Clinical Trial: NCT04786847
177Lu-DOTA-TLX591 Safety, Biodistribution and Dosimetry Study
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | Telix Pharmaceuticals (Innovations) Pty Limited |
| Information Provided By: | Telix Pharmaceuticals (Innovations) Pty Limited |
| Last Update Posted: | 2024-02-12 |
Study Overview
Brief Summary
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.
Official Title
Conditions
Intervention / Treatment
- Biological: 177Lu-DOTA-TLX591
Other Study ID Numbers
- 177Lu-TLX591-001
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Telix Pharmaceuticals (Innovations) Pty Limited |
| Information Provided By: | Telix Pharmaceuticals (Innovations) Pty Limited |
| Last Update Posted: | 2024-02-12 |
Study Overview
Brief Summary
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.
Official Title
Conditions
Intervention / Treatment
- Biological: 177Lu-DOTA-TLX591
Other Study ID Numbers
- 177Lu-TLX591-001