eligibility_summary
Adults 18–75 with extensive-stage SCLC, ECOG 0–1, ≥3‑mo survival, RECIST‑measurable disease, adequate organ function. Cohorts: A ≥3 prior lines failed/intolerant, B‑I failed/intolerant to standard, B‑II systemic‑naïve. Exclude: prior EGFR/HER3 mAbs, recent therapy, (B) severe irAEs/myocarditis or recent immunomodulators, serious CV/cerebrovascular disease, autoimmune/ILD, uncontrolled DM/HTN, recent thrombosis, active CNS mets unless treated/stable <10 mm, effusions, antibody allergy, active HIV/TB/HBV/HCV, other high‑risk conditions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase II in extensive-stage SCLC testing BL-B01D1, SI-B003, and their combination. Drugs/mechanisms: • BL-B01D1 (izalontamab brengitecan, BMS-986507): a bispecific antibody–drug conjugate (ADC) targeting EGFR and HER3. Upon binding and internalization into tumor cells, it releases a camptothecin/topoisomerase I–inhibitor (“-tecan”) payload, causing DNA damage and cytotoxicity. • SI-B003: an immune checkpoint inhibitor monoclonal antibody blocking the PD-1/PD-L1 pathway to reinvigorate T-cell antitumor activity (IV infusion). Cells/pathways targeted: • Tumor cells expressing EGFR/HER3 (ERBB signaling) and nuclear topoisomerase I. • Activated T cells (PD-1) and tumor/immune cells expressing PD-L1, modulating the tumor immune microenvironment. Combination aims to couple ADC-driven tumor cell kill with PD-1 pathway–mediated immune activation.