eligibility_summary
Inclusion: Adults 18-75 with unresectable locally advanced/recurrent/metastatic HER2+ (IHC3+ or FISH+) breast cancer, ≤2 prior chemo lines (excluding endocrine), measurable disease (RECIST 1.1), recovered AEs (≤G1), adequate marrow/liver/renal/coag, ECOG 0-1, consent. Exclusion: ARX788 allergy, active/meningeal brain mets, symptomatic effusions, ILD/pneumonitis, eye disease needing treatment, cardiac insufficiency, uncontrolled HTN, severe systemic disease, live vaccine <4 wks, pregnant/breastfeeding or no contraception, unwilling to stop contact lenses, recent systemic therapy <28 d/5 half-lives (endocrine allowed ≥7 d gap), cognitive disorder, other investigator judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Single-arm Phase 2 in HER2-positive metastatic breast cancer. Intervention: ARX788 (drug), an anti-HER2 antibody–drug conjugate (ADC) given IV every 6 weeks (2.2 mg/kg). Mechanism: The monoclonal antibody targets and binds HER2 on tumor cells, is internalized, and releases a site-specific auristatin-derived microtubule inhibitor (Amberstatin-269), disrupting tubulin polymerization to induce G2/M arrest and apoptosis. The antibody component may also inhibit HER2 signaling and mediate ADCC. Targets: HER2/ERBB2-expressing breast cancer cells, HER2 signaling axis (PI3K/AKT/MAPK), microtubule cytoskeleton, Fc-mediated immune effector cells (e.g., NK via FcγR).