Telix’s Phase 3 ProstACT Part 1 Meets Safety Objectives in 36-Patient Trial
Part 1 of Telix's global Phase 3 ProstACT trial dosed 36 mCRPC patients across three standard-of-care cohorts and met primary safety and dosimetry objectives with no new safety signals and manageable hematologic events. The company has advanced to Part 2 expansion and will seek an FDA IND amendment to support global trial progression.
1. Part 1 safety and dosimetry objectives met
Telix’s lead-in cohort of the Phase 3 ProstACT trial dosed 36 mCRPC patients in three standard-of-care combination regimens with TLX591-Tx administered in two doses 14 days apart. The study showed an acceptable safety profile, no new safety signals, and manageable hematologic events aligning with prior studies.
2. Dosing cohorts and adverse event profile
Patients received TLX591-Tx plus enzalutamide (11 patients), abiraterone (11 patients) or docetaxel (14 patients). Non-hematologic events were predominantly Grade 1/2 (fatigue 53%, nausea 28%, dry mouth 25%), while transient Grade 3/4 hematologic events matched expectations.
3. Advancement to Part 2 and regulatory plans
Based on these results, Telix is initiating Part 2 with a 2:1 randomized expansion targeting approximately 490 patients and will present Part 1 data to the FDA for an IND amendment to support U.S. trial progression.