Study Evaluating [18F]NOTA-ABY030 for Safety and Tolerability of Indeterminate Primary and/or Metastatic Disease in Head and Neck Squamous Cell Carcinoma
1 other identifier
interventional
25
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2026
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2025
CompletedFirst Posted
Study publicly available on registry
October 15, 2025
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2030
April 29, 2026
February 1, 2026
3 years
October 13, 2025
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess number, grade and severity of adverse events to determine safety and tolerability of [18F]NOTA-ABY-030 in human subjects.
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.
From infusion to 7 days post-infusion
Secondary Outcomes (2)
Determination of the radiation dosimetry for [18F]NOTA-ABY-030 in human subjects.
From infusion to 7 days post-infusion
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 HNSCC
From infusion to 7 days post-infusion
Other Outcomes (1)
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
Study Arms (2)
Cohort 1 - Dosimetry (3 Whole Body PET/CT Scans)
EXPERIMENTALCohort 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.
Cohort 2 - (1 Whole Body PET/CT Scan)
EXPERIMENTALCohort 2 will include a minimum of thirteen participants. Each participant 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. Imaging for this cohort will be conducted at a single timepoint, approximately 0-240 minutes (±15 minutes) post-injection, based on optimized timing derived from Cohort 1 data. The PET/CT scan for Cohort 2 will cover the region from skull to chest, with a total scan time of approximately 30 minutes. This cohort is designed to evaluate the diagnostic performance of \[18F\]NOTA-ABY-030 in identifying indeterminate metastatic and/or primary lesions in head and neck squamous cell carcinoma (HNSCC), with a focus on sensitivity, specificity, and feasibility of the imaging protocol in a broader patient population.
Interventions
Given IV
Given Bolus Injection
Undergo PET/CT
Eligibility Criteria
You 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
- Phosphorus
You may not qualify 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eben Rosenthal, MD
Vanderbilt University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Barry and Amy Baker Professor and Department Chair
Study Record Dates
First Submitted
October 13, 2025
First Posted
October 15, 2025
Study Start
April 1, 2026
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
September 1, 2030
Last Updated
April 29, 2026
Record last verified: 2026-02