eligibility_summary
Eligible: adults (≥18) with HER2+ (IHC ≥1+) mammary/extramammary Paget’s disease, ECOG 0–1, measurable/evaluable lesions, adequate marrow/liver/renal/coag function, and ≥3-month life expectancy. Exclude: immunodeficiency/HIV/organ transplant, active autoimmune or steroids >10 mg/d, TB, uncontrolled effusions, major surgery/trauma ≤28 d, live vaccine ≤14 d, severe allergy/mAb reaction, other trials ≤4 w, bleeding risk/thrombolytics, substance/psychiatric issues, or other safety concerns.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm trial testing disitamab vedotin (RC48) in advanced HER2-positive mammary or extramammary Paget’s disease. Drug/intervention: Disitamab vedotin (RC48), a HER2-directed antibody-drug conjugate (ADC). Mechanism: A humanized anti-HER2 IgG1 linked to the microtubule inhibitor MMAE (vedotin). After binding HER2 (ERBB2) on tumor cells, the ADC is internalized, MMAE is released to disrupt microtubules, inducing G2/M arrest and apoptosis, with possible bystander effect and Fc-mediated ADCC. Target cells/pathways: HER2-positive Paget cells (IHC ≥1+), HER2/ERBB2 signaling at the cell surface and microtubule/mitotic pathways intracellularly. Dosing: 2 mg/kg IV every 3 weeks until progression.