Study Title

A Phase 1 Safety and Dose Finding Study of 131I -TLX101 Plus Standard of Care in Patients With Newly Diagnosed Glioblastoma

Study Details

Description:

This is an open label, single arm, parallel-group, multicentre, and dose finding study to evaluate the safety of ascending radioactive dose levels of 131I-TLX101 administered intravenously in combination with best standard of care in newly diagnosed GBM patients.

Sponsor: Telix Pharmaceuticals

Contacts:

Telix Medical Director

info@telixpharma.com

Government Study Link:

NCT05450744 - Click to see study on ClinicalTrials.gov

Inclusion

Have histologically confirmed intracranial glioblastoma following surgical resection
Plan to begin chemoradiation therapy 3-6 weeks after surgical resection with Stupp regimen
Male or female aged 18-65 years (age inclusive)
Have at least 6 slides without staining or a tissue block available for a previous biopsy or surgery
Have had prior surgery for glioblastoma but no systemic therapy or radiation therapy

Exclusion

Have had prior treatment for glioma, excluding surgery
Uncontrolled Hashimoto's or Grave's disease
Intend to be treated with tumor-treated fields prior to progression
Require chronic administration of high dose corticosteroids/other immunosuppressant drugs
Have phenylketonuria or haemostaseologic conditions

Patient Education

Patient Education Not Yet Provided

Publications

Publications Not Yet Provided

Locations

Australia

Gold Coast University Hospital

Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Austin Health

Victoria, Australia