Key Takeaways
- IPAX-2 study of TLX101-Tx in first-line glioblastoma fully enrolled 12 patients.
- No dose-limiting toxicities were seen up to the maximum 10GBq dose.
- Pivotal Phase 3 IPAX BrIGHT trial in recurrent glioblastoma is actively enrolling.
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Telix completes glioblastoma trial enrollment with 0 dose-limiting toxicities
Telix Pharmaceuticals has completed patient enrollment for its Phase 1 IPAX-2 study of TLX101-Tx in newly diagnosed glioblastoma, reporting zero dose-limiting toxicities observed in 12 patients.
"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," Dr. David N. Cade, Group Chief Medical Officer at Telix, said.
The study enrolled 12 patients across three dose-escalating cohorts in Australia, Austria, and the Netherlands. The maximum administered dose reached was 10GBq, delivered in two 5GBq doses, with the primary endpoint of determining the maximum tolerated dose to be confirmed at study completion.
The positive safety data is a key de-risking event for TLX101-Tx, a radiopharmaceutical therapy targeting the LAT1 protein over-expressed in glioblastoma. The company is also advancing the candidate in a pivotal Phase 3 trial, IPAX BrIGHT, for recurrent glioblastoma.
TLX101-Tx (¹³¹I-iodofalan) is a small molecule designed to cross the blood-brain barrier to treat the most aggressive form of primary brain cancer. Glioblastoma has a median survival of just 12-15 months from diagnosis, and recurrence occurs in nearly all patients.
Previous studies have shown promising survival data. The IPAX-1 study in recurrent glioblastoma reported a median overall survival of 13 months from the start of TLX101-Tx treatment. The pivotal IPAX BrIGHT trial is the first radiopharmaceutical therapy to enter Phase 3 development for this cancer.
The completion of enrollment and positive safety profile from IPAX-2 provide crucial support for the ongoing, larger-scale Phase 3 trial. Investors will now look toward the determination of the maximum tolerated dose and any initial efficacy signals from the study as the next catalysts for the TLX101-Tx program.
This article is for informational purposes only and does not constitute investment advice.
[1] IPAX-2 Study of TLX101-Tx in First-line Glioblastoma Completes Enrolment and Confirms Dosing[2] IPAX-2 Study of TLX101-Tx in First-line Glioblastoma Completes Enrolment and Confirms Dosing - Thailand Business News[3] Telix completes enrollment in glioblastoma therapy trial By Investing.com - Investing.com Canada[4] IPAX-2 Study of TLX101-Tx in First-line Glioblastoma Completes Enrolment and Confirms Dosing - The Manila Times
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