Telix today revealed that the first patient has been dosed in China in the pivotal Phase III registration study of TLX591-CDx (Illuccix, Kit for the preparation of Ga-PSMA-11), for the imaging of prostate cancer using positron emission tomography (PET).
The Phase III Illuccix China study (ClinicalTrials.gov ID: NCT05847348) is a prospective, open-label, single-arm, multicenter study in Chinese patients with biochemically recurrent (BCR) prostate cancer that is intended to bridge to the marketing authorisation granted to Illuccix by the United States Food and Drug Administration (FDA). The study – a collaboration with Telix’s strategic partner for the Greater China region, Grand Pharmaceutical Group Limited (Grand Pharma) – is required to establish that the diagnostic utility of TLX591-CDx is equivalent in Chinese and Western populations. This study will enrol up to 110 patients with BCR prostate cancer, and data will support a future marketing authorisation application for TLX591-CDx in China.
Dr Shams UL Arifeen, Regional Medical Director, Telix Asia Pacific said, “We are pleased to have commenced this study, which brings advanced PSMA-PET imaging one step closer for Chinese men with prostate cancer. With our strategic collaborator in the region, Grand Pharma, we would like to express our gratitude to Dr Yong He, principal investigator at Zhongnan Hospital of Wuhan University as well as his clinical research team, and the patients who will contribute to this important study.”