eligibility_summary
Inclusion: ≥18, unresectable locally advanced/metastatic pancreatic cancer, HER2 IHC 1+, 2+, or 3+, therapy per cohort (C1: prior gemcitabine-free or gemcitabine intolerant, C2: prior second-line or intolerant), if prior curative chemo/RT, disease-free ≥6 mo, measurable RECIST 1.1 lesion, ECOG 0-1, life expectancy ≥3 mo, adequate organs, contraception, consent. Exclusion: symptomatic CNS/meningeal mets, autoimmune/immunodeficiency/HIV/transplant, active HBV/HCV/syphilis, major surgery/trauma <3 wks, drug allergy, recent strong P-gp/CYP3A4 modulators.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, parallel-arm study in HER2-expressing (IHC 1+/2+/3+) locally advanced/metastatic pancreatic cancer. Interventions: (1) Disitamab vedotin (RC48) + gemcitabine as 2nd line, (2) Disitamab vedotin monotherapy as 3rd line. Mechanisms: Disitamab vedotin is an antibody–drug conjugate (ADC) comprising a humanized anti‑HER2 monoclonal antibody linked to the microtubule inhibitor MMAE (vedotin). It binds HER2 (ERBB2) on tumor cells, is internalized, releases MMAE to disrupt microtubules causing cell-cycle arrest/apoptosis, and may mediate ADCC, targets HER2-driven signaling (PI3K/AKT/MAPK). Gemcitabine is a deoxycytidine analog (antimetabolite) that inhibits ribonucleotide reductase and incorporates into DNA, blocking DNA synthesis (S‑phase). Targets: HER2-positive pancreatic tumor cells, microtubules, DNA synthesis pathways.