Drug intelligence / Profile preview

AMG 596 + AMG 404

Development stage
Unknown
Lead developer
Amgen
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

AMG 596 + AMG 404 is an investigational combination drug regimen being studied for the treatment of glioblastoma or malignant glioma expressing mutant epidermal growth factor receptor variant III (EGFRvIII). - **AMG 596** is a bispecific monoclonal antibody designed to activate T cells against tumor cells by binding both CD3 on T cells and EGFRvIII on tumor cells. - **AMG 404** is a fully human monoclonal antibody that targets programmed cell death protein 1 (PD-1), functioning as a checkpoint inhibitor to enhance anti-tumor immune response. The combination is tested in a first-in-human, open-label, sequential dose-escalation phase 1/1b trial. AMG 596 is given by continuous intravenous infusion; AMG 404 is administered by short intravenous infusion. The main goals are to assess safety, tolerability, pharmacokinetics, and exploratory efficacy, particularly in EGFRvIII-positive glioblastoma and malignant glioma patients who have recurrent disease or are in the maintenance setting after standard of care[1][3][4].

02

Targets

CD3 (T-cell surface glycoprotein CD3)EGFRvIII (Epidermal growth factor receptor variant III)PDCD1 (Programmed cell death protein 1 receptor)

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