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Study on the Effects of Ficlatuzumab and Cetuximab for Adults with Recurrent or Metastatic HPV-Negative Head and Neck Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as Head and Neck Squamous Cell Carcinoma (HNSCC). This cancer affects the cells lining the mouth, nose, and throat. The study is specifically looking at cases where the cancer is HPV-negative, meaning it is not associated with the human papillomavirus, and has either returned after treatment or spread to other parts of the body.

The trial will test the effects of two medications used together: Ficlatuzumab and Cetuximab. Ficlatuzumab, also known by its code name AV-299, is a type of protein treatment given through an intravenous infusion, which means it is administered directly into the bloodstream. Cetuximab is another protein-based treatment, also given by intravenous infusion, and is already used in treating certain types of cancer. The study will compare the combination of these two drugs against a placebo combined with Cetuximab to see if the combination improves overall survival in patients.

Participants in the study will receive either the combination of Ficlatuzumab and Cetuximab or a placebo with Cetuximab. The study will monitor the participants over a period to assess the effects of the treatment on their cancer. The main goal is to determine if the combination of these two drugs can help patients live longer. The study will also look at other factors, such as how long the cancer stays under control and any side effects experienced by the participants.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be randomly assigned to one of two groups. One group will receive the combination of ficlatuzumab and cetuximab, while the other group will receive a placebo with cetuximab.

    The study is designed to be double-blind, meaning neither the participant nor the study team will know which group the participant is in.

  2. Step 2

    Treatment administration

    Participants will receive ficlatuzumab or placebo through an intravenous infusion. The dosage and frequency will be determined by the study protocol.

    In addition, all participants will receive cetuximab as an intravenous infusion. The dosage is 5 mg/mL, and the frequency will be specified by the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants will undergo regular monitoring to assess their health and the effects of the treatment.

    This includes blood tests to measure the concentration of ficlatuzumab and cetuximab, as well as to check for any adverse effects or laboratory abnormalities.

  4. Step 4

    Evaluation of treatment response

    The study will evaluate the overall survival of participants, which is the time from the start of the study to the date of death from any cause.

    Secondary evaluations include progression-free survival, objective response rate, disease control rate, and duration of response.

  5. Step 5

    Completion of the study

    The study is expected to continue until April 2027. Participants will be followed up until the study's completion to gather comprehensive data on the treatment's effectiveness and safety.

Who can join the trial?

19 criteria

  • Must be a male or female who is 18 years of age or older.
  • Must have a confirmed diagnosis of **recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)**. This means the cancer has returned or spread to other parts of the body.
  • If the cancer is in the oropharynx (part of the throat), it must be **p16 negative** and **HPV-negative**. HPV is a virus that can affect the throat, and p16 is a protein related to HPV.
  • Must have at least one measurable tumor that can be seen on a CT or MRI scan. This tumor should not have been treated with radiation before, unless it has clearly grown since then.
  • Must have previously tried treatment with **anti-PD-1/PD-L1 ICI** and **platinum-based chemotherapy**. These are types of cancer treatments. The treatment must have failed either because the cancer progressed or the patient could not tolerate the treatment.
  • The tumor must be considered **inoperable and incurable** by the doctor. This means surgery is not an option, and the cancer cannot be cured.
  • Must have a **performance status** of 0 or 1 according to the **Eastern Cooperative Oncology Group (ECOG)** scale, which measures how well a patient can perform daily activities. The patient should have a life expectancy of at least 12 weeks.
  • Must have certain **laboratory test results** within specific ranges, including:
    • **Serum creatinine clearance** greater than 30 mL/min, which measures kidney function.
    • **Total bilirubin** less than or equal to 1.5 times the upper limit of normal, which measures liver function.
    • **AST and ALT** less than or equal to 2.5 times the upper limit of normal, or less than or equal to 5 times if there are liver metastases. These are liver enzymes.
    • **aPTT and PT/INR** less than or equal to 1.5 times the upper limit of normal, unless on blood-thinning medication. These tests measure blood clotting.
    • **Absolute neutrophil count (ANC)** of at least 1200 cells/µL, which measures a type of white blood cell.
    • **Hemoglobin (Hgb)** of at least 9 g/dL, which measures red blood cells. Blood transfusions are allowed to reach this level.
    • **Platelet count** of at least 75,000/µL, which measures cells that help with blood clotting.
    • Women who can have children must have a negative pregnancy test within 30 days before starting the study.
    • Both women who can have children and men with partners who can have children must agree to use effective birth control during the study and for at least 5 months after the last treatment.
    • Must be able to provide written consent to participate and follow the study requirements.
    • Patients with feeding tubes can participate in the study.
    • Must provide a sample of the tumor tissue for analysis within 60 days of starting the study. If a sample is not available, the reason must be documented and discussed with the study team.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than Head and Neck Squamous Cell Carcinoma (HNSCC) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to give informed consent or understand the study requirements cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have allergies or reactions to the study medications cannot participate.
  • Patients who are taking certain medications that might interfere with the study cannot participate.
  • Patients who have a history of substance abuse or alcohol dependency may not be eligible.
  • Patients who have had a recent major surgery or are planning to have surgery during the study period cannot participate.
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Investigated drugs

  • Ficlatuzumab

    is an investigational medication being studied for its potential to treat head and neck squamous cell carcinoma. It is being tested to see if it can help improve survival in patients whose cancer has returned or spread to other parts of the body. Ficlatuzumab works by targeting specific pathways in cancer cells, potentially slowing down or stopping their growth.

  • Cetuximab

    is a medication used to treat certain types of cancer, including head and neck cancer. It works by blocking a protein that cancer cells need to grow and divide. In this study, cetuximab is used in combination with ficlatuzumab to see if the two medications together can be more effective than cetuximab alone in treating recurrent or metastatic head and neck cancer.

What is already known about the treatment

  • Ficlatuzumab

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating head and neck squamous cell carcinoma (HNSCC). It is not yet widely used in standard medical practice, as it is still under investigation. Ficlatuzumab is primarily indicated for recurrent or metastatic HPV-negative HNSCC. It works by targeting and inhibiting the activity of a specific protein involved in tumor growth and survival, thereby potentially slowing down or stopping cancer progression. Ficlatuzumab is classified as a monoclonal antibody.

  • Cetuximab

    This medication is also administered intravenously and is an established treatment in oncology, particularly for certain types of head and neck cancers and colorectal cancer. In the context of the clinical trial, it is used in combination with ficlatuzumab to treat recurrent or metastatic HPV-negative head and neck squamous cell carcinoma. Cetuximab works by binding to the epidermal growth factor receptor (EGFR) on the surface of cancer cells, blocking signals that promote tumor growth. It is classified as an epidermal growth factor receptor (EGFR) inhibitor.

Investigated diseases

Head and Neck Squamous Cell Carcinoma (HNSCC) – This is a type of cancer that begins in the squamous cells lining the moist surfaces inside the head and neck. It can affect areas such as the mouth, throat, and nose. The disease often starts as a small, localized tumor and can progress to involve nearby tissues and lymph nodes. As it advances, it may spread to other parts of the body, a process known as metastasis. Symptoms can include a persistent sore throat, difficulty swallowing, and changes in voice. The progression of the disease can vary, with some cases remaining localized while others spread more aggressively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505606-42-00Protocol codeAV-299-23-301Estimated enrolment410 patientsSponsorAveo Pharmaceuticals Inc.

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