eligibility_summary
Adults 18–75 with advanced/metastatic solid tumors (stage 1) or NSCLC (stage 2) refractory/intolerant/no standard therapy, ≥1 RECIST 1.1 lesion, ECOG 0–1, life expectancy >3 mo, adequate organs, HCC Child‑Pugh A. Exclude: other cancers ≤2 yrs, NSCLC large cell/adenosquamous/rare or neuroendocrine, ILD, allergy to protein/monoclonal, serious eye disorders, IV-treated infection ≤2 wks, uncontrolled CV/CNS mets, steroids/immunosuppressants (stop ≥2 wks), strong CYP2D6/3A ≤2 wks, immunodeficiency/HIV, active HBV/HCV, pregnancy, other risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: HLX42, an anti-EGFR antibody–drug conjugate (ADC, targeted cytotoxic therapy) with a drug–antibody ratio of 8, coupling an EGFR-specific monoclonal antibody to a novel, high‑potency DNA topoisomerase I inhibitor. Mechanism: The antibody binds EGFR on tumor cells, is internalized, and releases the topo I inhibitor to cause DNA damage/replication stress and apoptosis, the mAb component may also block EGFR signaling. Targets: EGFR-expressing tumor cells in advanced/metastatic solid tumors, with a focus on NSCLC. Pathways affected: EGFR signaling cascades (RAS/MAPK, PI3K/AKT) at the membrane and nuclear DNA replication/repair via topo I inhibition. Dose arms in stage 2: HLX42 2.0 vs 2.5 mg/kg Q3W.