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eligibility_summary
Include: unresectable/metastatic, refractory/ineligible for standard therapy, histologic cancer, measurable disease, ECOG 0–1, adequate organs. Part 1: breast, cholangio, colorectal, esophageal, gastric/GEJ, HNSCC, NSCLC, melanoma, ovarian, RCC, pancreatic, STS. Exclude: autoimmune disease or immunosupp, CNS mets, HIV, HBV/HCV, prior solid organ/allo‑HSCT, severe prior IO or (1C) EGFR mAb tox, unstable CV, surgery <4 wks, anticancer <4 wks/investigational <28 d, prior ILT3, live vax <28 d.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, open-label trial of BND-35 given IV every 2 weeks alone or with nivolumab or cetuximab in advanced solid tumors. BND-35 is a monoclonal antibody that targets ILT3 (LILRB4), an inhibitory receptor on myeloid cells (dendritic cells, monocytes/macrophages, MDSCs), blocking this myeloid checkpoint is intended to reprogram suppressive myeloid cells, increase antigen presentation, and enhance T-cell priming. Combinations: nivolumab (anti–PD-1 monoclonal antibody) to restore exhausted T-cell function via PD-1/PD-L1 blockade, cetuximab (anti-EGFR IgG1 monoclonal antibody) to inhibit EGFR signaling on tumor cells and promote Fc-mediated ADCC. Targets: ILT3+ myeloid cells, PD-1 on T cells, EGFR on tumor cells, downstream activation of CD8+ T cells and NK-cell cytotoxicity.