eligibility_summary
Eligibility: Adults ≥18 with advanced/metastatic solid tumor with confirmed NRG1 fusion, ≥1 measurable lesion (RECIST 1.1), ECOG 0–1, able to provide adequate tumor tissue, and adequate labs: Plt ≥100k, Hgb ≥9, ANC ≥1.5k, CrCl ≥30 or SCr ≤1.5×ULN, AST/ALT ≤3×ULN (≤5× w/ liver mets), bili ≤1.5×ULN, albumin ≥2.5. Exclude ILD/severe lung disease, systemic steroids >10 mg, CNS disease, inadequate washouts, prior HER3/topo I/ADC, unresolved tox, recent other cancers, major CV disease, active HBV/HCV.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Patritumab deruxtecan (U3-1402), a HER3-directed antibody–drug conjugate (ADC). Mechanism: a fully human anti-HER3 (ERBB3) IgG1 linked via a cleavable linker to deruxtecan (DXd), a topoisomerase I inhibitor. It binds HER3, can inhibit NRG1–HER3 signaling, is internalized, and releases DXd to induce DNA damage/apoptosis, with potential bystander effect. Design: Phase 2, single-arm basket, 5.6 mg/kg IV every 3 weeks in advanced solid tumors with NRG1 fusions. Cells/pathways targeted: NRG1 fusion–driven, HER3-expressing tumor cells, ERBB3/ERBB4 with heterodimerization to EGFR/HER2, downstream PI3K–AKT and MAPK pathways, topo I–dependent DNA replication.