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A Phase 1 Safety and Dose Finding Study of 131I -TLX101 Plus Standard of Care in Patients With Newly Diagnosed Glioblastoma
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 PharmaceuticalsContacts:
Telix Medical Directorinfo@telixpharma.com
Government Study Link:
NCT05450744 - Click here to see study onClinicalTrials.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
Austria 🇦🇹
Kepler University Hospital
Linz, Upper Austria, Austria
Netherlands 🇳🇱
UMC Utrecht
Utrecht, Utrecht, Netherlands
New Zealand 🇳🇿
Mercy Hospital
Auckland, Auckland, New Zealand
