eligibility_summary
Adults ≥18 with locally advanced/metastatic prostate adenocarcinoma, PCWG3 progression on continuous ADT, testosterone ≤50 ng/dL, HER2 positive (IHC 1–3+, amplification or mutation), prior ARPI with progression, adequate labs, LVEF ≥50%, ECOG 0–1, life ≥6 mo, consent. Exclude: recent anticancer therapy, surgery or RT, CNS mets or meningitis, prior anti‑HER2, unresolved >G1 AEs, serious infection or HBV/HCV/HIV, major CVD, ≥G2 neuropathy, uncontrolled disease/malignancy, allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase II, single‑arm study of disitamab vedotin (RC48) in HER2‑expressing (IHC ≥1+) locally advanced/metastatic castration‑resistant prostate cancer after ADT and novel AR‑targeted therapy. Intervention/drug type and MOA: Disitamab vedotin is an antibody–drug conjugate (ADC) composed of an anti‑HER2 humanized monoclonal antibody linked to the cytotoxic payload MMAE (monomethyl auristatin E), a microtubule inhibitor. After binding HER2 (ERBB2) on tumor cells, the ADC is internalized, MMAE is released intracellularly to disrupt microtubules, causing G2/M arrest and apoptosis. The antibody component may also mediate ADCC and inhibit HER2 signaling. Dosing: 2.0 mg/kg IV every 2 weeks. Targets/cells/pathways: HER2‑expressing prostate cancer cells, ERBB2/HER2 receptor tyrosine kinase pathway, cytoskeletal/microtubule network, potential bystander killing of adjacent tumor cells. Aim: assess safety, efficacy, and PK.