drugset
drugset / Trial / NCT04726033

64Cu-TLX592 Phase I Safety, PK, Biodistribution and Dosimetry Study (CUPID Study)

NCT04726033 ↗

Phase 0 Completed 14 enrolled Telix Pharmaceuticals (Innovations) Pty Limited
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 1 trial of TLX592, a humanised, engineered monoclonal antibody HuX592r conjugated with a DOTA chelator and radiolabelled with 64Cu (64Cu-TLX592). TLX592 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 64Cu-TLX592.

Timeline

Start
2021-08-04
Primary completion
2023-12-30
Completion
2024-01-29

Drugs

EvaluationDrugModalityDoseRoute
Subject 64Cu-DOTA-TLX592 Monoclonal antibody 2 mg Intravenous
Subject 64Cu-DOTA-TLX592 Monoclonal antibody 10 mg Intravenous
Subject 64Cu-DOTA-TLX592 Monoclonal antibody 20 mg Intravenous
Subject 64Cu-DOTA-TLX592 Monoclonal antibody 300 mbq Intravenous

Indications

metastatic prostate carcinoma