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eligibility_summary
Inclusion: adults ≥18 with advanced/metastatic GI (incl CRC, pancreatic, liver), head/neck, or lung cancer, progressed on/unsuitable for standard therapy, ECOG 0–1, measurable extracranial disease, consent to tumor sampling, B7‑H6 positivity required except CRC. Exclusion: major surgery <28d, recent other cancers, leptomeningeal/spinal cord compression, uninterruptible anticoagulation, active HBV/HCV, recent infection, uncontrolled HIV. Further criteria apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drugs/interventions and mechanisms: BI 765049 is a B7‑H6–targeted, CD3‑redirecting bispecific T‑cell–engaging monoclonal antibody that binds B7‑H6 on tumor cells and CD3 on T cells to activate and redirect cytotoxic T‑cell killing, ezabenlimab (BI 754091) is an anti‑PD‑1 IgG4 monoclonal antibody checkpoint inhibitor that blocks PD‑1/PD‑L1 signaling to restore T‑cell function. Cells/pathways targeted: B7‑H6–positive solid tumor cells, CD3/T‑cell receptor signaling on cytotoxic T lymphocytes, PD‑1 immune checkpoint pathway. The combination is intended to enhance tumor‑specific T‑cell killing and overcome adaptive immune resistance.