eligibility_summary
Inclusion: ≥18, histologically confirmed advanced/metastatic salivary duct carcinoma, HER2 IHC 1+/2+/3+, ECOG 0–1, life expectancy >3 mo, ≥1 RECIST-measurable lesion, contraception per protocol (neg preg test), adequate marrow, liver, renal (CrCl ≥60 or Cr ≤1.5×ULN), cardiac (NYHA<3, LVEF≥50%). Exclusion: prior HER2 ADC/investigational Rx, surgery/live vaccine ≤4 wk, CV disease/thromboembolism, active infection/TB/HIV, HBV/HCV viremia, RC48 allergy, unstable disease, pregnant/breastfeeding/planning
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II multi-arm open-label trial in HER2-expressing salivary duct carcinoma tests vedicitumomab (Edisil/RC48), a humanized anti-HER2 antibody–drug conjugate (ADC) linked to MMAE, alone or with: (1) pyrrolitinib, an oral HER2 tyrosine-kinase inhibitor (TKI), (2) platinum chemotherapy (cisplatin/carboplatin, DNA cross-linkers), or (3) tremelimumab, an anti-CTLA-4 immune checkpoint antibody. Mechanisms: RC48 binds HER2, internalizes, and releases MMAE to disrupt microtubules causing cell-cycle arrest/apoptosis, may also mediate ADCC. Pyrrolitinib inhibits HER2/ErbB signaling (PI3K/AKT/MAPK). Platinums induce DNA damage. Tremelimumab blocks CTLA-4 to enhance T-cell activation. Targets: HER2 on SDC tumor cells, microtubules, tumor DNA, and CTLA-4 on T cells. Biomarker exploration: HER2 IHC/FISH, AR, EGFR, Ki-67, PD-L1, TILs/Tregs, ctDNA, HER2 ECD.