eligibility_summary
Eligibility: consent, LVEF≥50%, ECOG 0–1, life ≥3 mo, advanced/unresectable/metastatic solid tumors. Cohorts: A breast, HER2‑low (IHC 1+ or 2+/ISH−), HR+ endocrine‑refractory, never HER2+. B endometrial, HER2 IHC 1+/2+/3+, ≥1 platinum, no prior ADC. C HER2‑overexpressed/mutant tumors. Exclude: prior topo‑I ADC, recent surgery/therapy, other cancer <3y, symptomatic CNS mets, unresolved >G2 AEs, cardiac/QTc disease, ILD, infection, allergy, substance abuse, pregnant/lactating, poor compliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: FDA022-BB05, an intravenous HER2‑targeted monoclonal antibody–drug conjugate (ADC) dosed 5.4 mg/kg every 3 weeks. Mechanism of action: the antibody binds HER2 (ERBB2) on tumor cells, is internalized, and releases a cytotoxic payload that damages DNA and inhibits proliferation, leading to tumor cell death, designed to work in HER2‑expressing and HER2‑low settings. Targets: HER2‑expressing/overexpressing or mutant tumor cells and the HER2 signaling axis across metastatic/recurrent breast (HER2‑low), endometrial (HER2 1+/2+/3+), and other HER2‑altered solid tumors (e.g., urothelial, colorectal, NSCLC).