RecruitingPhase 3NCT07100730

Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma

A Global, Multicenter, Prospective, Controlled, Open-Label Pivotal Study of Iodofalan (131I) Solution for Injection (TLX101-Tx) Plus Lomustine Versus Lomustine Alone in Patients With Radiographically Confirmed Recurrent Glioblastoma at First Recurrence (IPAX BrIGHT [IPAX-3])


Sponsor

Telix Pharmaceuticals (Innovations) Pty Limited

Enrollment

50 participants

Start Date

Nov 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This global clinical trial which evaluates the efficacy and safety of TLX101-Tx, an investigational radiopharmaceutical therapy, in combination with lomustine versus lomustine alone in adult patients with first recurrence of glioblastoma. TLX101-Tx delivers targeted radiation to glioblastoma cells. The trial is conducted in two parts: Part 1 assesses safety and radiation dosing; Part 2 is a randomized comparison of the combination therapy against standard care.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a targeted radiation therapy called TLX101-Tx (which uses a radioactive amino acid to seek out and irradiate brain tumor cells from the inside) combined with standard treatment for people whose glioblastoma — the most aggressive type of brain tumor — has come back for the first time after initial treatment. **You may be eligible if...** - You are 18 or older - You have glioblastoma that has been confirmed to have returned after first-line treatment - Your tumor is visible on both MRI and a specific amino acid PET scan (FET-PET) - Your general health is adequate (ECOG 0–2 or KPS ≥70) - You had your first-line treatment (surgery and radiotherapy) at least 3 months ago - Your blood, liver, and kidney function are adequate **You may NOT be eligible if...** - You had brain radiation within the past 3 months - You received bevacizumab within the past 6 weeks - You have an implanted device that is incompatible with MRI or PET scans - You have active severe infection (tuberculosis, hepatitis B or C) - You have phenylketonuria (a metabolic condition that affects amino acid processing) - You have ongoing grade 2 or higher side effects from your previous treatment - You have participated in another experimental study within 90 days 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

COMBINATION_PRODUCTTLX-101-Tx + Lomustine

Combination therapy with TLX-101-Tx + Lomustine

RADIATIONTLX101-Tx

TLX101-Tx


Locations(4)

Gold Coast University Hospital

Gold Coast, Queensland, Australia

Austin Health

Melbourne, Australia

Johannes Kepler University

Linz, Austria

UMC Utrecht

Utrecht, Netherlands

View Full Details on ClinicalTrials.gov

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NCT07100730


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