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ACTIVE NOT 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

2027-06

Last Updated

2026-08-13

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 (5)

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