Telix doses first patient in phase 3 glioblastoma trial

Telix Pharmaceuticals has dosed the first patient in its phase 3 IPAX BrIGHT trial of TLX101-Tx, also known as iodine-131 iodofalan, for recurrent glioblastoma. Telix said it is the first radiopharmaceutical therapy to enter phase 3 development for the disease.

Austin Health in Melbourne, Australia, dosed the first patient under the supervision of Hui Gan, MD. IPAX BrIGHT is a global, multicenter, open-label study evaluating TLX101-Tx with lomustine compared with lomustine alone.

Eligible patients have radiographically confirmed recurrent glioblastoma at first recurrence. The Victorian Cancer Trials Link lists the study as recruiting and describes the trial as evaluating safety and efficacy in people with first recurrence of glioblastoma.

Telix’s investigational PET imaging agent TLX101-Px, also known as Pixclara, will be used for patient selection and metabolic tumor response assessment in the trial. The company said response will be assessed according to PET RANO 1.0.

TLX101-Tx targets L-type amino acid transporter 1, which is typically overexpressed in glioblastoma. Telix said the small-molecule approach is intended to cross the blood-brain barrier and deliver radiation therapy to the tumor.

Earlier data from the IPAX-1 study reported median overall survival of 13 months from treatment initiation. Preliminary IPAX-Linz data showed median overall survival of 12.4 months from treatment initiation, according to Telix.

Regulatory approvals for IPAX BrIGHT have been received in Australia, Austria, Belgium, and the Netherlands. Telix said additional approvals are being sought.

TLX101-Tx has orphan drug designation in the U.S. and Europe for glioma treatment. Telix said neither TLX101-Tx nor TLX101-Px has received marketing authorization in any jurisdiction.