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Fluorescently Labeled Panitumumab for Head and Neck Cancer Surgery

This study is investigating Panitumumab-IRDye800 (Pan800) in people with head and neck squamous cell carcinoma (HNSCC). Panitumumab is an approved anti-cancer drug (Vectibix) that attaches to cancer cells. Pan800 is Panitumumab combined with an investigational dye (IRDye800) that helps doctors see human tissue better during surgery using a special camera. The main goal is to find the best dose of Panitumumab that concentrates in tumors. This could help surgeons remove cancer more completely and identify cancerous lymph nodes. You may be eligible if you are over 18, have HNSCC, and are planning to have surgery. The study is currently recruiting 60 participants.

Study design
This is an interventional study with a planned enrollment of 60 participants. The study aims to determine the maximum tumor concentrating dose of panitumumab.
What's involved
Study participation would last approximately 60 days from screening to follow-up visits. You would receive a dose of Panitumumab based on your weight and a standard dose of Panitumumab IRDye800.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at up to 21 days per patient.

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NCT06819228

Window Trial of Fluorescently Labeled Panitumumab (Panitumumab-IRDye800) in Head and Neck Cancer

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
Vanderbilt-Ingram Cancer Center
~70 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Panitumumab IRDye 800

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine maximum tumor concentrating dose (MTC) of panitumumab in HNSCC.
Measured over Up to 21 days per patient

Conditions

HNSCC
HNSCC,Larynx, Pharynx and Oral Cavity
SCC - Squamous Cell Carcinoma

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Head and Neck Squamous Cell CarcinomaSoluble Epidermal Growth Factor Receptor

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Eben L Rosenthal, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University/Ingram Cancer Center

Who to contact

Makenna Brown, Clinical Research Coordinator
[email protected]
615-421-4370
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Eligibility criteria

Inclusion

Willing to review and sign written informed consent.
Male or female patients age \> 18 years.
Tissue confirmation of head and neck squamous cell carcinoma.
Patients for whom a potentially curative resection is planned as standard of care.
ECOG performance status of 0 or 1
Adequate hematologic and end-organ function appropriate for surgery as determined by routine preoperative evaluation. If liver function, renal function and hematologic laboratory test results are acceptable for elective surgery, the patient is considered eligible for the study. Laboratory results that will need to be obtained within 30 days prior to initiation of study treatment: Magnesium, Phosphorus, serum pregnancy test (for females of childbearing age).
For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods as defined below:
age \>55 years old
age \<55 years or less and
at least 12 months since last menstrual period,
at least 6 months since last menstrual period and FSH \> 40 IU
Women of childbearing potential must have a negative pregnancy test result within 14 days prior to initiation of study treatment.
Women must remain abstinent or use effective contraceptive methods during the treatment period and for 5 months after the final dose of panitumumab.
Men must agree to remain abstinent or use a condom during the treatment period and for 5 months after the final dose of panitumumab/pan800 to avoid exposing the embryo. Men must agree to refrain from donating sperm during this same period.

Exclusion

Patients not eligible for standard of care surgical resection
Patients with a history of infusion reactions or allergic reactions to panitumumab.
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
Active tuberculosis. Patients do NOT have to be screened for tuberculosis for this trial.
Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.
History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. The following drugs are known to interact with panitumumab and therefore any patients taking these medications within 30 days will be ineligible for the trial.
Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment.
Magnesium or phosphorus lower than normal institutional values, patient is symptomatic, and the values are unable to be corrected through standard repletion strategies.
Evidence of QTcF prolongation on pretreatment ECG.

What this trial measures

  • Determine maximum tumor concentrating dose (MTC) of panitumumab in HNSCC.Up to 21 days per patient

    Drug concentration in the tumor will be measured (drug ng/tissue mg) utilizing special imaging devices (such as the Tecan Spark, LI-COR Pearl Trilogy, LI-COR Elvis, and LI-COR Odyssey). These devices will only be used once the tissue is removed per Standard of Care during surgery and then comparing cancerous tissue to healthy tissue. The maximum tumor concentrating dose will be defined as the lower dose of drug after two consecutive doses demonstrate the same maximum concentration of intra-tumoral drug. The investigators will further evaluate if multiple doses are required to fully concentrate HNSCC in Cohort 2. The MTC dose with 1 vs 2 infusions preoperatively will be compared.