eligibility_summary
Adults 18–70, ECOG 0–1, untreated, resectable EGFR+ HNSCC. Stages: III/IVA/IVB non-oropharyngeal or HPV− oropharyngeal, II–III HPV+ oropharyngeal (p16). Adequate organ function, LVEF≥50%, contraception and negative pregnancy test. Exclude certain primaries/histologies, neuropathy≥2, recent IV antibiotics/trials/vaccines/immunostims/major surgery/prior IO, recent CV events, active HBV/HCV/HIV/infections, >10% weight loss/bleeding, active autoimmune/immunosuppression, severe lung disease, transplant, severe allergy, or other serious conditions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Randomized phase II neoadjuvant trial in EGFR-positive, resectable HNSCC testing: 1) MRG003 (antibody–drug conjugate, anti-EGFR) + pucotenlimab (anti–PD-1 monoclonal antibody, immune checkpoint inhibitor) vs 2) the same combo plus cisplatin (platinum cytotoxic chemotherapy). Three induction cycles before surgery, adjuvant pucotenlimab afterward. Mechanisms: MRG003 binds EGFR on tumor cells and delivers a microtubule-disrupting payload (MMAE), causing mitotic arrest/apoptosis and potentially EGFR signaling blockade. Pucotenlimab blocks PD-1 to reinvigorate tumor-specific T-cell activity. Cisplatin creates DNA crosslinks, triggering apoptosis and may enhance immunogenic cell death. Targets/pathways: EGFR-expressing tumor cells, microtubules, DNA damage response, and the PD-1/PD-L1 immune checkpoint on T cells. Primary endpoint: pathologic response rate.