eligibility_summary
Adults 18–75 with advanced/metastatic solid tumors lacking standard options, expansion: NSCLC post 3rd‑gen EGFR TKI + platinum, HER3+ breast cancer after failure, or recurrent/metastatic HNSCC after failure. Requires RECIST-measurable disease, no prior HER3 or topo I inhibitors, ECOG 0–1, ≥3‑mo survival, adequate organs, contraception, consent. Exclude untreated CNS disease, recent major therapy/surgery, unresolved toxicity, immunosuppression, active HBV/HCV/HIV, bleeding risk, symptomatic effusions, serious/uncontrolled comorbidities, severe allergies, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: SIBP-A13 (HER3-ADC) given by IV, a HER3-targeted antibody‑drug conjugate in Phase 1 3+3 dose escalation/expansion (1–8 mg/kg, q3w) to define MTD/RP2D and assess safety, PK, immunogenicity, and preliminary efficacy. Mechanism of action: an anti‑HER3 (ERBB3) monoclonal antibody binds HER3 on tumor cells, is internalized, and releases a cytotoxic payload, trial exclusions (no prior topoisomerase I inhibitors/ADCs) indicate a topo I–inhibitor payload that induces DNA damage and apoptosis. Targets: HER3-expressing solid tumors and the EGFR/ERBB signaling axis, cohorts include EGFR‑mutant NSCLC post 3rd‑gen TKI/platinum, HER3+ breast cancer, and advanced HNSCC. Pathways/cells: HER3+ tumor cells, topoisomerase I/DNA replication machinery.