eligibility_summary
Adults 18–75 with newly diagnosed ES‑SCLC, ECOG 0–1, ≥3‑mo survival, measurable disease, tumor tissue available, adequate organ function, prior AEs ≤G1, women: negative pregnancy test/contraception. Exclude: prior topo‑I ADC or systemic therapy, mixed histology, immunosuppression, CV/QT/arrhythmias, autoimmune/ILD, uncontrolled DM/HTN, thrombosis, serious pulm disease or CNS mets, large effusions, active viral infections or severe infection, transplant, allergy, live vaccine.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06437509 (Phase II) in extensive-stage small cell lung cancer. Interventions and mechanisms: • BL-B01D1 (aka iza-bren, izalontamab brengitecan, BMS-986507) – an antibody–drug conjugate (ADC). The antibody binds a tumor-associated surface antigen and is internalized, releasing a “-gitecan” topoisomerase I inhibitor payload that induces DNA damage and tumor cell death. • PD-1 monoclonal antibody (checkpoint inhibitor, e.g., spartalizumab class) – blocks PD-1 on T cells to restore anti-tumor immunity. Target cells/pathways: • Tumor cells expressing the BL-B01D1 target antigen (antigen not specified in the record), leading to topo I–mediated DNA damage. • PD-1/PD-L1 checkpoint on T lymphocytes, enhancing cytotoxic T-cell activity within the tumor microenvironment. The combination aims to pair direct ADC cytotoxicity with immune activation.