Telix Pharmaceuticals (ASX:TLX) said part two of its ProstACT global study evaluating its radiopharmaceutical candidate, TLX591, for the potential treatment of patients with metastatic castration resistant prostate cancer (mCRPC) is enrolling patients in Australia, Canada, and New Zealand, following Independent Data Monitoring Committee (IDMC) review, according to a Friday statement.
The trial design includes an option to combine TLX591-Tx in mCRPC with either abiraterone, enzalutamide, or docetaxel. TLX591-Tx is a radio antibody-drug conjugate for mCRPC expressing prostate-specific membrane antigen.
Its dose expansion trials showed that a fractionated dosing regimen managed hematologic safety while delivering a targeted radiation dose. The trial established an efficacy signal, demonstrating its anti-tumor effect and overall survival benefit of monotherapy in mCRPC.
Its ProstACT SELECT trial confirmed the safety and tolerability profile of the drug candidate in combination with standard-of-care, with 23 of 25 participants administered two doses of 76 millicurie.