Telix Pharmaceuticals Limited (ASX: TLX) has received positive preliminary results from the Phase I ProstACT SELECT study of its rADC therapy candidate TLX591 for prostate- specific membrane antigen (PSMA) positive metastatic castration-resistant prostate cancer (mCRPC).
The purpose of the SELECT study was to evaluate the utility of PSMA imaging to select patients for rADC-based PSMA therapy and to confirm the biodistribution of the rADC investigational therapy. The primary clinical objective was to determine whole body distribution and organ radiation and assess the safety and tolerability of TLX591, when administered in combination with SoC in second-line mCRPC.
The evaluable population was 28 patients (of a total 30 enrolled in the study). Patients received two single intravenous (IV) infusions of TLX591, 14 days apart.
The study achieved its primary objectives, confirming the safety and tolerability profile of TLX591 administered in two cycles,14 days apart (total cumulative dose 152mCi). The results reinforce the clinical utility of the short, fractionated dosing regimen.
TLX591 is being designed to integrate with current standard of care, demonstrative of Telix’s continued innovation in prostate cancer treatment. The SELECT study provides further validation of the potential of TLX591, a first-in-class rADC therapy and the use of PSMA imaging with small molecules to select patients for antibody-based PSMA therapy,” Colin Hayward, Telix Chief Medical Officer, said.
