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

NCT05533242 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-13

No results posted yet for this study

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

Conditions

  • Glioblastom WHO Grade 4

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.

Sponsors & Collaborators

  • Isotope Technologies Munich (ITM) Oncologics

    collaborator UNKNOWN

  • Helmholtz Zentrum München Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH)

    collaborator UNKNOWN

  • University Hospital Muenster

    lead OTHER

Principal Investigators

  • Walter Stummer, Prof. · University Hospital Muenster, Klinik und Poliklinik für Neurochirurgie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-22
Primary Completion
2026-10-31
Completion
2027-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05533242 on ClinicalTrials.gov