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RECRUITING
NCT05533242
PHASE1

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

Sponsor: University Hospital Muenster

View on ClinicalTrials.gov

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

Official title: A Phase I Trial to Determine the Maximum Tolerated Dose and Patient-specific Dosimetry of Fractionated Intracavitary Radioimmunotherapy with Lu-177 Labeled 6A10 Fab-fragments in Patients with Glioblastoma After Standard Treatment

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2024-01-22

Completion Date

2026-04

Last Updated

2025-03-30

Healthy Volunteers

No

Interventions

DRUG

Lu-177 labeled 6A10-Fab-fragments

The antibody 6A10 is a specific CA12 Inhibitor, a highly specific glioma cell-associated enzyme; all tumor cells are CA12-positive, while its expression in normal brain is very low, and Lu-177 has a comparable β-emission, but a significantly low γ-Emission.

Locations (7)

Klinik für Allgemeine Neurochirurgie des Universitätsklinikums Köln

Cologne, Germany

Klinik für Nuklearmedizin des Universitätsklinikums Köln

Cologne, Germany

Klinik für Neurochirurgie des Universitätsklinikums Essen

Essen, Germany

Klinik für Nuklearmedizin, Strahlenklinik des Universitätsklinikums Essen

Essen, Germany

Klinik für Nuklearmedizin der Universität Münster

Münster, Germany

Universitätsklinikum Würzburg - Neurochirurgie

Würzburg, Germany

Universitätsklinikum Würzburg - Nuklearmedizin

Würzburg, Germany