Telix Pharmaceuticals and Grand Pharmaceutical Group have dosed the first patient in the Phase 3 ZIRCON-CP trial of TLX250-CDx for kidney cancer imaging in Chinese patients.
The late-stage trial uses TLX250-CDx as a positron emission tomography (PET) imaging agent for clear cell renal cell carcinoma (ccRCC). The first patient was dosed and imaged at Beijing Cancer Hospital in China.
TLX250-CDx (Zircaix) is an investigational PET agent being developed to noninvasively characterise indeterminate renal masses (IRMs) as ccRCC or non-ccRCC.
The ZIRCON-CP trial is a multi-centre Phase 3 registration study in China aimed at bridging to the global Phase 3 ZIRCON trial.
It met all co-primary and secondary endpoints, demonstrating 86% sensitivity, 87% specificity, and a 93% positive-predictive value (PPV) for ccRCC.
The ZIRCON-CP trial, which will enrol up to 82 patients, is designed to show that TLX250-CDx’s diagnostic utility is consistent across Chinese and Western populations. It is being conducted in collaboration with Grand Pharma, which is Telix Pharmaceuticals’ partner for the Greater China region.
The trial’s data will support future marketing authorisation applications for this PET imaging technology.
Telix Pharmaceuticals chief medical officer David Cade said: “Dosing and imaging a first patient in the ZIRCON-CP trial is a significant milestone for Telix and our partner Grand Pharma.
“We would like to thank Professor Peng Du and his team, as well as the patients who will contribute to this important trial, helping to advance TLX250-CDx towards regulatory filings in Greater China, where there is currently critical unmet medical need.”
In addition, Telix Pharmaceuticals runs programmes in the US, Europe, and Australia to provide continued access to TLX250-CDx.
The biopharmaceutical company is engaged in developing and commercialising therapeutic and diagnostic radiopharmaceuticals, as well as related medical technologies.
Based in Melbourne, Australia, the company operates internationally, including in the US, Europe, and Japan.
The biopharmaceutical company is working on a portfolio of products targeting unmet medical needs in oncology and rare diseases.
Telix Pharmaceuticals is listed on the Australian Securities Exchange and the Nasdaq Global Select Market.
Its lead imaging product, 68Ga gozetotide injection, marketed as Illuccix, has received approval from the US Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), and Health Canada.
Recently, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Eli Lilly’s flortaucipir (Tauvid) as a diagnostic imaging agent for Alzheimer’s disease patients.
