Telix Doses First Patient in Phase 3 IPAX-BrIGHT Trial of TLX101-Tx for Recurrent Glioblastoma
Melbourne (Australia), Indianapolis, IN (U.S.) | April 15, 2026
Telix today announces that the first patient has been dosed with TLX101-Tx (¹³¹I-iodofalan) in Telix’s pivotal IPAX BrIGHT trial[1], marking the first radiopharmaceutical therapy to enter Phase 3 development for glioblastoma, an aggressive form of brain cancer.
The patient was dosed at Austin Health in Melbourne, Australia, under the supervision of Professor Hui Gan. IPAX BrIGHT is assessing the safety and efficacy of TLX101-Tx in combination with chemotherapy (lomustine), compared to chemotherapy alone. The global, multicenter, open-label study will enroll patients with radiographically confirmed recurrent glioblastoma at first recurrence.
Telix’s commitment to advancing care for patients with glioblastoma is driven by the significant unmet need in this space. In the past 25 years, only two drugs have been approved by the United States Food and Drug Administration (FDA) for glioblastoma[2], and no standard treatment currently exists for recurrent disease. Patients therefore face limited treatment options after initial therapy. TLX101-Tx offers a novel approach by targeting the L-type amino acid transporter 1 (LAT1), a transporter that enables the radiopharmaceutical to cross the blood-brain barrier and delivers therapy directly to the tumor.
IPAX BrIGHT expands upon promising data from earlier trials in the recurrent glioblastoma setting, including IPAX-1[3], which reported a median overall survival (OS) of 13 months from the initiation of treatment with TLX101-Tx, or 23 months from initial diagnosis[4]. Preliminary results from the IPAX-Linz investigator-initiated trial of TLX101-Tx were consistent and confirmatory to IPAX-1, with a median OS of 12.4 months from initiation of treatment and 32.2 months from initial diagnosis[5]. Beyond the clinical trial setting, an early access program for TLX101-Tx in Europe has dosed 18 patients at first recurrence or later, further establishing the clinical utility of TLX101-Tx.
Professor Gan, Director of Cancer Clinical Trials at Austin Health, said, “Based on the prior safety profile and early efficacy data for TLX101-Tx in the IPAX-1 and IPAX-Linz studies, I am pleased to continue to explore this therapeutic modality in the first radiopharmaceutical pivotal trial in recurrent glioblastoma, where there are currently few effective treatment options.”
Dr. David N. Cade, Group Chief Medical Officer, Telix, added, “Through the IPAX BrIGHT trial, we aim to offer a new option for patients affected by glioblastoma. This registration-enabling study represents a major step forward in our mission to improve therapeutic options in neuro-oncology. With very limited innovation in treatment in recent decades, TLX101-Tx has the potential to become a first-in-class therapy that meaningfully improves patient outcomes.”
The IPAX BrIGHT study has received regulatory approval in Australia, Austria, Belgium and the Netherlands with approval being sought in additional jurisdictions. Telix’s investigational PET[6] imaging agent for glioma, TLX101-Px (floretyrosine F 18) will be used for patient selection in IPAX BrIGHT, as well as assessing metabolic tumor response according to PET RANO 1.0[7].
TLX101-Tx and TLX101-Px have not received a marketing authorization in any jurisdiction
[1] ClinicalTrials.gov ID: NCT07100730.
[2] Temozolomide approved in 2005 and Bevacizumab in 2009.
[3] ClinicalTrials.gov ID: NCT03849105.
[4] Pichler et al. Neurooncol Adv. 2024. https://doi.org/10.1093/noajnl/vdae130
[5] Telix ASX disclosure April 16, 2025. Date presented by Professor Josef Pichler at the Nuclear Medicine and Neurooncology (NMN) Symposium in Vienna (Austria), May 2025.
[6] Positron emission tomography.
[7] Response Assessment in Neurooncology practice guidelines for the clinical use of PET imaging in gliomas.