A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma

Active:	No
Cancer Type:	Head and Neck Cancer Skin Cancer (Non-Melanoma) Unknown Primary	NCT ID:	NCT03978689
Trial Phases:	Phase I	Protocol IDs:	Cue-101-01 (primary) NCI-2019-04589
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Cue BioPharma
NCI Full Details:	http://clinicaltrials.gov/show/NCT03978689

Summary

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 as monotherapy treatment in
second line or CUE-101 Combination Therapy with Pembrolizumab in first line patients with
HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Objectives

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 Part A&B, first-in-human trial, are to assess the safety and
tolerability of CUE-101 in subjects with recurrent/metastatic HNSCC in the second line
setting 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. The goal of
Part C&D is to characterize the safety, tolerability, and biological effects of CUE-101 in
combination with pembrolizumab in patients with recurrent/metastatic HNSCC in the first line
setting. This will be an open-label multicenter phase I trial conducted in the U.S. involving
approximately 85 patients.

Treatment Sites in Georgia

Emory University Hospital - Atlanta
1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

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