Study on Three Schedules of CUE-101 Before Surgery or Chemoradiation in Patients with Advanced HPV16-Positive Throat Cancer

Sponsor: Washington University School of Medicine

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04852328

Provider View

This clinical trial is testing the safety and effects of three different schedules of the drug CUE-101 given before standard treatment in patients with advanced HPV16-positive throat cancer. The study aims to see how well the drug works and is tolerated by patients.

Patient Parameters

Program Overview

This phase 2 study is exploring the safety and tolerability of three different schedules of the drug CUE-101, given before standard treatment, in patients who are newly diagnosed with advanced HPV16-positive throat cancer. The trial is for patients who have not yet received any treatment and are HLA-A*0201 positive. The study will collect blood and tumor samples before and after CUE-101 administration to assess its effects. After receiving CUE-101, patients will continue with their standard treatment as decided by their doctor.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with squamous-cell carcinoma of the throat or a neck mass suspected to be throat cancer.
  • Cancer stage I-III, except for specific early stages.
  • Eligible for standard treatment, either surgery followed by additional therapy or chemoradiation.
  • Positive for HLA-A*0201 genetic marker.
  • Tumors must test positive for HPV16 and show specific protein expression.
  • Provide a tumor tissue sample for eligibility.
  • At least 18 years old.
  • Good overall health with a performance status of 0 or 1.
  • Normal blood and organ function, including:
    • Platelets ≥ 100,000/mcl
    • Hemoglobin ≥ 9.0 g/dL
    • Neutrophil count ≥ 1,500/mcl
    • Liver enzymes and bilirubin within specified limits
    • Creatinine < 1.5 mg/dL or clearance >30 mL/min
  • Agree to use effective contraception during the study.
  • Able to understand and sign informed consent.

Exclusion Criteria

  • Previous bone marrow, stem-cell, or organ transplant.
  • Cancer that has spread to distant parts of the body.
  • Prior radiation or cancer treatment before the study drug.
  • Use of high-dose steroids or immune suppressive drugs recently.
  • Significant heart disease or recent heart events.
  • Lung issues requiring oxygen.
  • Serious digestive disorders or recent bleeding.
  • Active infections needing treatment recently.
  • History of hepatitis B or C, unless treated and in remission.
  • Another cancer not in remission for over 2 years, with some exceptions.
  • Previous radiation to the head and neck.
  • Major surgery recently.
  • Serious medical conditions affecting treatment.
  • Allergies to study drug components.
  • Recent live virus vaccination.
  • Substance abuse issues recently.
  • Pregnant or breastfeeding women.

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