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

NCT07741643 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: VICCHNP26039
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HNSCC,Larynx, Pharynx and Oral Cavity; Squamous Cell Carcinoma; Head and Neck Cancer; Head and Neck Surgery

Keywords

SCC; HNSCC; Oral Cavity; Fluorescent Guided Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

5.0 mCi - [18F]NOTA-ABY-030 and 50 mg - pan800

EXPERIMENTAL

Drug: Panitumumab-IRDye800; Drug: [18F]NOTA-ABY-030

Interventions

Panitumumab-IRDye800 DRUG

IV Infusion of 50 mg dose of Panitumumab-IRDye800 (Pan800) 1-2 days before surgery.

5.0 mCi - [18F]NOTA-ABY-030 and 50 mg - pan800

[18F]NOTA-ABY-030 DRUG

Single intravenous bolus injection of approximately 5 mCi (±10%) in the operating room prior to tumor removal and neck dissection.

5.0 mCi - [18F]NOTA-ABY-030 and 50 mg - pan800

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• 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.
• 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.

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

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Laryngeal Diseases; Carcinoma, Squamous Cell; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neoplasms, Squamous Cell

Central Study Contacts

Makenna Brown

CONTACT

6154214370; makenna.l.brown@vumc.org

Nicole Jones

CONTACT

nicole.l.jones@vumc.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• 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: July 6, 2026
• First Posted: August 3, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: August 3, 2026

Record last verified: 2026-07