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A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Phase1, First-in-Human, Open-Label, Dose Escalation and Expansion Study of CUE-101 Monotherapy in Second Line or CUE-101 Combination Therapy With Pembrolizumab in First Line Patients With HPV16+ Recurrent/Metastatic HNSCC

NCT03978689•Cue Biopharma

View on ClinicalTrials.gov

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)

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•General:
•1. Ability to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures that are not part of standard of care for the patient's disease. Patients must also be willing and able to comply with study procedures, including the acquisition of specified research specimens
•2. Age ≥18 years old
•3. ECOG performance status of 0 or 1
•4. Life expectancy ≥12 weeks
•5. Measurable disease as per RECIST 1.1 and documented by CT and/or MRI. Cutaneous or subcutaneous lesions must be measurable by calipers. Note: Lesions to be used as measurable disease for the purpose of response assessment must either a) not reside in a field that has been subjected to prior radiotherapy, or b) have demonstrated clear evidence of radiographic progression since the completion of prior radiotherapy and prior to study enrollment
•6. R/M HNSCC that has progressed following at least 1 prior systemic therapy. Patients must have received platinum-based chemotherapy and/or pembrolizumab in the first-line setting
•7. Patient must have HLA A\*0201 genotype as determined by genomic testing performed at a central laboratory designated by the Sponsor.
•8. Patient must have histologically and/or cytologically proven tumor(s) that are HPV16+ and express 16INK4A. Archival tissue or FFPE tissue from a biopsy and/or surgery must be available for HPV16 and p16INK4A testing on all patients enrolled. All tumors must test positive for both HPV16 using RNA ISH and p16INK4A expression in tumor cells using IHC analysis determined in a central laboratory designated by the Sponsor. All tumors must have histologically or cytologically confirmed diagnoses.
•Laboratory Features
+39 more criteria

Exclusion Criteria

•1. Patients with symptomatic CNS metastases must have been treated, be asymptomatic, and not have any of the following at the time of enrollment:
•1. Need for concurrent treatment for the CNS disease (eg, surgery, radiation, corticosteroids \>10 mg prednisone/day or equivalent);
•2. Progression of CNS metastases on MRI or CT for at least 28 days after last day of prior therapy for the CNS metastases; and/or
•3. Concurrent leptomeningeal disease or cord compression.
•2. Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
•3. History of prior allogeneic bone marrow, stem-cell or solid organ transplantation
•4. Treatment with any systemic anti-neoplastic therapy, or investigational therapy within the 2 weeks (or 4 weeks, for antibody drugs), prior to the initiation of study drug administration. Patients may be on an investigational or other anti-neoplastic therapy during the screening phase of the study.
•5. Treatment with radiation therapy within 2 weeks prior to the initiation of study drug administration.
•6. Treatment with corticosteroids (\>10 mg per day prednisone or equivalent) or other immune suppressive drugs within the 14 days prior to the initiation of study drug administration.
•7. History of clinically significant cardiovascular disease including, but not limited to:
+74 more criteria

Locations (17)

University of Arizona

Tucson, Arizona, United States

Stanford University Medical Center

Palo Alto, California, United States

Yale School of Medicine

New Haven, Connecticut, United States

George Washington University Cancer Center

Washington D.C., District of Columbia, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Affiliated Oncologists, LLC

Chicago, Illinois, United States

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Key Dates

Start Date

July 30, 2019

Primary Completion Date

January 4, 2026

Completion Date

January 4, 2026

Last Updated

January 22, 2026

Enrollment

ACTUAL participants

Conditions

Head and Neck CancerHPV Positive Oropharyngeal Squamous Cell CarcinomaHPV-Related Carcinoma

Interventions

CUE-101

DRUG

KEYTRUDA®, Pembrolizumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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