eligibility_summary
Include: Adults ≥18 with recurrent/metastatic HNSCC at specified subsites (EBV− nasopharynx only), progressed after PD-(L)1, measurable disease, ECOG 0–1, adequate organ function, washout ≥21 d/5 half-lives. Exclude: paclitaxel allergy, EBV+ NPC or sinonasal/salivary/skin SCC, >1 prior R/M line (no prior taxane/cetuximab in R/M), neuropathy >G1, uncontrolled HIV, steroids >10 mg/d, strong CYP2C8/3A4 drugs, active brain mets, recent trial, pregnancy/breastfeeding/egg plans.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 randomized trial in recurrent/metastatic HNSCC (post–PD-1/PD-L1 therapy) testing FID-007 plus cetuximab. FID-007: nanoencapsulated paclitaxel (polyethyloxazoline polymer), cytotoxic taxane that binds beta-tubulin, stabilizes microtubules, causes G2/M arrest and apoptosis, nanoformulation aims to enhance tumor delivery via EPR and reduce solvent-related toxicity. Cetuximab: chimeric IgG1 monoclonal antibody against EGFR, blocks ligand binding and receptor activation, inhibiting RAS/RAF/MEK/ERK and PI3K/AKT signaling, and mediates ADCC. Targets/pathways: proliferating tumor cells’ microtubules, EGFR-overexpressing HNSCC cells, downstream mitogenic/survival pathways, FcγR-bearing immune effector cells (ADCC). Regimens: FID-007 75 vs 125 mg/m2 IV D1/8/15 q28d plus cetuximab 500 mg/m2 IV q2w starting Cycle 2.