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eligibility_summary
Adults (≥18) with DLL3+ SCLC, LCNEC, or other NEC/small-cell cancers (predominant ≥50%), after platinum-based therapy and no proven options, ECOG 0–1, ≥1 non‑CNS measurable lesion. Stable/treated brain mets allowed. Contraception required. Exclude: prior DLL3 TcE/cell therapy, recent/active other cancers, recent major surgery/injury, leptomeningeal/cord compression, uninterruptible anticoagulation, recent infection/COVID, active HBV/HCV. Further criteria apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I, open-label dose-escalation of obrixtamig (BI 764532) plus ezabenlimab in adults with DLL3-positive small cell lung cancer and other neuroendocrine carcinomas after standard therapy. Drugs/mechanisms: Obrixtamig is a bispecific T‑cell engager antibody (DLL3×CD3) given IV that binds DLL3 on tumor cells and CD3 on T cells to redirect/activate cytotoxic T cells and induce tumor lysis. Ezabenlimab is an anti–PD‑1 monoclonal antibody (checkpoint inhibitor) that blocks PD‑1 to relieve T‑cell exhaustion and sustain activity. Targets/pathways: DLL3 on neuroendocrine tumor cells (Notch/DLL3 axis), CD3 on T cells, and the PD‑1/PD‑L1 immune checkpoint pathway. Primary aim: determine obrixtamig MTD and safety in combination.