RecruitingPhase 1NCT05450744

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


Sponsor

Telix Pharmaceuticals (Innovations) Pty Limited

Enrollment

12 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a radioactive drug called 131I-TLX-101 (iobenguane I-131) in people with newly diagnosed glioblastoma — an aggressive brain cancer. The drug is designed to deliver targeted radiation directly to brain tumor cells. This is a Phase 2 study evaluating how well the treatment works. **You may be eligible if...** - You have been newly diagnosed with glioblastoma (a type of aggressive brain tumor) - You have completed or are completing standard initial treatment (surgery and/or radiation with temozolomide chemotherapy) - You are 18 years or older - Your tumor shows certain features that the drug can target - Your general health is good enough to participate (adequate organ function) **You may NOT be eligible if...** - Your cancer has already progressed or recurred - You have received prior treatment with this type of radioactive drug - You have severe organ problems (kidney, liver, bone marrow) - You are pregnant or breastfeeding - You are unable to follow radiation safety precautions after dosing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG131I-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

View Full Details on ClinicalTrials.gov

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NCT05450744


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