eligibility_summary
Adults ≥18 with HER2− metastatic breast cancer from GD2‑associated subtypes (e.g., TNBC), archival primary block required. RECIST‑measurable disease, ≥1 prior metastatic therapy, ECOG 0–1, adequate marrow/renal/hepatic. Controlled HIV/HBV/HCV allowed, contraception required. Exclude: WD NETs, recent therapy (<3 wks), active brain/lepto mets, recent other cancer, severe allergy/illness, new bone‑agent start near C1D1, autoimmune/immunosuppression/steroids, pregnancy, major cardiac/myocarditis, live vaccine <30 d, poor lungs.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase 1b/2 (NCT06026657) in metastatic GD2-expressing, HER2-negative breast cancer tests: 1) Gemcitabine—small-molecule antimetabolite (nucleoside analog). Mechanism: phosphorylated metabolites inhibit ribonucleotide reductase and DNA synthesis/produce DNA chain termination, killing proliferating tumor cells. 2) Ex vivo expanded allogeneic “universal donor” TGFβ-imprinted NK cells—cell therapy. Mechanism: NK cytotoxicity (missing-self, perforin/granzyme) with resistance to TGF-β–mediated immunosuppression, can mediate ADCC via CD16. 3) Naxitamab (Danyelza)—anti-GD2 IgG1 monoclonal antibody. Mechanism: binds GD2 to promote ADCC and complement-mediated cytotoxicity. Targets/pathways: GD2 on tumor cells, NK effector function and FcγRIIIa/CD16 ADCC axis, TGF-β suppressive signaling in NK cells, tumor DNA replication machinery.