Telix has dosed the first subject in a Phase II clinical trial of TLX101 (4-L-[131I] iodo-phenylalanine, or 131I-IPA) plus external beam radiation therapy (EBRT) in recurrent high-grade glioma (HGG) patients, including those with glioblastoma multiforme (GBM).
Named IPAX-Linz, the investigator-initiated trial is being carried out at Kepler University Hospital in Linz, Austria.
It will assess TLX101’s benefit in subjects in the second line (refractory) setting at this European neuro-oncology site.
The trial plans to recruit ten subjects to obtain further data on the clinical utility of the therapy.
IPAX-Linz will be carried out alongside IPAX-2, which is assessing TLX101 plus a post-surgical standard of care containing EBRT and temozolomide in patients with recently diagnosed (first-line) GBM.
This Phase II trial builds on data from the IPAX-1 study reported in September this year.
According to IPAX-1 findings, TLX101 showed an encouraging safety profile and initial treatment effects.
A lead therapeutic clinical programme of the company, TLX101 acts on the L-type amino acid transporter 1 (LAT-1).
LAT-1 is usually over-expressed in various malignant tumours, including HGG/GBM.
TLX101 has received orphan drug designation in the US and Europe.
Telix Pharmaceuticals chief medical officer Dr Colin Hayward said: “We are pleased to have commenced the IPAX-Linz study which, alongside IPAX-2, supports Telix’s goal to expedite the development of a potential new therapy in an aggressive cancer with poor prognosis.”
In May last year, the company commenced the Phase III ProstACT clinical trial of TLX591 (177Lu-DOTA-rosopatamab) in patients with advanced metastatic castrate-resistant prostate cancer.
The trial was initiated after Telix received approval from the Human Research Ethics Committee (HREC) and clearance of Clinical Trial Notification (CTN) from the Australian Therapeutic Goods Administration (TGA).