Telix Pharmaceuticals (ASX:TLX) and St Vincent's Hospital have dosed the first patients in the phase two Optimal-e trial evaluating the investigational radioligand therapy TLX597-Tx in patients with metastatic hormone-sensitive prostate cancer, according to a Thursday statement by the company.
The open-label study is evaluating adaptive dosing of TLX597-Tx in combination with androgen deprivation therapy and an androgen receptor pathway inhibitor using PSMA-PET imaging and prostate-specific antigen (PSA) levels to personalize treatment according to each patient's response.
The study will evaluate the impact of TLX597-Tx on PSA response rate, depth, and durability in an earlier treatment setting while further assessing the safety of dose intensification.
TLX597-Tx is an investigational therapy that has not received marketing approval in any jurisdiction, the company added.