ZIRCON Phase III Kidney Cancer Imaging Study Completes Target Enrolment

Melbourne (Australia) – 08 March 2022. Telix announces the ZIRCON Phase III study of investigational kidney cancer imaging agent, TLX250-CDx has dosed the target enrolment of 252 patients.

Telix is pleased to announce that ZIRCON (Zirconium in Renal Cancer Oncology, NCT03849118) a pivotal Phase III study of investigational renal (kidney) cancer imaging agent TLX250-CDx has dosed 252 patients, the target enrolment for the study.

TLX250-CDx (89Zr-DFO-girentuximab) is an investigational product for the imaging of clear cell renal cell carcinoma (ccRCC) with position emission tomography (PET). TLX250-CDx has received “Breakthrough Designation” from the U.S. Food and Drug Administration (FDA).

As permitted under the clinical study protocol, Telix will continue recruiting into the study for up to an additional three months. This additional recruitment will both generate further data in support of the Biologics License Application (BLA) and facilitate continued experience for trial sites ahead of Telix’s planned transition to opening a broader, more accessible Expanded Access Program (EAP). The EAP for TLX250-CDx is currently planned to commence in June 2022. Telix expects to report the outcome from the ZIRCON study in 2H, 2022.

Dr Colin Hayward, Telix’s Chief Medical Officer said, “We are pleased to have reached this important milestone in our Phase III program, and to have reached target enrolment. Recruitment into this study has accelerated as clinical sites have gradually re-opened due to COVID and investigators have become accustomed to using the imaging agent. We look forward to delivering the outcome of this highly innovative study with the goal of delivering an important unmet medical need.”

Dr Viraj Master, Director of Clinical Research, Department of Urology at Emory University School of Medicine added, “We congratulate Telix and the recruiting sites on completion of this important recruitment milestone. Clear cell renal cell carcinoma is the most common and aggressive form of kidney cancer. There is a clear need for a diagnostic tool that can aid in the management of the disease and better guide surgical decisions. In anticipation of study results, investigators at the sites have been excited by the potential utility of the agent in patients with indeterminate renal masses.”

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