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Study of Pucotenlimab with Becotatug Vedotin versus Becotatug Vedotin alone for patients with locally advanced head and neck squamous cell carcinoma

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What is this trial about?

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

This study focuses on patients with locally advanced head and neck squamous cell carcinoma, a type of cancer that develops in the tissues of the head and neck region. The study tests two medications: MRG003, a drug that targets a specific protein called EGFR on cancer cells, and pucotenlimab, a medication that helps the immune system fight cancer cells. Both medications are given through intravenous injection, which means they are delivered directly into the bloodstream through a vein.

The purpose of this research is to determine how well patients respond to treatment when receiving MRG003 alone compared to receiving both MRG003 and pucotenlimab together. After receiving these study medications, all patients will proceed to receive chemoradiotherapy, which combines traditional cancer-fighting drugs with radiation treatment.

During the study, patients will receive the study medications over several weeks. MRG003 is given based on body weight, while pucotenlimab is given at a fixed dose. Doctors will monitor patients' responses to treatment and check for any side effects throughout the study period. The total treatment period may last up to several months, including the initial medication phase and the following chemoradiotherapy.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    You will undergo evaluation to confirm your eligibility for the trial, including head and neck imaging and laboratory tests

    Your hearing ability will be assessed to ensure it meets the required criteria

    Your general health status will be evaluated using the ECOG performance scale, which measures your ability to perform daily activities

  2. Step 2

    Treatment group assignment

    You will be randomly assigned to one of two treatment groups:

    Group 1: Treatment with both MRG003 and pucotenlimab

    Group 2: Treatment with MRG003 alone

  3. Step 3

    Induction treatment phase

    You will receive medication through intravenous infusion

    The treatment will be administered in cycles

    After the last cycle, you will wait 21-28 days before undergoing evaluation

  4. Step 4

    Treatment response evaluation

    Your response to the induction treatment will be evaluated using head and neck imaging

    The medical team will assess if the tumor has responded to the treatment

  5. Step 5

    Chemoradiotherapy phase

    You will receive cisplatin-based chemotherapy combined with radiation therapy

    The treatment schedule and total doses will be determined by your medical team

  6. Step 6

    Follow-up period

    Regular check-ups will monitor your health and treatment response

    Side effects will be tracked using standardized criteria (NCI-CTCAE)

    Follow-up will continue until one month after the end of adjuvant treatment

Who can join the trial?

16 criteria

  • Age between 18 and 75 years
  • Good physical condition with an ECOG performance status of 0 or 1 (able to carry out all normal activities with minimal restrictions)
  • Confirmed diagnosis of previously untreated advanced head and neck cancer that meets specific staging criteria
  • Tumor that can be measured using CT scan (detailed X-ray imaging) or MRI (magnetic resonance imaging)
  • Must be able to receive treatment with cisplatin (a type of chemotherapy medication)
  • No hearing loss or only mild hearing problems (grade 2 or less)
  • Must have acceptable blood test results within 14 days before starting the study, including:
    • Adequate white blood cell count
    • Adequate platelet count
    • Adequate hemoglobin levels
    • Normal liver function tests
    • Normal kidney function
    • No previous treatments for head and neck cancer, including:
      • No prior chemotherapy
      • No prior immunotherapy
      • No prior targeted therapy
      • No prior radiation therapy
      • No prior surgery in the head and neck area

Who cannot join the trial?

15 criteria

  • Previous treatment with EGFR antibody therapy (drugs targeting a specific protein involved in cell growth)
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • History of another cancer within the past 5 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Serious heart conditions, including:
    • Uncontrolled high blood pressure
    • Heart attack within past 6 months
    • Unstable heart disease
    • Active autoimmune disease (when body's immune system attacks healthy cells)
    • Active or chronic infections, including:
      • Hepatitis B
      • Hepatitis C
      • HIV
      • Tuberculosis
      • Pregnant or breastfeeding women
      • Known allergies to study medications or their components
      • Participation in another clinical trial within 30 days before starting this study
      • Any condition that, in the opinion of the study doctor, would make participation unsafe
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Investigated drugs

Pucotenlimab is a medication that belongs to a group called PD-1 inhibitors. It works by helping your immune system fight cancer cells. This medication is designed to boost your body's natural defenses against head and neck cancer. MRG003 is an antibody-drug conjugate (ADC) that specifically targets EGFR (Epidermal Growth Factor Receptor) on cancer cells. This medication is designed to deliver cancer-fighting substances directly to tumor cells while minimizing damage to healthy cells. Chemoradiotherapy is a combination treatment that includes both chemotherapy (cancer-fighting medications) and radiation therapy. This combined approach is used to treat cancer cells from multiple angles.

What is already known about the treatment

  • Pucotenlimab

    A monoclonal antibody that belongs to the class of PD-1 inhibitors, administered through intravenous infusion in clinical settings. This immunotherapy medication works by blocking the PD-1 receptor on T-cells, which enhances the immune system's ability to detect and fight cancer cells, particularly in head and neck squamous cell carcinoma. Currently being investigated in clinical trials, it represents a newer generation of immune checkpoint inhibitors designed to improve cancer treatment outcomes.

  • MRG003

    An antibody-drug conjugate (ADC) that specifically targets the epidermal growth factor receptor (EGFR), delivered via intravenous infusion. This targeted therapy combines an antibody that specifically binds to EGFR on cancer cells with a potent anti-cancer drug, allowing for precise delivery of the therapeutic agent to tumor cells while minimizing damage to healthy tissues. It is currently being evaluated in clinical trials for the treatment of locally advanced head and neck squamous cell carcinoma.

Investigated diseases

Head and Neck Squamous Cell Carcinoma (HNSCC) - A cancer that begins in the squamous cells that line the moist surfaces inside the head and neck regions, including the mouth, nose, and throat. The disease typically starts in the thin, flat cells of the epithelium and can spread to nearby tissues and lymph nodes. In locally advanced stages, the cancer has grown larger or spread to nearby tissues or lymph nodes, but has not spread to distant parts of the body. HNSCC commonly develops gradually and may cause symptoms such as persistent sore throat, difficulty swallowing, voice changes, or lumps in the neck area. The condition can affect various areas of the head and neck region, including the oral cavity, pharynx, larynx, and nasal cavity.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510558-18-00Protocol codeGORTEC 2024-03Estimated enrolment106 patientsSponsorGroupe Oncologie Radiotherapie Tete Cou

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).