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Telix and Grand Pharma Announce First Patient Dosed in Phase III Kidney Cancer Trial in China

Telix & Grand Pharma dose first patient in Phase III ZIRCON-CP trial for TLX250-CDx PET imaging of kidney cancer in Beijing, China.

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  • Nov 29, 2024

  • Mrudula Kulkarni

Telix and Grand Pharma Announce First Patient Dosed in Phase III Kidney Cancer Trial in China

Telix Pharmaceuticals and Grand Pharma have reached an important milestone with the dosing and imaging of the first patient in their Phase III ZIRCON-CP trial. This trial, conducted at Beijing Cancer Hospital, is evaluating TLX250-CDx, a PET imaging agent designed to improve the detection of clear cell renal cell carcinoma (ccRCC), the most common type of kidney cancer.

ZIRCON-CP is a multi-center, Phase III registration trial in China, aimed at bridging the results of Telix’s global ZIRCON trial. The global study demonstrated high accuracy in detecting ccRCC, with 86% sensitivity, 87% specificity, and a 93% positive predictive value (PPV). The ZIRCON-CP trial, which plans to enroll up to 82 patients, seeks to confirm that TLX250-CDx performs just as well in Chinese patients as it does in Western populations.

The results from this study will play a key role in future regulatory submissions in China, where the demand for advanced diagnostic tools is growing rapidly. With an estimated 73,000 new cases of kidney cancer diagnosed annually in China, the need for accurate and early detection is critical. The increasing availability of PET/CT imaging technology further underscores the potential impact of TLX250-CDx in this market.

Dr. David N. Cade, Chief Medical Officer at Telix, emphasized the significance of the trial, saying, “Treating and imaging the first patient in ZIRCON-CP is a major step forward. We’re deeply appreciative of Professor Peng Du and his team, as well as the patients participating in this important study. Their contribution will help us move closer to bringing TLX250-CDx to patients in Greater China, where there is a significant unmet need for better kidney cancer diagnostics.”

By collaborating with Grand Pharma, Telix aims to bring this cutting-edge technology to one of the world’s largest healthcare markets, offering hope for improved outcomes for kidney cancer patients in China and beyond.

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