Clinical Trials

CUE-101 is a novel fusion protein designed to activate and expand tumor-specific T cells that target Human Papilloma Virus 16 (HPV16)-driven malignancies. HPV16 causes multiple tumor types including head and neck squamous cell carcinoma (HNSCC), cervical and anal cancers.

A first in human study of CUE-101 will be conducted in eligible HNSCC patients. This open-label, multicenter Phase 1 trial will assess the safety and tolerability, preliminary antitumor activity and potential for an antitumor immune response upon CUE-101 treatment in patients with recurrent/metastatic HNSC.

For more information on the study, please visit