Trial of Telix glioblastoma treatment completes patient enrollment
Study finds no dose-limiting toxicities as maximum dose reached
Written by |
A Phase 1 clinical trial testing TLX101-Tx, Telix Pharmaceuticals‘ experimental treatment for glioblastoma (an aggressive form of glioma), has completed enrollment.
The study, IPAX-2 (NCT05450744), enrolled 12 people with newly diagnosed glioblastoma. All patients received TLX101-Tx at one of three doses, with the main goal of evaluating the therapy’s safety profile and identifying the optimal dose for future clinical testing.
Telix said that so far, no dose-limiting toxicities have been reported in the study, including in two patients who received the highest tested dose. A dose-limiting toxicity is a serious side effect that indicates the tested dose of an experimental treatment is too high to be safely used as medicine.
“We are pleased to have completed enrolment in IPAX-2, an important milestone in the development of TLX101-Tx as a potential treatment for first-line glioblastoma,” David N. Cade, group chief medical officer at Telix, said in a company press release. “The tolerability amongst patients, and the absence of dose-limiting toxicities observed on this study strongly support the continued development of this targeted radiopharmaceutical candidate.”
Radioactive material aims to kill cells
TLX101-Tx, also known as iodofalan 131I, consists of a piece of radioactive material attached to a small molecule that binds to a protein expressed by glioma cells, LAT1. The therapy aims to deliver the toxic radioactive material directly to LAT1-expressing glioma cells, killing them.
In addition to the IPAX-2 study in newly diagnosed glioblastoma, Telix is sponsoring a Phase 3 clinical trial called IPAX BrIGHT (NCT07100730) that is testing the therapy in people with recurrent glioblastoma (meaning the tumor has regrown following standard treatments like surgery, chemotherapy, and/or radiation).
Participants in IPAX BrIGHT are being randomly assigned to treatment with TLX101-Tx in addition to the standard chemotherapy Gleostine (lomustine), or to Gleostine alone. The main goal is to test the safety profile and identify the optimal dose for add-on TLX101-Tx. Recruitment is ongoing at sites in Australia, Austria, and the Netherlands. The trial will also soon start enrollment in Belgium, per Telix.
In parallel with TLX101-Tx, Telix is developing TLX101-Px, an experimental imaging agent that aims to help clinicians visualize the LAT1 protein on glioma tumors. The imaging agent is currently under regulatory review in the U.S. and in Europe.
Leave a comment
Fill in the required fields to post. Your email address will not be published.