Clinical Trial

Radioimmunotherapy With Lu-177 Labeled 6A10 Fab-fragments in Patients With Glioblastoma After Standard Treatment

Study acronym: RIT in GBM

Active, Not Recruiting Phase 1

Summary

Locoregional, intracavitary radioimmunotherapy (iRIT) with a newly developed radioimmunoconjugate (Lu-177 labeled 6A10-Fab-fragments) will be used to prevent or postpone tumour recurrence in patients with GBM following standard therapy . Following study objectives will be analyzed: * Determining the Maximum Tolerated Dose (MTD) * Determining safety by assessing all new neurological, hematological and other AEs CTC grade 2 or higher * Determining absorbed dose to the 2 cm shell of the resection cavity (based on a series of SPECT/CTs of the head 2h,24h,48h, 72h p.i. and on day 5-7) * Determining absorbed dose values for the kidneys, the liver, the active marrow (based on a series of SPECT/CTs of the abdomen 2h,24h,48h, 72h p.i. and on day 5-7) * Determining 24 weeks Progression-Free-Survival (PFS), defined from the day of inclusion

Protocol Amendment History 6 amendments

This ClinicalTrials.gov record has been amended 6 times since 2022-09-05; most recent amendment 2026-05-08.

Status change: Recruiting → Active, Not Recruiting 2026-05-08

Status change: Not Yet Recruiting → Recruiting 2022-10-18

Trial Details

NCT Number	NCT05533242
Lead Sponsor	University Hospital Muenster Collaborators: Isotope Technologies Munich (ITM) Oncologics, Helmholtz Zentrum München Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH)
Conditions	Glioblastom WHO Grade 4
Enrollment	15 participants
Start Date	2024-01-22
Primary Completion	2026-10 (estimated)
Study Completion	2027-10 (estimated)
Updated on ClinicalTrials.gov	2026-05-13