Clinical Trial · NCT05450744

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

Overview

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

Phase

Phase 1

Contacts

Telix Medical Director

info@telixpharma.com

ClinicalTrials.gov

NCT05450744

Drug / Compound

Isotope(s):

Target(s):

Eligibility

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

Loading…