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

RECRUITINGPHASE3

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])

NCT07100730•Telix Pharmaceuticals (Innovations) Pty Limited

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Previously confirmed neuropathological diagnosis of glioblastoma, IDH-wildtype according to the WHO 2021 classification.
•2. Radiographic evidence of first recurrence or progressive glioblastoma according to RANO 2.0 criteria after first-line treatment with biopsy or maximal safe resection and standard radiotherapy or chemoradiotherapy having occurred at least 3 months after the end of prior radiotherapy. Prior first-line therapy may include a combination of:
•1. Any systemic antineoplastic treatment other than nitroureas
•2. Tumor-treating fields
•3. Conventionally fractionated or abbreviated (minimum 15 fractions) radiotherapy
•3. Increased \[18F\]\]FET PET tracer uptake inside or in the vicinity of tumor. Specifically, amino acid-based molecular imaging using \[18F\]FET PET will be evaluated following co-registration with MRI. The allocated physician/reader will assess whether the observed pathologically increased amino acid uptake is located within the tumor or in the vicinity. This determination will serve as a guidance to confirm whether the uptake is tumor-associated. The uptake must be clearly discernible from background activity and measurable per PET RANO 1.0 criteria, as determined by central review.
•4. Tumor debulking for recurrent, progressive disease is allowed. The patient must have post-surgical (4-6 weeks) radiographic evidence for residual tumor according to RANO 2.0 with increased \[18F\] FET PET uptake and measurable disease according to PET RANO 1.0.
•5. 18 years or older
•6. Have the capacity to understand the study and be willing to comply with all protocol requirements.
•7. Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 or KPS≥70
+4 more criteria

Exclusion Criteria

•1. Prior course with external beam radiation to the brain in the past 3 months. Prior treatment with brachytherapy in the brain.
•2. Treatment with bevacizumab within the prior 6 weeks.
•3. Known contraindication to imaging tracer or any product of contrast media and MRI contraindications including implanted medical devices. Unable to lie still for at least 20 min or the duration of the MRI and PET imaging or the need for general anesthesia as part of the imaging procedure.
•4. History or evidence of delayed-type hypersensitivity-dependent chronic infection (ie, tuberculosis, systemic fungal or parasitic infection).
•5. Radiographic progression based on RANO 2.0 associated with clinical deterioration and life expectancy less than 3 months.
•6. Hemostaseologic conditions, precluding catheterization or invasive procedures.
•7. Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product.
•8. Known liver or kidney disease, such as hepatitis, cirrhosis, renal failure.
•9. Severe chronic or active infections (including active tuberculosis, hepatitis B virus, or hepatitis C virus infection) requiring systemic therapy.
•10. Ongoing toxicity \> Grade 2 NCI-CTCAE (version 5.0) from previous standard or investigational therapies.
+5 more criteria

Locations (4)

Gold Coast University Hospital

Gold Coast, Queensland, Australia

Austin Health

Melbourne, Australia

Johannes Kepler University

Linz, Austria

UMC Utrecht

Utrecht, Netherlands

Key Dates

Start Date

November 2, 2025

Primary Completion Date

July 1, 2027

Completion Date

November 1, 2027

Last Updated

March 12, 2026

Enrollment

ESTIMATED participants

Conditions

Neoplastic DiseaseGlioblastomaGlioblastoma (GBM)Glioblastoma MultiformGlioblastoma Multiforme, AdultGlioblastoma Multiforme (GBM) WHO Grade IV

Interventions

TLX-101-Tx + Lomustine

COMBINATION_PRODUCT

TLX101-Tx

RADIATION

Contacts

Clinical Project Manager

CONTACT

2154902000 samuel.park@telixpharma.com

Back-up Clinical Project Manager

CONTACT

neil.smith@telixpharma.com

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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RECRUITING

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

NCT00083512

Glioblastoma Multiforme

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

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