eligibility_summary
Eligibility: Adults ≥18 with ECOG 0–1, life expectancy ≥12 weeks, adequate marrow/organ function, and histologically/cytologically confirmed unresectable, locally advanced or metastatic solid tumor refractory/intolerant to, or lacking, standard therapy. Exclusions: participation in other interventional trials, prior HER3-targeted therapy, prior exatecan-derived topoisomerase I inhibitor ADC (e.g., DS-8201).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
- Intervention: IBI133 (biologic, antibody‑drug conjugate). First‑in‑human, Q3W monotherapy. - Mechanism of action: An anti‑HER3 (ERBB3) monoclonal antibody conjugated to a topoisomerase I–inhibiting exatecan‑derivative payload. It binds HER3 on tumor cells, is internalized, and releases the cytotoxic payload to inhibit topo I, causing DNA damage and tumor cell death, may also dampen HER3 signaling. - Cells/pathways targeted: HER3‑expressing solid tumor cells, ERBB3/ERBB family signaling (downstream PI3K/AKT), DNA replication machinery via topoisomerase I inhibition.