Study Title

telixpharmaceuticals

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

Study Details

Description:

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.

Contacts:

Nat Lenzo, MD

nat.lenzo@genesiscare.com

+61 02 8236 3300

Julie Gibson

julie.gibson@telixpharma.com

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

Locations

Not yet provided. Contact Nat Lenzo, MD for more information.

+61 02 8236 3300

nat.lenzo@genesiscare.com

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