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P07.21.A A PHASE I TRIAL TO DETERMINE THE MAXIMUM TOLERATED DOSE AND PATIENT-SPECIFIC DOSIMETRY OF FRACTIONATED INTRACAVITARY RADIOIMMUNOTHERAPY WITH LUTETIUM-177 LABELED 6A10 FAB FRAGMENTS IN PATIENTS WITH GLIOBLASTOMA - PRELIMINARY RESULTS FROM THE FIRST PATIENT COHORT.
Neuro. Oncol. 27, iii81 - iii82 (2025)
BACKGROUNDFollowing
maximal safe resection and standard adjuvant radio- and chemotherapy,
approved maintenance therapies for glioblastoma are lacking.
Intracavitary radioimmunotherapy (iRIT) injected into the resection
cavity offers a promising strategy for improving local tumor. MATERIAL AND METHODSThe
NOA-22 study (NCT05533242) investigates the 6A10-Fab fragment targeting
carboxyanhydrase XII, labelled with lutetium-177, in a prospective,
single-armed, multicenter phase I study setting, following a modified 3 +
3-design. Malignant glioma (WHO grades 3 + 4) IV and III) after
concomitant radio-chemotherapy and adjuvant standard chemotherapy with
no or small residual disease are included. The injected activity is
adapted to the volume of the resection cavity, resulting in a dose of
44Gy (cohort 1), 48Gy (cohort 2) and 52Gy (cohort 3). Primary study
objective is to determine the maximum tolerated dose and safety of
adjuvant radio-immunotherapy with lutetium-177 labeled 6A10-Fab
fragments. RESULTSThree
patients with glioblastoma concluded the first study cohort. No
toxicities beyond grade 2 (CTCAE Version 5) were noted. One patient
presented with a symptomatic increase in focal contrast enhancement and
perifocal edema that decreased after a course of steroid treatment,
consistent with therapy-associated changes. Dosimetry did not reveal
absorbed doses above upper dose limits for organs at risk. All patients
remain clinically stable and without tumor progression. CONCLUSIONIntracavitary
injection of Lutetium-177 labeled 6A10 Fab fragments appears to be
feasible and safe. The study currently enrolls patients in a planned
escalated dose scheme of 48 Gy cumulative dose in cohort 2.
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Publication type
Article: Journal article
Document type
Meeting abstract
Keywords
Lutetium
ISSN (print) / ISBN
1522-8517
e-ISSN
1523-5866
Journal
Neuro-Oncology
Quellenangaben
Volume: 27,
Issue: Supplement_3,
Pages: iii81 - iii82
Publisher
Oxford University Press
Reviewing status
Peer reviewed
Institute(s)
Institute of Structural Biology (STB)