eligibility_summary
Adults (18+) with advanced/metastatic melanoma, SCCHN, HER2-neg gastric/GEJ, ovarian, cervical, endometrial, bladder, esophageal SCC, pancreatic, CRPC, nonsq NSCLC (no drivers), or HR+/HER2-neg breast, after required prior therapy (often incl anti-PD-(L)1 +/- platinum/chemo). Require measurable disease, ECOG 0-1, and tumor tissue. Exclude HER2+ gastric, nasopharynx, mucosal/uveal melanoma, ILD/pneumonitis, systemic steroids, prior anti-HER3/exatecan-ADC/topo-I, other active cancer, uncontrolled illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, open-label, single-arm study of patritumab deruxtecan (HER3-DXd, U3-1402), an antibody-drug conjugate. Drug type: fully human anti-HER3 (ERBB3) IgG1 monoclonal antibody linked via a cleavable linker to DXd, a membrane-permeable topoisomerase I inhibitor. Mechanism: binds HER3 on tumor cells, is internalized, then releases DXd intracellularly to inhibit topoisomerase I, causing DNA damage and cell death, payload can produce a bystander effect. Targets: HER3-expressing tumor cells across multiple previously treated solid tumors (melanoma, SCCHN, HER2− gastric/GEJ, ovarian, cervical, endometrial, bladder, esophageal, pancreatic, prostate, NSCLC, HR+/HER2− breast). Pathways affected: HER3-driven signaling and HER3 heterodimers (with EGFR/HER2), downstream PI3K/AKT and MAPK survival/proliferation pathways. Dosing: 5.6 mg/kg IV every 3 weeks. Study assesses efficacy, safety, PK, and correlation with HER3 expression.