What this study is
This Phase I, single-institution, open-label study will evaluate the safety, tolerability, and diagnostic performance of [18F]NOTA-ABY030 PET/CT in patients with head and neck squamous cell carcinoma (HNSCC) who present with indeterminate lesions on standard imaging. The investigational agent is a radiolabeled anti-EGFR affibody designed for rapid clearance and improved tumor-to-background contrast. All participants will receive a 50 mg cetuximab loading dose followed by a bolus of [18F]NOTA-ABY030, with PET/CT imaging performed at defined intervals to assess biodistribution and lesion uptake. The primary objective is to determine safety and tolerability; secondary objectives include radiation dosimetry and comparison of sensitivity and specificity to conventional imaging modalities (MRI, CT, and [18F]FDG-PET/CT). This approach aims to improve diagnostic accuracy, reduce unnecessary biopsies, and streamline treatment decisions for patients with HNSCC.
What's being tested
- Cetuximab (EGFR inhibitor)
Intervention · DRUG
Given IV
- 18F-NOTA-ABY-030
Intervention · DRUG
Given Bolus Injection
- Positron Emission Tomography (PET)
Intervention · PROCEDURE
Undergo PET/CT
Study details
- Sponsor
- Vanderbilt-Ingram Cancer Center
- Conditions
- SCC - Squamous Cell Carcinoma · Radiotracer · Head and Neck Squamous Cell Carcinoma · Metastatic Head and Neck Squamous Cell Carcinoma
- Enrolling
- 25 people
- Starts
- 2026-04-24
- Est. completion
- 2030-09
- Design
- Open-label, non-randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age ≥ 18 years.
- Subjects diagnosed with any T stage, any subsite within the head and neck. Subjects with recurrent disease or a new primary will be allowed.
- Must have evidence of indeterminate metastatic and/or primary SCC based on clinical imaging or Primary SCC with suspicious Lymph Nodes standard image modalities prior to surgical removal
- Have acceptable lab values, including the following clinical results (if values are considered clinically significant per investigator, participants must be asymptomatic):; Hemoglobin ≥ 9gm/dL; White blood cell count > 3000/mm3; Platelet count ≥ 100,000/mm3; Serum creatinine ≤ 1.5 times upper reference range; Potassium; Magnesium 7. Phosphorus
You can't join if
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
- Prior severe infusion reactions or hypersensitivity to other monoclonal antibody therapies.
- Pregnant (based on Screening serum or urine pregnancy test administered before infusions), or breastfeeding.
- Participants with known hypersensitivity to NOTA-ABY-030, cetuximab, murine, or any of the drug components used in this trial.
- Subjects with history or evidence of interstitial pneumonitis or pulmonary fibrosis.
- Severe renal disease or anuria.
- Participants presenting with a baseline QTcF interval > than 480 milliseconds.
- Those with an allergy to red meat, a history of tick bites, and alpha-gal syndrome will be given extra consideration.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openVanderbilt University Medical Center
Nashville, Tennessee, United States
- Nicole Jones · Contact615-936-2807nicole.l.jones@vumc.org
- Makenna Brown · Contact615-421-4370makenna.l.brown@vumc.org
- Eben Rosenthal, MD · Principal investigator
Recruiting
Study team
Sponsor
Vanderbilt-Ingram Cancer Center
Study ID VICCHNP25055
Principal investigator
Eben Rosenthal, MD
Vanderbilt University Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.