Telix (ASX:TLX) has announced that its ZIRCON Phase 3 study of investigational kidney cancer imaging agent, TLX250-CDx, has dosed the target enrolment of 252 patients.
TLX250-CDx (89Zr-DFO-girentuximab) is an investigational product for the imaging of clear cell renal cell carcinoma (ccRCC) with position emission tomography (PET). It has received “Breakthrough Designation” from the US FDA.
Telix said it 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)," said the company, adding, "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."
Telix chief medical officer Dr Colin Hayward 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.”