eligibility_summary
Include: adults 18–75 with recurrent/metastatic HNSCC (hist/cyto‑confirmed), ineligible for local therapy, progressed after PD‑1/L1 and/or platinum (≤2 lines), ECOG 0–1, CDKN2A loss, measurable disease, adequate organs, >3‑mo survival. Exclude: recent therapy/surgery/radiation, active/unstable CNS mets, major cardiac/QTc or VTE, uncontrolled disease/infections, active HBV/HCV/HIV, autoimmune or transplant, serious pulmonary disease/effusions, pregnancy/breastfeeding, other serious illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06509997 (Phase II, single-arm) in recurrent/metastatic HNSCC with CDKN2A loss after PD‑1/platinum. Interventions: MRG003 + dalpiciclib. Drug types and mechanisms: • MRG003: anti-EGFR antibody-drug conjugate (ADC). Binds EGFR on tumor cells, internalizes, and releases a microtubule-disrupting payload (MMAE), causing mitotic arrest and apoptosis, IgG1 backbone may also mediate ADCC. • Dalpiciclib (dalpicicilip): oral small‑molecule CDK4/6 inhibitor that blocks CDK4/6‑mediated RB phosphorylation, arresting the cell cycle at G1‑S. Targets/cells/pathways: • EGFR-expressing HNSCC cells and downstream EGFR signaling (MAPK/PI3K). • Cell-cycle machinery in tumors with CDKN2A (p16INK4a) loss, where CDK4/6 activity is unchecked, inhibition restores RB control. Primary endpoints: objective response rate and safety.