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Clinical Trials in Germany / NCT05533242
Active, not recruiting Phase 1

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

NCT05533242 · tracked via the Priya Life Science Germany tracker
Phase
Phase 1
Started
2024-01-22
Last updated
2026-09-21

Condition(s) studied

Glioblastom WHO Grade 4

Investigational drug(s) / intervention(s)

Lu-177 labeled 6A10-Fab-fragments

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.

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Written patient consent after comprehensive information * Age between 18 and 80 years * Primary supratentorial high grade glioma after standard therapy (fluorescence-guided surgery, radio-chemotherapy, concomitant + adjuvant chemotherapy), with no or stable small tumor residue (residual contrast enhancement of up to 5cm3) at earliest 6 weeks after completion of radiotherapy * Histological verification of glioblastoma and CA 12-expression of tumor cells confirmed * Karnofsky-score ≥ 60 * Volume of resection cavity 2,5-25 cm3 * Male and female patients with reproductive potential must use an approved contraceptive method * Pre-menopausal female patients with childbearing potential: a negative serum pregnancy test must be obtained prior to treatment start * Adequate bone marrow reserve: white blood cell (WBC) count ≥3000/μl, granulocyte count \>1500/μl, platelets ≥100000/μl, hemoglobin ≥ 10 g/dl * Adequate liver function: bilirubin \< 1.5 times above upper limit of normal range (ULN), alanine transaminase (ALT/SGPT) and aspartate transaminase (AST/SGOT) \< 3 times ULN. In the case of documented or suspected Gilbert's disease bilirubin \< 3 times ULN. * Blood clotting: INR (=PT) and PTT within acceptable limits according to the investigator * Adequate renal function: creatinine \< 3 times above ULN; eGFR \> (or equal) 60 ml/min Exclusion Criteria: * Patient unable to undergo imaging by CT, PET or contrast-enhanced MRI for whatever reason (i.e., pacemaker) * Resection cavity with intraventricular access * Significant leakage of radioactivity into CSF spaces or ventricles * Other actively treated invasive malignancy * Breastfeeding women * Past medical history of diseases with poor prognosis, e.g., severe coronary heart disease, heart failure (NYHA III/IV), severe and poorly controlled diabetes, immune deficiency, residual deficits after stroke, severe mental retardation, pre-existing neurological diseases except those related to glioblastoma or other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) * Any active infection (at the discretion of the investigator) * Previous participation in a registered clinical trial with therapeutic intervention less than 6 weeks prior to enrolment (date of informed consent) * Allergy against known constituents of study medication

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
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

More University Hospital Muenster trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05533242 on ClinicalTrials.gov ↗ ← All trials in Germany