eligibility_summary
Eligible: adults ≥18 with advanced/metastatic solid tumors post/without standard therapy, measurable disease, life expectancy ≥3 mo, ECOG 0–1, LVEF ≥50%, adequate organs/washout, tumor sample for HER3, contraception (F 7 mo, M 4 mo). Exclude: prior HER3 or topo I ADC, major cardiac/ECG/QTc issues or QT‑prolongers, ILD/pneumonitis or serious lung disease, active infection, pregnant/lactating, unstable brain mets, unresolved >G1 AEs, HIV/viral hepatitis, hypersensitivity, other safety risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1/2a first-in-human trial of DB-1310, a HER3 (ERBB3)-targeting antibody–drug conjugate (ADC) that delivers a topoisomerase I inhibitor payload (IV, Q3W). Tested as monotherapy and in combinations: trastuzumab (HER2 monoclonal antibody) and osimertinib (EGFR small‑molecule TKI). Mechanisms: DB-1310 binds HER3 on tumor cells, internalizes, and releases a DNA‑damaging topo‑I payload to kill HER3‑expressing cancer cells, trastuzumab blocks HER2/HER3 signaling, osimertinib inhibits mutant EGFR signaling. Targets/pathways: HER3/ERBB family (HER3, HER2, EGFR), downstream PI3K/AKT and MAPK. Indications include NSCLC (EGFR-mutant or KRAS-mutant), HER2+ breast cancer, CRPC, HNSCC, ESCC, and BTC.