eligibility_summary
Adults (≥18) with incurable recurrent/metastatic HNSCC, consent, measurable disease (RECIST 1.1), ECOG 0–1, tumor tissue sent to a CLIA lab for CLDN1, PD‑L1 and biomarker testing, HPV status (for oropharynx) available. Exclude: RT/other local therapy <2 wks or unresolved AEs, active CNS mets/meningitis, active immune skin disorders, confounding conditions, prior severe IO irAEs (select cohorts), prior PD‑1/PD‑L1/PD‑L2 (Phase II combo), PD ≤6 mo after curative systemic tx (Phase II combo).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I/II open-label study (terminated) in recurrent/metastatic HNSCC testing: 1) ALE.C04, an anti–claudin-1 (CLDN1) monoclonal antibody (mAb), as monotherapy and combined with pembrolizumab, 2) Pembrolizumab alone (phase II comparator). Mechanisms: ALE.C04 targets CLDN1, a tight-junction protein commonly upregulated on tumor cells and in the tumor microenvironment, the mAb is intended to inhibit CLDN1-driven pro-tumor signaling and invasion and may enable immune effector engagement against CLDN1+ cells. Pembrolizumab is an anti–PD-1 IgG4 checkpoint inhibitor that blocks PD-1 on T cells to restore antitumor immunity. Targeted cells/pathways: CLDN1 on tumor/tumor-stroma, PD-1/PD-L1 axis on T cells and tumor/immune cells.