TheranosticTrials.org
Telix Pharmaceuticals

Clinical Trial · NCT04786847

A Phase 1 Safety, Tolerability, Biodistribution, Dosimetry and Efficacy Study of 177Lu-DOTA-TLX591 With Best Standard of Care in Patients With PSMA Expressing Metastatic Castration-resistant Prostate Cancer

Overview

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.

Sponsor

Telix Pharmaceuticals

Phase

Phase 1

Contacts

Nat Lenzo, MD

nat.lenzo@genesiscare.com

+61 02 8236 3300

Julie Gibson

julie.gibson@telixpharma.com

ClinicalTrials.gov

NCT04786847

Drug / Compound

Isotope(s):
Target(s):

Eligibility

Inclusion

  • Must have received minimum 12w prior therapy with no more than one NAAD (enzalutamide and/or abiraterone + prednisone)
  • Male, at least 18 years old, with metastatic adenocarcinoma of the prostate defined by histology/pathology
  • Have PSMA-positive disease as demonstrated by 68Ga-PSMA-11 PET/CT scan
  • Must have received one line of prior taxane therapy in the hormone sensitive setting
  • Have disease that is progressing, despite a castrate testosterone level

Exclusion

  • Have received prior treatment of monoclonal antibody (mAb) J591 or HuJ591 or any other PSMA targeted therapy
  • At increased risk of hemorrhage or using long-term anti-coagulant or anti-platelet agents (except low dose aspirin)
  • Have received prior systemic anti-cancer therapy and/or radiation within 4w of enrollment
  • Have known brain metastases (any size) or hepatic metastases > 1 cm
  • Have PC associated with findings consistent with small cell or any histology other than adenocarcinoma of the prostate

Patient Education

Patient education not yet provided.

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