TheranosticTrials.org
Telix Pharmaceuticals

Clinical Trial · NCT04726033

A Phase I, Single Centre, Open-label Study of TLX592 to Assess the Safety and Tolerability, Pharmacokinetics, Biodistribution and Radiation Dosimetry in Patients Diagnosed With Prostate Cancer

Overview

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.

Sponsor

Telix Pharmaceuticals

Phase

Early Phase 1

Contacts

Nat Lenzo, MD

nat.lenzo@genesiscare.com

+61 02 8236 3300

Tracey Brown, PhD

tracey.brown@telixpharma.com

0412010104

ClinicalTrials.gov

NCT04726033

Drug / Compound

Isotope(s):
Target(s):

Eligibility

Inclusion

  • Histologically or cytologically confirmed diagnosis of adenocarcinoma of prostate
  • Biochemically recurrent metastatic adenocarcinoma of prostate, or metastatic primary adenocarcinoma of the prostate
  • PSMA-expressing adenocarcinoma of prostate as seen on 68Ga-PSMA-11 or 18F-DCFPyl PSMA PET/CT scanning w/in the last 1m

Exclusion

  • Previous administration of any radionuclide within 10 half-lives of 64Cu
  • Radiotherapy or immunotherapy within 4 weeks prior to the planned administration or continuing adverse effects
  • Known active brain metastases
  • Serious active infection

Patient Education

Patient education not yet provided.

Publications

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