Clinical trial • Phase I • Oncology

Lutetium-177 labelled 6A10 antibody Fab fragment for Glioblastoma|High-grade glioma

Phase I trial of Lutetium-177 labelled 6A10 antibody Fab fragment for Glioblastoma|High-grade glioma. 15 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Glioblastoma|High-grade glioma
Trial Stage
Phase I
Drug Modality
Radiopharmaceutical|Other antibody

Key dates

Initial CTIS Submission Date
19-06-2024
First CTIS Authorization Date
10-07-2024

Trial design

Phase I trial across 8 sites in Germany.

Target Sample Size
15

Eligibility

Recruits 15 No vulnerable population selected.

Vulnerable Population
No vulnerable population selected

Recruitment

Planned Sample Size
15
Recruitment Window Months
25

Geography

Total Number Of Sites
8
Total Number Of Participants
15

Germany

Earliest CTIS Part Ii Submission Date
01-07-2024
Latest Decision Or Authorization Date
06-01-2026
Processing Time Days
554
Number Of Sites
8
Number Of Participants
15

Sites

Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Neurochirurgischen Klinik und Poliklinik
Contact Person Name
Mario Löhr
Contact Person Email
Loehr_M1@ukw.de
Site Name
University Hospital Cologne AöR
Department Name
Klinik für Nuklearmedizin
Contact Person Name
Alexander Drzezga
Contact Person Email
alexander.drzezga@uk-koeln.de
Site Name
University Hospital Cologne AöR
Department Name
Zentrum für Neurochirurgie
Contact Person Name
Roland Goldbrunner
Contact Person Email
roland.goldbrunner@uk-koeln.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Neurochirurgie
Contact Person Name
Yahya Ahmadipour
Contact Person Email
Yahya.Ahmadipour@uk-essen.de
Site Name
Universitaet Muenster
Department Name
Klinik für Nuklearmedizin
Contact Person Name
Michael Schäfers
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Nuklearmedizin, Strahlenklinik
Contact Person Name
Ken Herrmann
Contact Person Email
ken.herrmann@uk-essen.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Nuklearmedizinische Klinik und Poliklinik
Contact Person Name
Kerstin Michalski
Contact Person Email
michalski_k@ukw.de
Site Name
Universitaet Muenster
Department Name
Klinik für Neurochirurgie
Contact Person Name
Walter Stummer
Contact Person Email
walter.stummer@ukmuenster.de

Sponsor

Primary sponsor

Full Name
Universitaetsklinikum Muenster AöR
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Germany

Investigational products

Investigational Product Name
Lutetium-177 labelled 6A10 antibody Fab fragments
Active Substance
Lutetium-177 labelled 6A10 antibody Fab fragment
Modality
Radiopharmaceutical|Other antibody
Routes Of Administration
Intracavitary (applied to the tumor resection cavity)
Route
Intracavitary

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