Actively Recruiting
Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma
Led by Washington University School of Medicine · Updated on 2026-05-05
30
Participants Needed
1
Research Sites
307 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
C
Cue Biopharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase 2 trial to assess the safety and tolerability of three schedules of CUE-101 administered in the neoadjuvant phase before standard of care (SOC) therapy to treatment naïve, HLA-A\*0201 positive patients with newly diagnosed, locally advanced HPV16+ oropharyngeal squamous-cell carcinoma (OPSCC). This is an exploratory trial of a limited sample size to confirm safety and to assess for pharmacodynamic signals of efficacy in each of three schedules of CUE-101. Safety assessments will be performed at baseline and after CUE-101 administration. To assess for efficacy, peripheral blood and tumor samples will be collected at baseline and after CUE-101 administration. Following CUE-101, patients will proceed with SOC therapy, as prescribed by the treating physician.
CONDITIONS
Official Title
Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed squamous-cell carcinoma of the oropharynx or upper neck mass suspected to be oropharynx based on clinical factors
- Stage I-III (AJCC 8th Edition) excluding clinical stages T1N0 and T2N0
- Candidate for standard of care therapy (surgery with adjuvant therapy or definitive chemoradiation) as decided by treating physician
- HLA-A*0201 genotype confirmed by genomic testing on blood
- Tumors positive for HPV16 by PCR or ISH and p16INK4A expression (>70% staining) by IHC
- Availability of archival or new tumor tissue sample suitable for eligibility determination
- At least 18 years old
- ECOG performance status of 0 or 1
- Normal bone marrow and organ function with specified lab values
- Agreement to use adequate contraception if of childbearing potential or male participant
- Ability and willingness to provide informed consent
You will not qualify if you...
- Prior allogeneic bone marrow, stem-cell, or solid organ transplantation
- Presence of distant metastases
- Previous radiation or systemic anti-cancer therapy before study drug administration
- Use of corticosteroids (>10 mg prednisone or equivalent) or immunosuppressive drugs within 14 days before study drug, except certain allowed forms
- Significant cardiovascular disease including recent myocardial infarction or unstable angina, arrhythmias, uncontrolled hypertension, recent thromboembolic events, QTc prolongation, congestive heart failure, pericarditis, or myocarditis
- Clinically significant pulmonary compromise requiring oxygen
- Significant gastrointestinal disorders including recent perforation, bleeding, pancreatitis, diverticulitis, or cirrhosis
- Active infections requiring parenteral treatment within 7 days of study drug
- Known hepatitis B or C infection unless treated and in remission >1 year
- Second primary invasive cancer not in remission >2 years with exceptions
- Prior head and neck radiation therapy
- Major surgery within 4 weeks before study drug administration
- Serious medical conditions impairing treatment tolerance
- Known hypersensitivity to recombinant proteins or excipients in CUE-101
- Vaccination with live virus vaccine within 4 weeks before study drug
- Active or recent uncontrolled alcohol or substance abuse within 3 months
- Pregnant or breastfeeding; women of childbearing potential must have negative pregnancy test within 72 hours of entry
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
J
Jesse Zaretsky, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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