eligibility_summary
Adults ≥18 with unresectable, locally advanced HER2+ (IHC 1–3+) solid tumors, ineligible for/refusing SOC chemoradiation, consent, no prior systemic/RT, RECIST-measurable, ECOG 0–1, survival ≥12 wks, adequate organ function, effective contraception/negative pregnancy. Exclude prior anti-tumor therapy, recent major surgery, active HBV DNA/HCV RNA+/HIV, live vaccine <4 wks, NYHA ≥3, ≤1 yr thrombo/CV events, active infection, uncontrolled disease/autoimmunity, other cancer <5 yrs, prior ADC, allergy, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05940896 tests disitamab vedotin (RC48-ADC) plus radiotherapy in unresectable, locally advanced HER2-expressing solid tumors. Disitamab vedotin is an anti-HER2 IgG1 antibody-drug conjugate linked to MMAE (a microtubule inhibitor). Mechanism: binds HER2 (ERBB2) on tumor cells, internalizes, releases MMAE to disrupt tubulin polymerization, causing mitotic arrest and apoptosis, may also trigger ADCC and bystander killing. Radiotherapy provides ionizing radiation to induce DNA double-strand breaks and immunogenic cell death. Targets/pathways: HER2-positive tumor cells, ERBB2 surface receptor, microtubules/mitotic machinery, DNA damage response/repair pathways.