eligibility_summary
Eligible: healthy males 18–50, BMI 18.5–28, weight ≥50 kg, normal vitals/labs/ECG/CXR/abdominal US, uses effective contraception (non-drug during trial), no sperm donation during and 3 months post-dose, informed consent. Exclude: allergies/infusion reactions, significant systemic disease, bleeding/coagulation or thrombosis, keratitis/severe dry eye, recent surgery, needle phobia, drug abuse (6 mo) or narcotics (3 mo), recent blood/blood products (3 mo), prior anti-EGFR/other mAbs (3 mo), or unsuitable by investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1 randomized, single-dose, parallel study in healthy adult Chinese males compares HLX05 with Erbitux (US/EU/CN-sourced cetuximab). Interventions: a single IV dose (250 mg/m2) of a recombinant anti-EGFR human/murine chimeric IgG1 monoclonal antibody. Mechanism of action: binds the extracellular domain of EGFR (ErbB1/HER1), blocks ligand (EGF/TGF-α) binding and receptor activation, promotes receptor internalization, and inhibits downstream signaling (RAS-RAF-MEK-ERK and PI3K-AKT), reducing proliferation/survival of EGFR-overexpressing cells. The IgG1 Fc can engage immune effector cells to mediate ADCC. Targets: EGFR on epithelial/tumor cells, EGFR signaling pathway and its downstream cascades, Fcγ receptor–bearing immune cells (e.g., NK cells, macrophages). Primary aim: compare pharmacokinetics, safety, and immunogenicity of HLX05 vs cetuximab.