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

NCT06819228 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: VICCHNP24602
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study is exploring the use of Panitumumab in Head and Neck Cancer. Panitumumab is an approved drug named Vectibix and is used as an anti-cancer agent in other cancers such as colorectal cancer. It works by attaching to the cancer cell in a unique way that allows the drug to get into the cancer tissue. In addition to the Panitumumab, participants will also receive a Panitumumab-IRDye800 (Pan800) or a fluorescently labeled Panitumumab infusion. IRDye800 is an investigational dye that, when tested in the lab, helps various characteristics of human tissue show up better when using a special camera during surgery. Panitumumab-IRDye800 is a combination of the drug and the dye that attaches to cancer cells and appears to make them visible to the doctor when he or she uses the special camera during surgery. The goal of this study is to use a novel and possibly safer approach to identify an optimal dose for panitumumab to treat cancer patients by using a new light-based therapy. In this study, different drug levels will be analyzed using this approach to understand how much drug reaches the tumor at different administered doses, which may help us provide safer and/or more effective therapies in the future. The goal is to identify the correct amount or dose of a drug that is needed for effective cancer therapies. Often, clinical studies look at how much of the drug can be tolerated before patients become sick, rather than how much of the drug is required to be effective. IRDye800 is an investigational dye that, when tested in the lab, helps various characteristics of human tissue show up better when using a special camera during surgery. Panitumumab-IRDye800 is a combination of the drug and the dye that attaches to cancer cells and appears to make them visible to the doctor when he or she uses the special camera during surgery. This will help the surgeon with clinical margins during surgery and will may have a clearer way to differentiate between cancer and healthy tissue.

Conditions

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

Keywords

Pan800; Panitumumab; Fluorescent guided surgery; oral cancer; mouth cancer; tongue cancer; gum cancer; SCC; head and neck cancer; pharynx; HNSCC; larynx

Outcome Measures

Primary Outcomes (1)

• Determine maximum tumor concentrating dose (MTC) of panitumumab in HNSCC.

  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.

  Up to 21 days per patient

Secondary Outcomes (1)

• Determine the efficacy of panitumumabIRDye800 to identify cancer compared to surrounding normal tissue

  Up to 30 days per patient

Study Arms (2)

Cohort 1a - Cohort 1c

EXPERIMENTAL

These cohorts will receive one dose each of Pan800 (50 mg) and Panitumumab at a range of doses (varying of specific cohort).

Drug: Panitumumab IRDye 800

Cohort 2a - Cohort 2c

EXPERIMENTAL

These cohorts will receive one dose of Pan800 and and two doses of Panitumumab at a range of doses (varying of specific cohort).

Drug: Panitumumab IRDye 800

Interventions

Panitumumab IRDye 800 DRUG

Study participation would last approximately 60 days from screening to follow-up visits. Participants dose of Panitumumab would be based on weight and Panitumumab IRDye800 is dosed the same for all participants.

Cohort 1a - Cohort 1c; Cohort 2a - Cohort 2c

Eligibility Criteria

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

You may qualify if:

• 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:
• A woman is considered to be of childbearing potential if she is post-menarchal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of the uterus and/or both ovaries and/or both fallopian tubes). Post-menarchal is defined as either:
• 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.

You may not qualify if:

• 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.
• History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• 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 QT prolongation on pretreatment ECG.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

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

Study Officials

• Eben L Rosenthal, MD

  Vanderbilt University/Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Jones, Clinical Research Coordinator

CONTACT

615-936-2807; nicole.l.jones@vumc.org

Carleigh Burns

CONTACT

615-669-7207; carleigh.burns@vumc.org

Study Design

• Study Type: interventional
• Phase: early 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 Chair

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 11, 2025
• Study Start: April 17, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)