eligibility_summary
Adults (≥18) with histologically confirmed metastatic prostate cancer, ECOG 0–2, on continuous ADT (testosterone ≤50 ng/dL) with progression ≤6 months, prior ≥1 NHT, HER2 IHC 1–3+, unable/unwilling for docetaxel, life expectancy ≥6 mo, adequate organ function, consent. Exclude other cancers, allogeneic transplant, immunodeficiency, allergy to RC48/paclitaxel/antibodies/excipients, major abnormalities, unwilling contraception, active brain mets.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Disitamab Vedotin (RC48-ADC), an anti-HER2 antibody–drug conjugate (humanized IgG1) dosed IV every 2 weeks. Mechanism: binds HER2 (ERBB2) on tumor cells, is internalized, and a cleavable linker releases MMAE (monomethyl auristatin E), a microtubule inhibitor that causes G2/M arrest and apoptosis, the IgG1 Fc can also trigger ADCC, and released MMAE may exert a bystander effect. Targets: HER2-expressing metastatic castration-resistant prostate cancer cells (IHC 1+/2+/3+). Pathways affected: HER2 signaling (PI3K/AKT, MAPK), microtubule dynamics/mitosis, and immune effector (Fcγ-mediated) killing.