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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)

Cancer Type
Skin Cancer (Non-Melanoma)
Unknown Primary
Trial Phase
Phase I
18 Years and older, Male and Female
Study Type
Protocol IDs
Cue-101-01 (primary)
Study Sponsor
Cue BioPharma


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.
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