The first patient has been dosed in a Phase I/II study of Telix Pharmaceuticals Limited’s (ASX: TLX) renal cancer diagnostic imaging product TLX250-CDx (Zr-girentuximab) in Japan.
Telix Pharmaceuticals Japan K.K. President, Dr Shintaro Nishimura, said the objective of the study, termed the “ZIRDAC-JP” (Zirconium Dosing and Comparison in Japan) study is to confirm the safety and tolerability, as well as sensitivity and specificity of positron emission tomography (PET) imaging with TLX250-CDx to detect clear cell renal cell cancer (ccRCC) in Japanese patients.
The patient population for the ZIRDAC-JP trial has been selected to be identical to the global Phase III ZIRCON trial, with comparison to surgical resection (histology) as standard of truth.
Dr Nishimura said the study has been carefully designed in consultation with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to collect the necessary data to potentially bridge to the ZIRCON study by confirming that dosing and pharmacology in Japanese patients is consistent with the rest- of-world experience.
The ZIRDAC-JP study is the first commercially sponsored clinical trial in Japan in which a zirconium-based diagnostic agent has been studied,” Dr Nishimura said.
“Dosing the first patient in the ZIRDAC-JP study represents a significant first step for the Japanese nuclear medicine community to deliver benefit to Japanese cancer patients and to pave the way for the future use of theranostics in Japan.
“We’d like to express our appreciation to Dr Nakaigawa, the study’s principal investigator at Yokohama City University Hospital, the investigators and the study team for their excellent collaboration, and most importantly the patients who will participate in this trial.”
ZIRDAC-JP (Zirconium Dosing and Comparison in Japan, NCT04496089) is a Japanese multi- centre Phase I/II study that will recruit approximately 40 patients in total.
The objectives of the study are to determine the safety, tolerability, radiation dosimetry and pharmacokinetics / pharmacodynamics (Phase I), and the sensitivity and specificity of TLX250-CDx PET imaging to detect clear cell renal cell cancer (ccRCC) compared to histologic ‘ground truth’ determined from surgical resection specimens (Phase II).