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Study of bemarituzumab treatment for patients with solid tumors that have high levels of FGFR2b protein

Verified siteInvestigationalNo placebo
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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 various types of solid tumors that have a specific characteristic called FGFR2b overexpression. The types of cancer being studied include head and neck squamous cell carcinoma, triple-negative breast cancer, intrahepatic cholangiocarcinoma, lung adenocarcinoma, ovarian epithelial carcinoma, endometrial adenocarcinoma, and cervical carcinoma. The treatment being tested is a medicine called bemarituzumab (also known as AMG 552), which is given through an intravenous infusion directly into the bloodstream.

The purpose of this research is to test how safe bemarituzumab is and how well it works in treating different types of solid tumors. The study is divided into two parts. In the first part, doctors will closely monitor how patients respond to the medication and any side effects that may occur. In the second part, they will evaluate how effective the medication is at fighting the cancer.

During the study, patients will receive bemarituzumab through regular infusions. The doctors will track the progress of the treatment using different medical tests and imaging scans such as computed tomography (CT) or magnetic resonance imaging (MRI). They will monitor how the tumors respond to the treatment and keep track of any changes in the patient's health throughout the study period.

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

    Initial eligibility verification

    Your cancer type must be confirmed through tissue examination and meet specific requirements for prior treatments

    Your tumor must show high levels of FGFR2b protein through a special laboratory test

    Your cancer must be measurable using standard imaging techniques

    Blood tests will be performed to verify adequate organ function

  2. Step 2

    Treatment phase initiation

    Bemarituzumab will be administered through an intravenous infusion

    Regular monitoring of vital signs during and after infusion

    Vision tests will be conducted to monitor eye health

    Blood samples will be collected to measure drug levels in your body

  3. Step 3

    Ongoing monitoring

    Regular imaging scans (CT or MRI) to measure tumor response

    Blood tests to monitor organ function

    Assessment of any side effects or changes in health status

    Vision checks will continue throughout treatment

  4. Step 4

    Response evaluation

    Your response to treatment will be assessed through regular imaging scans

    The medical team will evaluate if the tumor has shrunk (partial response) or disappeared (complete response)

    The duration of any positive response will be tracked

    Your overall health status will be monitored throughout the study period

  5. Step 5

    Long-term follow-up

    Continued monitoring of your health status

    Regular assessment of cancer progression

    Documentation of long-term treatment outcomes

    The study is expected to continue until September 2026

Who can join the trial?

17 criteria

  • Must be an adult (18 years or older)
  • Must have a confirmed diagnosis of one of these cancers that has returned or not responded to previous treatment:
    • Head and neck cancer (after at least 1 previous treatment)
    • Triple-negative breast cancer (after at least 2 previous treatments)
    • Bile duct cancer (after at least 1 previous treatment)
    • Lung cancer (after chemotherapy, immunotherapy, and targeted therapy if applicable)
    • Ovarian, fallopian tube, or peritoneal cancer that has progressed within 6 months of platinum treatment
    • Endometrial cancer (after at least 1 previous treatment)
    • Cervical cancer (after at least 1 previous treatment)
    • Other solid tumors (after at least 1 previous treatment)
    • Must have tumors that show high levels of a protein called FGFR2b through special testing
    • Must have tumors that can be measured using specific criteria (RECIST)
    • Must have adequate blood cell counts:
      • White blood cells (neutrophils) at least 1.5 x 10^9/L
      • Platelets at least 100 x 10^9/L
      • Hemoglobin at least 9 g/dL
      • Must have adequate liver function
      • Must have adequate kidney function
      • Must have normal blood clotting function (unless on blood thinners with stable dosing for at least 6 weeks)

Who cannot join the trial?

14 criteria

  • History of severe allergic reactions or anaphylaxis (serious, life-threatening allergic reactions)
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Significant heart problems including:
    • Unstable heart disease
    • Heart attack within last 6 months
    • Uncontrolled high blood pressure
    • Active, uncontrolled infections
    • Other cancer diagnosis within the past 3 years (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
    • Pregnant or breastfeeding women
    • Major surgery within 4 weeks before starting the study treatment
    • Participation in another clinical trial within 4 weeks before starting this study
    • Serious medical conditions that could interfere with study participation
    • Known positive test for HIV, active hepatitis B, or active hepatitis C
    • History of organ transplantation
    • Current use of medications that could interact with the study drug
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Investigated drugs

Bemarituzumab is a targeted therapy medication that works by binding to a specific protein called FGFR2b found on the surface of certain cancer cells. This medication is being studied as a standalone treatment for patients who have solid tumors that produce too much FGFR2b protein. It is designed to help fight cancer by targeting and blocking the activity of this protein, which may help stop cancer cells from growing and spreading.

What is already known about the treatment

Bemarituzumab - A monoclonal antibody administered through intravenous infusion, specifically designed to target FGFR2b (Fibroblast Growth Factor Receptor 2b) overexpression in solid tumors. This investigational drug is currently being studied in clinical trials for its potential anti-cancer properties, particularly in treating various types of solid tumors where FGFR2b is overexpressed. The medication works by selectively binding to FGFR2b on cancer cells, potentially blocking growth signals and inhibiting tumor progression, and belongs to the class of targeted cancer therapies known as monoclonal antibodies. Based on current medical literature, bemarituzumab represents a novel approach in precision oncology, with ongoing research focusing on its safety profile and therapeutic efficacy.

Investigated diseases

Solid tumors - A type of cancer that develops as a solid mass of abnormal cells in various organs or tissues of the body. These growths form when cells multiply uncontrollably and cluster together, creating lumps or masses that can occur in many different parts of the body such as the breast, lung, colon, or other organs. Solid tumors can be either benign (non-cancerous) or malignant (cancerous), with malignant tumors having the ability to invade nearby tissues. The growth of solid tumors typically progresses gradually as cells continue to multiply and the mass increases in size. These tumors can often be detected through physical examination or imaging when they reach a certain size.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-505455-44-00Protocol code20210104Estimated enrolment442 patientsSponsorAmgen Inc.

sourced from the EU Clinical Trials Register and site verification

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