A Phase I Study of CUE-101 Immunotherapy in Patients with Recurrent or Metastatic HPV-Positive Head and Neck Cancer


Full Title

A Phase 1, First-In-Human, Open-Label, Dose Escalation and Expansion Study of CUE-101 Monotherapy in Patients With HPV+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)


The purpose of this study is to find the highest dose of the investigational immunotherapy CUE-101 that can be given safely in patients with head and neck cancers that have come back or spread despite chemotherapy. CUE-101 works by activating immune cells called T cells to recognize cancer cells containing proteins called HPV16 and HLA-A*0201. When CUE-101 identifies these markers on cancer cells, it can help the immune system destroy them. CUE-101 is given intravenously (by vein).


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have squamous cell carcinoma of the head and neck that came back or spread after prior chemotherapy that included a platinum-containing drug (such as cisplatin).
  • Patients’ tumors must be positive for HPV16 and HLA-A*0201 (to be evaluated when the patient inquires about the study).
  • At least 2 weeks must pass between the completion of prior treatment and receipt of CUE-101.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Lara Dunn at 646-608-3787.





Disease Status

Relapsed or Refractory