eligibility_summary
Key eligibility: Adults (≥18) with histologically confirmed primary progressive diffuse glioma that failed standard care, archived tumor available and centrally confirmed DLL3-positive, measurable progression per RANO after RT/chemo, KPS ≥70, consent. Exclude: prior participation/other trials, extracranial/leptomeningeal disease, prior DLL3 therapy, anti-VEGF ≤6 mo, recent therapy (≤21 d/5 half-lives), RT <3 mo unless progression outside field. Further criteria apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05916313: Phase Ib, open-label, dose-escalation study in adults with progressive DLL3-positive diffuse glioma. Intervention: BI 764532 (obrixtamig), an antibody-like bispecific T‑cell engager (bispecific antibody) given by IV monotherapy. Mechanism of action: simultaneously binds DLL3 on tumor cells and CD3 on T cells, redirecting and activating T lymphocytes to form an immune synapse, release cytotoxic mediators, and kill DLL3+ cells. Targets: DLL3 (a Notch pathway ligand aberrantly expressed on glioma cells) and CD3 on T cells, pathways involved include Notch/DLL3 on tumor cells and T‑cell activation via CD3 signaling. Primary goal: determine the maximum tolerated dose and safety.