A Phase 1 interventional study of Panitumumab IRDye 800 in HNSCC, HNSCC,Larynx, Pharynx and Oral Cavity and SCC - Squamous Cell Carcinoma, sponsored by Vanderbilt-Ingram Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Vanderbilt-Ingram Cancer Center · Phase 1, Interventional, and Diagnostic
Among 10 studies testing panitumumab in Squamous Cell Carcinoma of Head and Neck — 4 open to participants now, 4 under way, none of them phase 3. Panitumumab · Squamous Cell Carcinoma of Head and Neck.
Among the 10 studies testing panitumumab in Squamous Cell Carcinoma of Head and Neck, this one is the 2nd largest by planned enrollment, is the only one that started in 2025, is one of 6 in phase 1, and was the 9th registered.
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's planned enrollment of 70 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →4 of the 10 studies testing panitumumab in Squamous Cell Carcinoma of Head and Neck are open now, in 1 country. Each count lists the studies.
Panitumumab: first FDA approval 2006 (VECTIBIX), first EMA approval 2007. What it is approved for, and how studies give it, is on its page →
Of the 434 Squamous Cell Carcinoma of Head and Neck studies recruiting now, 310 (71%) set no upper age limit and 87 (20%) stop at 75 or younger; 5 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2025.
Median enrollment 32 across the 10 interventional studies. Of the 5 that completed or were terminated, 4 (80%) have results posted.
1 of 10 have an industry lead sponsor. The 7 most frequent:
Vanderbilt-Ingram Cancer Center is the lead sponsor of 223 studies on the registry; 33 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.
24 studies in Squamous Cell Carcinoma of Head and Neck by Vanderbilt-Ingram Cancer Center: 9 open now, 9 under way, none of them phase 3. Of 15 finished, 4 (27%) have results posted.
Among the 24 studies in Squamous Cell Carcinoma of Head and Neck by Vanderbilt-Ingram Cancer Center, this one has the largest planned enrollment of the 13 interventional ones, is one of 2 that started in 2025, is one of 8 in phase 1, and was the 19th registered.
Vanderbilt-Ingram Cancer Center’s Squamous Cell Carcinoma of Head and Neck studies by the year they started, since 2002.
None of the studies under way reaches primary completion within a year.
Among the 10 studies testing panitumumab in Squamous Cell Carcinoma of Head and Neck, from their registry updates:
Among Vanderbilt-Ingram Cancer Center’s 24 in Squamous Cell Carcinoma of Head and Neck:
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.
The primary objective of this study is to understand biologic dosing of panitumumab which would contribute to the field by establishing new methodology for dose selection with the aim of reducing toxicity in cancer patients. For the individual patient in this trial, panitumumab itself is unlikely to demonstrate anti-tumor efficacy. However, previous studies have shown some benefit when using panitumumab-IRDye800 (pan800) as an imaging agent intraoperatively. The investigators hope to improve patient outcomes by gathering clinical data to support pan800 as a tool for reducing positive surgical margins and to identify malignant lymph nodes during surgical resection.
The drug being used in this study, panitumumab, is approved by the US FDA for treatment of certain types of advanced colorectal cancer at a dosage of 6 mg/kg given every 14 days. Many of the reported adverse events are associated with repeat administration of panitumumab, rather than 1-2 doses being administered in this study. However, the investigators do anticipate some adverse events at therapeutic dosing (anticipated grade 1-2). The most common side effects patients have experienced when receiving panitumumab primarily include skin reactions (including acne like rash, dry or itchy skin, cracking of skin around the participants nail beds, skin infections, and dry eyes), fatigue, nausea, and diarrhea.
Currently, there is no standardized method to identify the optimal biologic dose (OBD) for oncology therapies. Traditionally, dosing has been based on toxicity levels, specifically the maximally tolerated dose (MTD), rather than actual therapeutic effectiveness. In early-stage oncology trials, MTD often guides dose selection, with plasma drug concentrations serving as a rough measure for dose optimization. However, this plasma provides limited insight into how much of the drug actually reaches the tumor or binds to the intended target.
