Dose Finding Study of [177Lu]Lu-NeoB in Combination With RT and TMZ in Newly Diagnosed GBM.

This study will investigate different doses of [177Lu]Lu-NeoB in combination with RT and TMZ in participants with newly diagnosed GBM with methylated or unmethylated promoter to assess the safety and efficacy of [177Lu]Lu-NeoB in combination with the SoC to identify the recommended dose and to also explore the safety of the PET imaging agent [68Ga]Ga-NeoB and characterize its uptake in the tumor area.

Inclusion Criteria:Signed informed consent must be obtained prior to participation in the studyHistologically confirmed Glioblastoma according to WHO classification established following either a surgical resection or biopsyAdequate bone marrow and organ function as defined by the following laboratory values obtained within =< 14 days prior to receiving the first study treatmentPresence of gadolinium enhancement at the tumor region in the pre-surgery MRIKarnofsky performance status >= 60%Exclusion Criteria:Additional, concurrent, or active therapy for Glioblastoma outside of the present studyAdministration of a radiopharmaceutical with therapeutic intent within a period corresponding to 10 half-lives of the radionuclide used prior to injection of [68Ga]Ga-NeoBHistory or current diagnosis of impaired cardiac functionHistory of another active malignancy in the previous 3 years prior to study entryKnown hypersensitivity to any of the study treatments, their excipients or dacarbazine