Telix Pharmaceuticals (ASX:TLX) says it has been granted Human Research Ethics Committee (HREC) approval and received Clinical Trial Notification (CTN) clearance by the TGA for a phase 3 clinical trial of its PSMA targeted prostate cancer therapy candidate TLX591 (177Lu-DOTA-rosopatamab).
The company said the ProstACT trial is an international, multi-centre, randomised controlled trial in patients with PSMA-expressing mCRPC, experiencing disease progression following prior treatment with a novel androgen axis drug (NAAD).
The trial will enrol approximately 390 patients and incorporates patient selection using 68Ga-PSMA imaging with TLX591-CDx (Illuccix). It will compare standard of care therapy alone versus standard of care therapy plus TLX591, with a primary endpoint of radiographic progression-free survival (rPFS).
The company said trial secondary endpoints will include overall survival and quality-of-life assessment.
Telix has commenced the initiation of Australian trial sites and will add global sites progressively during the second half of 2021, subject to the requisite approvals.
According to CEO Dr Christian Behrenbruch, “The commencement of the ProstACT Phase III study for TLX591 marks a major corporate milestone for Telix that brings the Company a step closer to delivering on a major unmet medical need for treatment options in this patient population.
"ProstACT builds on a significant body of clinical data for TLX591, which to date has been studied in over 200 patients with advanced prostate cancer, across five previous studies. TLX591 has demonstrated promising and competitive clinical potential that we believe warrants further confirmation in this second-line disease setting.
"It is also noteworthy that Telix’s differentiated approach to integrating molecular imaging with PET alongside therapy, enables a comparatively streamlined study that we believe will support efficient patient enrolment and study execution.”