Medical Pharmacology at UCLA School of Medicine, and an investigator on the CA-NINE trial, added, "With TLX250-CDx it is exciting that we can now characterise indeterminate renal masses with greater confidence. However, this only scratches the surface of the clinical potential of this investigational agent. With conventional imaging, we are very limited in our ability to stage patients, and we are hopeful that this investigational agent will improve patient outcomes by shedding light on sites of recurrent ccRCC outside of the kidney."

Dr David N. Cade, Chief Medical Officer at Telix continued, "We are pleased that a first patient has been imaged in the CA-NINE trial, which supports potential label expansion for TLX250-CDx into recurrent, metastatic disease. We would like to thank Professor Shuch and Associate Professor Calais at UCLA for their commitment to addressing unmet medical need in kidney cancer, as well as the patients who will contribute to this important trial."