eligibility_summary
Includes: consent, LVEF≥50%, ECOG 0–1, life expectancy≥3 mo, adequate blood/coag/renal/hepatic labs, measurable disease, prior toxicities ≤Grade1, contraception and negative pregnancy test, Part 1: refractory advanced solid tumors, Part 2: HER2+ breast (≥1 prior HER2 therapy) or HER2+ gastric/GEJ (≥2). Excludes: prior topo‑I ADC, recent therapy/major surgery, other recent cancers, symptomatic CNS mets, unresolved AEs, serious CV/QTc, ILD, active infection, HIV/HBV/HCV, major comorbidity/allergy, substance abuse, pregnancy/lactation, poor compliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: First-in-human Phase 1 dose-escalation/expansion of FDA022-BB05 in advanced solid tumors, with expansion in HER2-overexpressing breast and gastric/GEJ cancers. Drug/Type/MOA: FDA022-BB05 is an intravenous HER2-targeted monoclonal antibody–drug conjugate (ADC) dosed q3w. It binds HER2 on tumor cells, is internalized, and releases an intracellular cytotoxic payload to kill cancer cells, it may also contribute to HER2 pathway blockade and Fc-mediated effector functions. Targets: HER2-overexpressing tumor cells and the HER2 receptor tyrosine kinase pathway (breast, gastric/GEJ).