Telix Pharmaceuticals (ASX:TLX) has met the primary objectives for Part 1 of its ProstACT Global Phase 3 study.
The initial stage focused on the safety and dosimetry lead-in for TLX591-Tx, a first-in-class lutetium-177 radio antibody-drug conjugate therapy designed to treat metastatic castration-resistant prostate cancer.
The study confirmed a positive safety and tolerability profile for the drug when administered in two doses, 14 days apart, alongside standard-of-care therapies such as abiraterone, enzalutamide, or docetaxel.
Key findings indicated that hematologic events were transient and manageable, aligning with previous clinical data.
Furthermore, lesion dosimetry showed a consistent absorbed dose profile across patient cohorts, with no adverse drug-drug interactions observed.
Dr Neeraj Agarwal, the study’s Principal Investigator, noted that the results reinforce the feasibility of integrating TLX591-Tx into current treatment regimens for patients who have previously been treated with an androgen receptor pathway inhibitor.
With the safety profile established, Telix has already advanced the study into Part 2—a randomized treatment expansion—in multiple jurisdictions including Australia, Canada, and the United Kingdom.
The company intends to present this Part 1 data to the US Food and Drug Administration to seek an Investigational New Drug amendment, paved for further progression within the United States.