NCT07100730

Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma

A Global, Multicenter, Prospective, Controlled, Open-Label Pivotal Study of Iodofalan (131I) Solution for Injection (TLX101-Tx) Plus Lomustine Versus Lomustine Alone in Patients With Radiographically Confirmed Recurrent Glioblastoma at First Recurrence (IPAX BrIGHT [IPAX-3])

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This global clinical trial which evaluates the efficacy and safety of TLX101-Tx, an investigational radiopharmaceutical therapy, in combination with lomustine versus lomustine alone in adult patients with first recurrence of glioblastoma. TLX101-Tx delivers targeted radiation to glioblastoma cells. The trial is conducted in two parts: Part 1 assesses safety and radiation dosing; Part 2 is a randomized comparison of the combination therapy against standard care.

Conditions

• Neoplastic Disease
• Glioblastoma
• Glioblastoma (GBM)
• Glioblastoma Multiform
• Glioblastoma Multiforme, Adult
• Glioblastoma Multiforme (GBM) WHO Grade IV

Interventions

Type	Name	Description
COMBINATION_PRODUCT	TLX-101-Tx + Lomustine	Combination therapy with TLX-101-Tx + Lomustine
RADIATION	TLX101-Tx	TLX101-Tx

Timeline

• Start date: 2025-11-02
• Primary completion: 2027-07-01
• Completion: 2027-11-01
• First posted: 2025-08-03
• Last updated: 2026-04-16

Locations

4 sites across 3 countries: Australia, Austria, Netherlands