NCT05450744

131I-TLX-101 for Treatment of Newly Diagnosed Glioblastoma (IPAX-2)

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Neoplastic Disease
• Glioblastoma
• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	131I-IPA	131I-IPA: injection/solution administrated intravenously via infusion in ascending doses 18F-FET: injection/solution administrated intravenously

Timeline

• Start date: 2023-04-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2022-07-11
• Last updated: 2026-01-21

Locations

6 sites across 3 countries: Australia, Austria, Netherlands