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RECRUITING
NCT05450744
PHASE1

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

Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2023-04-01

Completion Date

2026-06

Last Updated

2026-01-21

Healthy Volunteers

No

Interventions

DRUG

131I-IPA

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

Locations (6)

Royal North Shore Hospital

Sydney, New South Wales, Australia

Gold Coast University Hospital

Gold Coast, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Olivia Newton John Cancer Research Institute/Austin Health

Melbourne, Victoria, Australia

Institut für Nuklearmedizin und Endokrinologie

Linz, Austria

UNMC Utrecht

Utrecht, Netherlands