Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

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Source: NCT07217028

Not yet recruiting

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

Head and Neck Cancer

Phase 1

Vanderbilt University Medical Center

United States of America

Sponsor: Vanderbilt-Ingram Cancer Center

Last Updated: February 27, 2026
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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.

Study Type

Diagnostic

Radiation

Positron

Radiopharmaceutical

F-18 NOTA-ABY030

Target

EGFR

Trial Started

April 28, 2026

Last Updated by Sponsor

February 27, 2026

Estimated Completion

April 1, 2029

Eligibility

Inclusion Criteria

1. Age ≥ 18 years.

2. Subjects diagnosed with any T stage, any subsite within the head and neck. Subjects with recurrent disease or a new primary will be allowed.

3. 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

4. Have acceptable lab values, including the following clinical results (if values are considered clinically significant per investigator, participants must be asymptomatic):

1. Hemoglobin ≥ 9gm/dL

2. White blood cell count > 3000/mm3

3. Platelet count ≥ 100,000/mm3

4. Serum creatinine ≤ 1.5 times upper reference range

5. Potassium

6. Magnesium

7. Phosphorus

Exclusion Criteria

1. Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.

2. Prior severe infusion reactions or hypersensitivity to other monoclonal antibody therapies.

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

4. Participants with known hypersensitivity to NOTA-ABY-030, cetuximab, murine, or any of the drug components used in this trial.

5. Subjects with history or evidence of interstitial pneumonitis or pulmonary fibrosis.

6. Severe renal disease or anuria.

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

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

Design Details

AllocationNon-Randomized

Intervention ModelSequential Assignment

MaskingNone (Open Label)

Number to Enroll60

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: Cohort A will include a minimum of six participants up to 12 participants. These participants will receive a 50 mg intravenous infusion of cetuximab, followed by a bolus injection of [18F]NOTA-ABY-030 at a dose of 5 (±1) mCi. To evaluate tracer distribution and radiation exposure, participants in this cohort will undergo three whole-body PET/CT scans at specific timepoints: 0-90 minutes, 120 minutes, and 240 minutes post-injection. Each scan will cover the region from the skull to mid-thigh, with a total imaging time of approximately 90 minutes. This cohort is essential for determining the absorbed dose, organ-specific uptake, identification of critical organs, and the effective dose of the radiopharmaceutical. The data collected from Cohort A will inform safety parameters and support dose optimization for future clinical studies involving [18F]NOTA-ABY-030.

Interventions:

Cetuximab (EGFR inhibitor)
18F-NOTA-ABY-030
Positron Emission Tomography (PET)

Outcome Measures

Primary Outcome Measures

Assess number, grade and severity of adverse events to determine safety and tolerability of [18F]NOTA-ABY-030 in human subjects.From infusion to 7 days post-infusion

As determined by the number of adverse events (AEs) that are possibly or probably related to the study drug within 24 hours after infusion. Dose limiting toxicities will be defined as an AE grade >2 that is clinically significant and attributable to the study drug.

Secondary Outcome Measures

Determination of the radiation dosimetry for [18F]NOTA-ABY-030 in human subjects.From infusion to 7 days post-infusion

The dosimetry for [18F]NOTA-ABY-030 will be determined to be the absorbed dose, organ specific uptake, critical organs, and effective dose for this first-in-human radiopharmaceutical.

Compare sensitivity and specificity of standard of care imaging modalities (MRI, CT, and/or [18F]FDG PET/CT) to [18F]NOTA-ABY-030-PET/CT for detection of indeterminate metastatic and/or primary lesion(s) in HNSCCFrom infusion to 7 days post-infusion

The specificity and sensitivity of [18F]NOTA-ABY-030 will be compared to the specificity and sensitivity of standard of care imaging obtained (MRI, CT, and/or [18F]FDG PET/CT) for identification of metastatic or primary lesion.

Determine the sensitivity and specificity of [18F]NOTA-ABY-030 for the detection of indeterminate metastatic and/or primary lesion(s) in HNSCC.From day of infusion to 36 months post-infusion

The total number of HNSCC accurately detected by [18F]NOTA-ABY-030 compared to the number of positive disease during the 36 ± 6-month follow-up period (gold standard).

Trial Sites

This study has 1 trial site

Vanderbilt University Medical Center
Nashville, Tennessee, US

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