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)
Skin Cancer (Non-Melanoma)
18 Years and older, Male and Female
This is a multi center, open-label, phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect, and immunogenicity of CUE-101 in patients with recurrent / metastatic head and neck squamous cell carcinoma (HNSCC).
CUE-101 is a novel fusion protein designed to activate and expand a population of tumor
specific T cells to eradicate human papilloma virus (HPV)-driven malignancies. HPV causes
multiple tumor types including cervical, head and neck squamous cell carcinoma (HNSCC) and
anal cancers. Initial testing of CUE-101 will be conducted in HPV16+ HNSCC patients.
The primary objectives of the first-in-human trial are to assess the safety and tolerability
of CUE-101 in subjects with recurrent/metastatic HNSCC and to determine the maximum tolerated
dose or recommended Phase 2 dose based on markers of biological activity. Pharmacokinetics
(PK), antitumor immune response, preliminary antitumor activity and the potential for
immunogenicity will also be assessed. This will be an open-label multicenter phase I trial
conducted in the U.S. involving approximately 50 patients.