Study Title
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
Study Details
Description:
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 PharmaceuticalsContacts:
Nat Lenzo, MDnat.lenzo@genesiscare.com
+61 02 8236 3300
Tracey Brown, PhDtracey.brown@telixpharma.com
0412010104
Government Study Link:
NCT04726033 - Click here to see study onClinicalTrials.gov
- 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
- 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
Locations
Not yet provided. Contact Nat Lenzo, MD for more information.
+61 02 8236 3300
nat.lenzo@genesiscare.com
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