Telix Pharmaceuticals Limited and Grand Pharmaceutical Group Limited are pleased to announce the successful administration of the first patient dose in the Phase III ZIRCON-CP trial. This trial focuses on TLX250-CDx, an advanced PET imaging agent for clear cell renal cell carcinoma (ccRCC). The dosing and imaging procedures took place at Beijing Cancer Hospital, located in Beijing, China.
The ZIRCON-CP trial is a Phase III registration study conducted across multiple centers in China, aimed at building on the success of Telix’s global Phase III ZIRCON trial. The global trial delivered impressive results, achieving all primary and secondary endpoints with a sensitivity of 86%, specificity of 87%, and an average positive predictive value (PPV) of 93% for detecting clear cell renal cell carcinoma. In China, up to 82 patients will be enrolled to confirm that TLX250-CDx performs similarly across both Chinese and Western populations. This trial, conducted in partnership with Grand Pharma, aims to generate clinical data to support future marketing applications for this cutting-edge diagnostic technology.
The Chinese market represents a significant opportunity for radiopharmaceuticals like TLX250-CDx, driven by rising cancer incidence rates and the growing adoption of PET/CT imaging technology. Notably, kidney cancer affects approximately 73,000 new patients annually in China.
Dr. David N. Cade, Chief Medical Officer of Telix, commented:
“Telix and Grand Pharma have reached an important milestone with the successful imaging and treatment of the first patient in the ZIRCON-CP trial. We extend our gratitude to Professor Ping Dou, his team, and the patients participating in this critical study. Their contributions will play a pivotal role in advancing TLX250-CDx toward regulatory submissions in Greater China, addressing an urgent unmet medical need.”