eligibility_summary
Include: Adults 18–75 with ECOG 0–1, adequate organ function. Newly diagnosed FIGO III–IV high‑grade serous ovarian/fallopian/primary peritoneal cancer with HER2 IHC ≥1+ or ERBB2 amplification, not candidates for primary debulking, measurable disease. Exclude: non‑HGS histology, CNS mets, uncontrolled effusions, serious cardiac/CNS/ILD/liver/GI disease, recent major surgery, bleeding disorders, other active cancer, prior HER2 or ovarian therapy, hypersensitivity, pregnancy/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 single-arm neoadjuvant study in stage III–IV HER2-expressing epithelial ovarian cancer tests: 1) RC48 (disitamab vedotin), a HER2-directed antibody–drug conjugate (humanized anti-HER2 monoclonal antibody linked via a cleavable linker to monomethyl auristatin E, a microtubule inhibitor), and 2) carboplatin, a platinum-based chemotherapy that forms DNA crosslinks. Mechanisms: RC48 binds HER2/ERBB2 on tumor cells, is internalized, and releases MMAE to inhibit tubulin polymerization, causing mitotic arrest and apoptosis, carboplatin induces DNA damage via intra/interstrand crosslinks. Targets: HER2-positive ovarian cancer cells, HER2/ERBB2 surface receptor, microtubules/mitotic machinery, and DNA damage pathways. Aim: increase complete resection and pathological complete response and delay recurrence.