NCT07217028RecruitingPhase 1

Study Evaluating [18F]NOTA-ABY030 for Safety and Tolerability of Indeterminate Primary and/or Metastatic Disease in Head and Neck Squamous Cell Carcinoma

Source: ClinicalTrials.gov · Last updated 11 May 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 25 (estimated)
First submitted: 13 Oct 2025
Start date: 24 Apr 2026
Primary completion date: 30 Apr 2029
Lead sponsor: Vanderbilt-Ingram Cancer Center
Diseases: Head and neck cancer
NCT number: NCT07217028

What you commit to

Study type: Interventional · Phase 1
Planned participants: 25
From 24 Apr 2026 to the primary completion date, 30 Apr 2029
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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.

Other illness

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.
Those with an allergy to red meat, a history of tick bites, and alpha-gal syndrome will be given extra consideration.

Lab values

Pregnant (based on Screening serum or urine pregnancy test administered before infusions), or breastfeeding.

Other

Participants presenting with a baseline QTcF interval \> than 480 milliseconds.

Who the study is looking for

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
- Phosphorus

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Vanderbilt University Medical Center Coordinator of this site? Confirm its status	Nashville	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.