eligibility_summary
Adults ≥18, ECOG 0–1, life ≥3 mo, adequate organs, fresh tumor biopsy. Arm B: LA/met sqNSCLC after SOC exhausted/refused, measurable disease. Arm C: advanced/met sqNSCLC, HNSCC, ESCC, CSCC or cervical SCC after ≥1 prior systemic therapy. Exclude: prior EGFR/HER3 Rx (HMBD‑001/cetuximab, docetaxel ok in Arm C), prior driver‑targeted Rx, unresolved ≥G2 AEs, inadequate washout, active CNS/cardiac, uncontrolled illness, HIV/active HBV/HCV, pregnancy/lactation, recent COVID‑19/vaccine, CYP3A4 drugs.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: HMBD-001 (humanized IgG1 anti-HER3 monoclonal antibody), cetuximab (chimeric IgG1 anti-EGFR monoclonal antibody), and docetaxel (taxane chemotherapy). Combinations tested: HMBD-001 + docetaxel, HMBD-001 + docetaxel + cetuximab, HMBD-001 + cetuximab. Mechanisms: HMBD-001 binds HER3 (ErbB3) to block HER3 activation and heterodimerization (e.g., with EGFR/HER2), suppressing downstream PI3K/AKT and MAPK signaling, its IgG1 Fc can engage ADCC. Cetuximab blocks EGFR ligand binding/activation and may induce ADCC. Docetaxel stabilizes microtubules, causing mitotic arrest and apoptosis. Targets: HER3+ and EGFR+ squamous tumor cells, the ErbB/EGFR–HER3 signaling axis and downstream PI3K/AKT–MAPK pathways, proliferating cancer cells, FcγR-expressing immune effector cells (e.g., NK cells) via ADCC.