eligibility_summary
Adults ≥18 with unresectable/metastatic solid tumors, provide tissue for HER3/molecular testing. ECOG 0–1, measurable lesion, adequate organs. Cohorts: HER3+ BC (HR+/HER2− or HER2+, pretreated), EGFR+ NSCLC after TKI+platinum, HER3+ platinum‑resistant ovarian, other driver+ NSCLC after TKI, other HER3+/NRG1+ tumors. Exclude unstable CNS mets, prior HER3‑ADC, unresolved AEs, recent therapy/surgery, active infection, HBV/HCV/HIV, cardiac/QTc disease, ILD, GI risk, strong CYP3A/OATP, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: SYS6023, a HER3 (ERBB3)-targeted antibody–drug conjugate (ADC, targeted biologic) given IV every 3 weeks. Mechanism of action: The monoclonal antibody binds HER3 on tumor cells, is internalized, and releases a cytotoxic payload to directly kill HER3-expressing cells, by engaging HER3-containing ERBB dimers (HER3–EGFR and HER3–HER2), it aims to suppress downstream PI3K–AKT/MAPK signaling often driven by heregulin (NRG1) and implicated in resistance to EGFR/HER2 therapies. Cells/pathways targeted: HER3+ tumor cells and ERBB signaling networks across multiple cohorts—HR+/HER2– and HER2+ breast cancer, EGFR-mutant NSCLC, other driver-positive NSCLC post-TKI, HER3+ platinum-resistant ovarian cancer, and other HER3+ tumors including NRG1 fusions. Primary focus: safety/tolerability, PK, and preliminary efficacy (dose 0.5–6.5 mg/kg, then expansion).