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eligibility_summary
Include: histologically confirmed advanced/metastatic CRC or SCCHN that progressed after >=1 line of standard therapy. For CRC: prior bevacizumab- or cetuximab-based combinations, 5-FU regimens, or checkpoint inhibitors. For SCCHN: prior cetuximab (+/- other agents), checkpoint inhibitors (+/- other agents), or regimens with radiotherapy. Must have received all eligible targeted therapies. No limits by mutation status or EGFR. Exclude: prior cetuximab toxicity requiring permanent discontinuation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1b trial in advanced/metastatic CRC and SCCHN testing: (1) WU-NK-101: a biological cell therapy—non-engineered, allogeneic, cytokine-reprogrammed “memory-like” NK cells expanded ex vivo, (2) Cetuximab: a drug—chimeric IgG1 monoclonal antibody against EGFR. Mechanisms: WU-NK-101 provides potent innate tumor killing (perforin/granzyme), cytokine secretion, and antibody-dependent cellular cytotoxicity (ADCC) via CD16 (FcγRIIIa). Cetuximab binds EGFR, blocks ligand-induced signaling (RAS/RAF/MEK/ERK, PI3K/AKT), and opsonizes tumor cells to enhance NK cell ADCC. Targets: activated NK cells (memory-like phenotype), the ADCC pathway (CD16/Fc), and EGFR on tumor cells in CRC/SCCHN. Combination aims to amplify NK-mediated killing of cetuximab-coated, EGFR-expressing cancer cells.