MELBOURNE, Australia , Oct. 4, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today 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 ( 89 Zr-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.
