Study Title

telixpharmaceuticals

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.

Contacts:

Telix Medical Director

info@telixpharma.com

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

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