Telix Pharmaceuticals Limited and Grand Pharmaceutical Group Limited have announced the dosing of the first patient in the Phase III ZIRCON-CP trial of TLX250-CDx, a positron emission tomography (PET) imaging agent, for clear cell renal cell carcinoma (ccRCC). The patient was dosed and imaged at Beijing Cancer Hospital in Beijing, China.
ZIRCON-CP Trial Details
The ZIRCON-CP trial is a multi-center Phase III registration trial in China designed to align with Telix's global Phase III ZIRCON trial. The global trial met all co-primary and secondary endpoints, demonstrating 86% sensitivity and 87% specificity, with a 93% mean positive-predictive value (PPV) for ccRCC. The ZIRCON-CP trial will enroll up to 82 patients and aims to confirm that TLX250-CDx's diagnostic capabilities are consistent between Chinese and Western populations. Data from this trial will support future marketing authorization applications.
Market Opportunity
Greater China represents a significant market for radiopharmaceuticals due to rising cancer rates and investments in PET/CT technology. In China, approximately 73,000 new kidney cancer cases are diagnosed annually.
Expert Commentary
Dr. David N. Cade, Chief Medical Officer at Telix, stated, "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."
About TLX250-CDx
TLX250-CDx (Zircaix) is an investigational PET agent developed to characterize indeterminate renal masses (IRMs) as either ccRCC or non-ccRCC non-invasively. In the pivotal Phase III ZIRCON trial (NCT03849118), TLX250-CDx demonstrated high accuracy and consistency in detecting the clear cell phenotype, offering a reliable, non-invasive diagnostic method for ccRCC.
Continued Access Programs
Telix continues to offer access to TLX250-CDx outside of clinical trials through an expanded access program (EAP) in the U.S., named patient programs (NPPs) in Europe, and a special access scheme (SAS) in Australia, for patients lacking comparable alternative options.
