eligibility_summary
Adults (≥18) with ECOG 0–1, life ≥12 wks, advanced unresectable/metastatic solid tumors (GI in expansion) with HER2 expression (IHC ≥1+ or HER2-mutant NSCLC), refractory/intolerant/no options, measurable disease, adequate organ function, LVEF ≥50%, washout, contraception, consent. Exclude: active CNS mets, recent other cancers, prior topo I ADC, uncontrolled illness, ILD/pneumonitis, recent COVID-19, uncontrolled effusions, unresolved ≥G2 tox, immunosuppression >10 mg pred, severe drug allergies, investigator risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: JSKN033, a fixed subcutaneous combination of JSKN003 and envafolimab, dosed weekly. Drug types and mechanisms: Envafolimab is an anti–PD-L1 monoclonal antibody checkpoint inhibitor that blocks PD-1/PD-L1 interaction to restore antitumor T‑cell activity. JSKN003 is a HER2-directed biologic, the record does not specify its exact modality, but it is intended to target HER2-expressing tumor cells. Target cells/pathways: HER2 on tumor cells (including HER2-mutant NSCLC, expansion in HER2+ gastrointestinal tumors) and the PD-1/PD-L1 immune checkpoint on tumor and immune cells/T lymphocytes.