Helmholtz Munich together with University Hospital Münster (UKM) and ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, have announced updated preliminary results from their joint Phase I clinical trial of investigational candidate ITM-31 in patients with glioblastoma.
The investigator-initiated Phase I trial (NCT05533242) is a prospective, single-arm, multicenter, dose-escalation study evaluating the safety, tolerability and maximum tolerated dose of ITM-31, as well as progression-free survival (PFS) and overall survival (OS) in patients with newly diagnosed glioblastoma, following surgical resection and standard radio-chemotherapy, with no or minimal residual disease. ITM-31 is designed as a maintenance therapy applied during a period of stability. Enrolment started in January 2024 and is now complete, and the initial six-month follow-up period for all patients is expected to be completed by the end of 2026. The ten enrolled patients across four clinical sites at German university hospitals will continue to be followed for up to two years after initial treatment with ITM-31.
Preliminary data were recently presented at the Nuclear Medicine and Neuro-Oncology (NMN) Society Annual Symposium, in Vienna, Austria.
ITM-31 (177Lu-6A10-Fab) is administered via intracavitary injection directly into the post-surgical resection cavity, enabling targeted radiation of residual tumour cells, bypassing the blood-brain barrier. The goal is to eradicate residual tumour cells following surgery to reduce the risk of relapse.
Glioblastoma is the most common and aggressive primary malignant brain tumour in adults, accounting for nearly half of all gliomas and affecting more than 25,000 patients annually in Europe and over 100,000 worldwide. Despite standard treatment with surgery, radiation and chemotherapy, outcomes remain poor, with median overall survival of approximately 15–20 months. Recurrence mostly occurs around the original tumour site, underscoring the need for effective locoregional therapies.
Under a licensing agreement with Helmholtz Munich, ITM holds exclusive rights to develop and commercialize ITM-31. As Helmholtz Munich’s long-standing technology transfer partner, Ascenion worked closely with the institute’s Innovation & Entrepreneurship Department to structure the corresponding licence agreement with ITM and support subsequent follow-up activities.
Further information: Press release of Helmholtz Munich
