Overview

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

Status:
Not yet recruiting

Trial end date:
2023-12-01

Target enrollment:

Participant gender:

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

Phase:

Phase 1

Details

Lead Sponsor:

University Hospital Muenster

Collaborators:

Helmholtz Zentrum München Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH)
Isotope Technologies Munich (ITM) Oncologics

Treatments:

Immunoglobulin Fab Fragments