eligibility_summary
Phase 1b GBM: ≥16 with WHO grade 4 GBM/IDH‑mut astrocytoma or H3 G34 glioma. Phase 1 needs WGS/RNA data. Eligible at first relapse (measurable) or post‑Stupp MRD, PS 0–1, life expectancy ≥12 wks, adequate labs, contraception required. Exclude: recent therapy (washouts), prior ICI/EGFR/vaccine therapy, ≥G2 toxicity, leptomeningeal disease/hemorrhage, major CV/VTE/QTc issues, GI malabsorption, lung disease, active HBV/HCV/HIV, uncontrolled illness, dex >3 mg, recent live vaccine, surgery/RT, other trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drug/intervention: Amivantamab (JNJ-61186372), an IV bispecific IgG1 monoclonal antibody (targeted therapy/immunotherapy) against EGFR and MET. Mechanism of action: Binds EGFR and MET extracellular domains to block ligand-driven activation, inhibit downstream signaling, and promote receptor internalization/degradation, engages immune effector functions via its Fc domain to induce ADCC/ADCP. Targeted cells/pathways: EGFR‑amplified glioblastoma cells, EGFR and MET receptor tyrosine kinases, downstream PI3K/AKT/mTOR and RAS/RAF/MEK/ERK pathways, MET-mediated bypass resistance. Effector immune cells: NK cells and macrophages via Fcγ receptors. Trial: Phase 1b, single-arm, initially in relapsed GBM with EGFR amplification, evaluates safety/tolerability and preliminary activity at RP2D, dosing weekly ×4 then every 2 weeks.