177Lu-DOTA-TLX591 Safety, Biodistribution and Dosimetry Study

Summary

This is a Phase 1 trial of TLX591, a monoclonal antibody HuX591 conjugated with a DOTA chelator and radiolabelled with 177Lu (177Lu-DOTA-TLX591). TLX591 is being developed as a PSMA-targeting antibody to be radiolabelled with a therapeutic radiosotope for the treatment of PSMA-expressing tumours, therefore this study has been designed to assess the safety and tolerability, pharmacokinetics, whole body biodistribution and radiation dosimetry of 177Lu-DOTA-TLX591.

Timeline

Start

2022-01-30

Primary completion

2023-09-30

Completion

2023-09-30

Outcome

Met primary endpoint

release “The study achieved its primary objectives, confirming the safety and tolerability profile of TLX591 administered in two cycles,14 days apart” telixpharma.com ↗

Drugs

Indications