eligibility_summary
Adults 18–75 with recurrent/metastatic SCCHN after PD‑1/L1 and platinum (≤2 lines), measurable disease, ECOG 0–1, life ≥3 mo, adequate organ function, negative pregnancy test and contraception. Exclude: ≥G2 neuropathy, need for other cancer therapy/surgery or recent chemo/RT/IO, unstable CNS mets, unresolved >G1 tox, cardiac/VTE, uncontrolled disease/bleeding, EGFR/mAb/MRG003 allergy, active HBV/HCV/HIV or serious infection, immunosuppression or steroids >10 mg.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05751512 tests MRG003 vs cetuximab or methotrexate in recurrent/metastatic SCCHN after PD‑1/L1 and platinum failure. MRG003: an EGFR‑targeted antibody–drug conjugate (ADC) that binds EGFR on tumor cells, is internalized, and releases the microtubule toxin MMAE (vedotin class), disrupting microtubules (G2/M arrest → apoptosis). Cetuximab: chimeric anti‑EGFR monoclonal antibody that blocks ligand binding/EGFR activation and mediates ADCC. Methotrexate: antimetabolite chemotherapy inhibiting DHFR, depleting thymidylate/purines and DNA synthesis. Targeted cells/pathways: EGFR‑expressing head/neck SCC cells, EGFR signaling (RAS/RAF/MEK/ERK, PI3K/AKT), microtubule cytoskeleton (MMAE), folate/DNA synthesis pathway (DHFR). Phase III, randomized, open‑label, China.