eligibility_summary
Inclusion: ≥18, locally advanced/metastatic NSCLC or NPC, OS ≥3 mo, measurable lesion, ECOG 0–1, 6–10 tumor slides/fresh tissue, prior AEs ≤G1, adequate organ/coag, LVEF ≥50%, urine protein ≤2+ or ≤1 g/day, neg pregnancy/contraception. Exclusion: recent systemic therapy, EGFR/ALK-defined cohorts, major cardiac/QT/arrhythmia, ILD/severe lung dz, active CNS dz, uncontrolled effusions, active HIV/TB/HBV/HCV, bleeding/thrombosis, autoimmune dz, other cancer ≤5 y, recent trial.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm study testing BL-B01D1 (izalontamab brengitecan, BMS-986507) plus a PD-1 monoclonal antibody in advanced/metastatic NSCLC, nasopharyngeal carcinoma, and other solid tumors. Drugs/mechanisms: • BL-B01D1: an antibody–drug conjugate (ADC). After binding a tumor-associated surface antigen, it is internalized and releases a camptothecin-class/topoisomerase I inhibitor payload (“-gitecan”), causing DNA damage and tumor cell death. • PD-1 monoclonal antibody: an immune checkpoint inhibitor that blocks PD-1 on T cells, reversing exhaustion and enhancing antitumor immunity. Target cells/pathways: • Tumor cells expressing the ADC’s target antigen → topo I–mediated DNA damage/apoptosis. • PD-1/PD-L1 axis on T lymphocytes → restoration of T-cell–mediated cytotoxicity. The combination aims to pair direct tumor killing with immune activation.