eligibility_summary
Adults ≥18 with metastatic epithelial cancer after standard therapy failure: AGA+ NSCLC with driver mutation (EGFR/ALK/ROS1/NTRK/BRAF V600/METex14/RET/KRAS G12C/HER2, prior targeted + platinum±IO, osimertinib if T790M) or HER2 IHC0 BC. Need measurable disease, ECOG 0–1, LVEF ≥50%, adequate organs, survival ≥3 mo. Exclude unstable CNS mets, recent trial/therapy/surgery, significant GI/effusions, prior topo‑I ADCs, ILD, active infection (HIV/TB/syphilis), CV/QTc risks, recent thrombosis, unresolved tox, mAb allergy, severe eye disease, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase I, first-in-human, dose-escalation/expansion in advanced solid tumors (IV Q3W, 0.5–8 mg/kg). Intervention: JSKN016 injection—a bispecific antibody–drug conjugate (ADC). Type/mechanism: IgG-based bispecific ADC that simultaneously binds HER3 (ERBB3) and TROP2 on tumor cells, drives receptor-mediated internalization, and releases an intracellular cytotoxic payload to induce tumor cell death, dual targeting may also dampen HER3 signaling and address antigen heterogeneity. Targets (cells/pathways): HER3/ERBB signaling axis (NRG1→HER3 dimerization, downstream PI3K/AKT) and TROP2-overexpressing epithelial tumor cells implicated in proliferation and survival. Population focus: refractory/metastatic epithelial cancers, including AGA+ NSCLC and HER2 IHC0 breast cancer. Excludes prior topo I–ADC exposure (e.g., DS-8201, HER3-DXd, DS-1062).