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

Completed · Phase 1

Conditions studied: Head and Neck Cancer, HPV Positive Oropharyngeal Squamous Cell Carcinoma, HPV-Related Carcinoma

In brief

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)

Key facts

Study ID

NCT03978689

Run by

Cue Biopharma

People needed

80

Starts

2019-07-30

Expected to finish

2026-01-04

Last updated by the study team

2026-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• General:
• 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.
• Age ≥18 years old
• ECOG performance status of 0 or 1
• Life expectancy ≥12 weeks
• Measurable disease as per RECIST 1.1 and documented by CT and/or MRI by the local site investigator/radiology. At least 1 lesion that can be accurately measured in at least 2 dimensions with spiral CT scan. Minimum measurement must be >15 mm in the longest diameter by >10 mm in the short axis. 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.
• All tumors must have histologically or cytologically confirmed diagnoses of recurrent and/or metastatic HNSCC.
• Patient must have HLA A*0201 genotype as determined by genomic testing performed at a central laboratory designated by the Sponsor prior to enrollment.
• Patient must have 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.
• Patient must have tumor expression of PD L1 (CPS ≥1) as determined by an FDA-approved test.
• Laboratory Features
• Acceptable laboratory parameters as follows:
• Platelet count ≥100 × 103/μL
• Hemoglobin ≥9.0 g/dL. Criteria must be met without erythropoietin dependency and without pRBC transfusion within last 2 weeks.
• Absolute neutrophil count ≥1.5 × 103/μL in the absence of any growth factor support within 2 weeks prior to the initiation of study drug
• ALT or AST ≤2.5 × ULN; for patients with hepatic metastases, ALT and AST ≤5 × ULN
• Total bilirubin ≤1.5 × ULN, except patients with Gilbert's syndrome, who may enroll if the conjugated bilirubin (total and direct) is within normal limits
• Creatinine ≤1.5 mg/dL, or a calculated or measured creatinine clearance ≥30 mL/min. Creatinine clearance should be calculated as per institutional standard. >1.5 x institutional ULN. Glomerular filtration rate (GFR) can also be used in place of creatinine or creatinine clearance.
• Coagulation: INR or PT ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within the therapeutic range of anticoagulants.
• Reproductive Features
• A male participant must agree to use contraception during the treatment period and for at least 120 days following discontinuation of study treatment.
• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
• Not a woman of childbearing potential (WOCBP)
• A WOCBP who agrees to follow contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.

You may not qualify if…

• Patients with symptomatic CNS metastases must have been treated, be asymptomatic, and not have any of the following at the time of enrollment:
• Need for concurrent treatment for the CNS disease (eg, surgery, radiation, corticosteroids >10 mg prednisone/day or equivalent);
• 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
• Concurrent leptomeningeal disease or cord compression.
• 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.
• History of prior allogeneic bone marrow, stem-cell or solid organ transplantation
• 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.
• Treatment with radiation therapy within 2 weeks prior to the initiation of study drug administration.
• 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.
• History of clinically significant cardiovascular disease including, but not limited to:
• Myocardial infarction or unstable angina within the 16 weeks prior to the initiation of study drug
• Clinically significant cardiac arrhythmias
• Uncontrolled HTN: systolic BP >180 mm Hg, diastolic BP >100 mm Hg
• Deep vein thrombosis, pulmonary embolism, stroke, or transient ischemic attack within the 16 weeks prior to the initiation of study drug
• QTcB prolongation >480 msec
• CHF (NY Heart Association Class III IV)
• Pericarditis/clinically significant pericardial effusion
• Myocarditis
• Clinically significant pulmonary compromise (eg, requirement for supplemental oxygen)
• Clinically significant GI disorders including:
• History of GI perforation within 1 year prior to study drug administration. Patients with a history of GI perforation that occurred more than 1 year ago can only be enrolled if the Investigator no longer considers the previously affected area to be at risk for perforation;
• History of clinically significant GI bleeding within 3 months prior to the initiation of study drug
• History of acute pancreatitis within 3 months prior to the initiation of study drug; and/or
• Diverticulitis that is clinically significant in the opinion of the investigator based on the extent or severity of known disease and/or the occurrence of clinically significant disease flares within 4 weeks prior to the initiation of study drug administration.
• Patients who experienced the following immune checkpoint inhibitor-related AEs are ineligible even if the AE resolved to ≤Grade 1 or baseline:

Where it is running

• 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
• Barbara Karmanos Cancer Center/ Wayne State University School of Medicine — Detroit, Michigan, United States
• Washington University — St Louis, Missouri, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Vanderbilt-Ingram Cancer Center (VICC) — Nashville, Tennessee, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• University of Washington School of Medicine — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.