This study proposes a novel approach to finding OBD by measuring tumor drug concentration in head and neck cancer patients using an optically labeled antibody therapy. The investigators hypothesize that if a drug reaches a maximum concentration at a lower dose that previously thought, there may be no utility in increasing systemic dosing and risk unnecessary toxicity as well as financial burden.
Our group has previously published data using a fluorescent labeled therapeutic antibody (panitumumab-IRDye800) to show heterogenous distribution of antibody within a patient tumor in head and neck cancer. These studies used a single standard dose of panitumumab-IRDye800 which was shown to localize to malignant tumor tissue with minimal adverse events. In this proposed clinical trial, investigators will leverage this previously used fluorescent drug to investigate tumor concentration at multiple dose points up to and including the current FDA approved therapeutic dose to investigate our primary objective. Investigators will similarly use intraoperative fluorescence to assess the ability of the labeled antibody to distinguish malignant vs benign tissue at a range of doses. This intraoperative use has the potential to help optimize surgical margins and identification of malignant lymph nodes in addition to our primary objective of dose selection.
The main aim of this study is to investigate tumor concentration of fluorescently-labeled panitumumab at multiple doses up to the current FDA-approved therapeutic dose of panitumumab. This will allow us to identify if tumor saturation with this agent occurs below the currently approved dose. For other molecularly-targeted agents, there is evidence that lower doses can provide similar therapeutic benefit to approved doses. For panitumumab, over 30% of patients receiving this agent receive dose reductions due to adverse effects, resulting in a significant proportion of patients receiving a dose that is below the approved level. However, it is unclear if patients receiving this reduced dose achieve tumor saturation and similar therapeutic benefit. In this study, researchers will investigate if tumor saturation plateaus at a lower dose - an objective in line with dose optimization guidelines from the FDA. Our group has previously published data using fluorescently-labeled panitumumab to show heterogenous distribution of antibody within a patient tumor in head and neck cancer. Data from our previous and current work have allowed us to elucidate the relationship between fluorescence and intratumoral antibody concentration. An additional aim of this study is to provide further data on the efficacy of fluorescently-labelled panitumumab in identifying cancer relative to surrounding normal tissue. Improved tumor localization of the fluorescent agent could facilitate improved margin resections in the operating room.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For women of : Agreement to remain abstinent (refrain from heterosexual intercourse) or use methods as defined below:
at least 6 months since last menstrual period and FSH > 40 IU
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
These cohorts will receive the estimated optimal dose based on results from the Cohort 1.
Drug: Panitumumab IRDye 800
Drug pages: Panitumumab · IRDye800
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.
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.
Time frame: Up to 21 days per patient
Determine the maximal pharmacodynamic dose (MPD) of pmab and its correlation to MTCD.
Panitumumab-IRDye800 fluorescence and tissue analyses will be used to investigate whether the dose that achieves maximal tumor drug concentration also results in maximal suppression of the EGFR signaling pathway. Following surgical resection, tumor specimens will undergo spatial transcriptomic, proteomic, and immunohistochemical analyses to evaluate EGFR pathway inhibition and tumor cell growth arrest at different dose levels. Investigators have extensive experience using panitumumab-IRDye800 in clinical studies, and these tissue-based assessments are not expected to add additional risk to participants beyond standard specimen collection. Results will be used to correlate tissue drug concentration with molecular suppression of EGFR signaling, helping to identify the optimal biologic dose that achieves target saturation and therapeutic effect without requiring higher drug exposures.
Time frame: Up to 30 days per patient
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — This is a Pilot study at a single site in the U.S. The investigators do not plan to share IPD with other researchers at this time.
Started Apr 2025 (actual). Primary completion is estimated for Mar 2028, 35 months after the start.
Of 113 non-industry phase 1 interventional studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 61. This study's planned 35 months is below that.
Counting every sponsor, half of 267 studies reached it within 49 months; a quarter within 33 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Panitumumab · IRDye800
Squamous Cell Carcinoma of Head and Neck →
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