Study Evaluating the Safety and Feasibility of Panitumumab-IRDye800 and [18F]NOTA-ABY-030 for Targeted Dual-Modality Imaging (TDMI) in Head and Neck Squamous Cell Carcinoma

Phase I Open-Label Study Evaluating the Safety and Feasibility of Panitumumab-IRDye800 and [18F]NOTA-ABY-030 for Targeted Dual-Modality Imaging (TDMI) in Head and Neck Squamous Cell Carcinoma

The goal of this clinical trial is to learn whether using two imaging agents-Panitumumab-IRDye800 (Pan800) and[18F]NOTA-ABY-030-is safe and feasible for helping surgeons identify tumors and cancer-containing lymph nodes during surgery in adults with head and neck squamous cell carcinoma (HNSCC) who are scheduled for tumor removal and neck dissection.

The main questions it aims to answer are:

• Is the combination of Pan800 and [18F]NOTA-ABY-030 safe and well tolerated in patients undergoing surgery for HNSCC?
• How accurately can Pan800 and [18F]NOTA-ABY-030 detect tumor tissue and cancer-positive lymph nodes when compared with final pathology results?

This is a single-arm, open-label study, so there is no comparison group.

Study Related Steps:

• Receive an intravenous infusion of Pan800 1-2 days before surgery.
• Receive an intravenous injection of[18F]NOTA-ABY-030 on the day of surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Head and Neck Cancer; Squamous Cell Carcinoma; Head and Neck Surgery; HNSCC,Larynx, Pharynx and Oral Cavity
• Intervention / Treatment: Drug: Panitumumab-IRDye800; Drug: [18F]NOTA-ABY-030

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Makenna Brown; Phone Number: 6154214370; Email: makenna.l.brown@vumc.org
• Study Contact Backup: Name: Nicole Jones; Email: nicole.l.jones@vumc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years.
2. Subjects diagnosed with any T stage or N stage squamous cell carcinoma and any subsite within the head and neck that are scheduled to undergo surgical resection and neck dissection. Subjects with recurrent disease or a new primary will be allowed.

3. Have acceptable hematologic status, kidney function, and liver function including the following clinical results:

   • Hemoglobin ≥ 9 gm/dL
   • White blood cell count > 3000/mm3
   • Platelet count ≥ 100,000/mm3
   • Serum creatinine ≤ 1.5 times upper reference range
   • Ability to understand and the willingness to sign a written informed consent document.

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. Evidence of QTcF prolongation on ECG within 30 days of pan800 administration (greater than 480 ms).
3. History of infusion reactions to monoclonal antibody therapies.
4. History of allergies to iodine.
5. Pregnant or breastfeeding.
6. Magnesium or phosphorus lower than the normal institutional values and the patient is symptomatic.
7. Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
8. Subjects with history or evidence of interstitial pneumonitis or pulmonary fibrosis.
9. Severe renal disease or anuria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5.0 mCi - [18F]NOTA-ABY-030 and 50 mg - pan800	Drug: Panitumumab-IRDye800; IV Infusion of 50 mg dose of Panitumumab-IRDye800 (Pan800) 1-2 days before surgery.; Drug: [18F]NOTA-ABY-030; Single intravenous bolus injection of approximately 5 mCi (±10%) in the operating room prior to tumor removal and neck dissection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Record and evaluate the number events considered clinically significant Grade ≥2 AEs that are considered possibly, probably, or definitely related to [¹⁸F]NOTA-ABY-030, pan800, or both agents.	Up to 30 Days

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2031

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 29, 2026
• First Posted (Actual): August 3, 2026

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 29, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: HNSCC; SCC; Oral Cavity; Fluorescent Guided Surgery
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Neoplasms, Squamous Cell; Otorhinolaryngologic Diseases; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Laryngeal Diseases
• Other Study ID Numbers: VICCHNP26039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We do not plan to share individual participant data from this phase 1 study due to its exploratory nature with a new drug. Sharing individual-level data at this stage could compromise participant confidentiality and may not yield meaningful insights given the preliminary scope of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No