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Study on the Safety of GEN1053 Alone and with an Immunomodulator for Patients with Malignant Solid Tumors

Fast replyInvestigationalNo placebo
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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 the effects of a new treatment called HexaBody-CD27 on people with malignant solid tumors. These are types of cancer that form in solid organs or tissues, such as the lungs, liver, or pancreas. The study will explore how safe and tolerable this treatment is when used alone and when combined with another type of medicine that helps the immune system fight cancer, known as an immunomodulator.

The purpose of the study is to evaluate the safety and initial effects of HexaBody-CD27 on these tumors. Participants will receive the treatment through an infusion, which means the medicine is given directly into the bloodstream through a vein. The study will start with a phase where different doses of the treatment are tested to find the most suitable one. After this, the study will expand to include more participants to further assess the treatment's safety and effects.

Throughout the study, researchers will monitor participants for any side effects and measure how the treatment affects the tumors. This will help determine if HexaBody-CD27 can be a potential option for treating malignant solid tumors. The study aims to provide valuable information about the treatment's safety and how it might help people with these types of cancer in the future.

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

    Joining the trial

    Upon joining the clinical trial, you will be introduced to the study team. They will provide you with detailed information about the trial, including its purpose and what to expect during your participation.

    You will be asked to sign an informed consent form, which confirms that you understand the trial and agree to participate.

  2. Step 2

    Initial assessments

    Before starting the treatment, you will undergo a series of assessments. These may include blood tests, imaging scans, and other evaluations to determine your current health status and ensure you meet the trial's eligibility criteria.

    These assessments help establish a baseline for your health, which will be used to monitor your progress throughout the trial.

  3. Step 3

    Treatment administration

    You will receive the study medication, HexaBody-CD27, which is a concentrate for solution for infusion. This means it will be administered directly into your bloodstream through an intravenous (IV) line.

    The dosage and frequency of administration will be determined by the study team based on the trial's protocol. You will be informed of the schedule and any specific instructions you need to follow.

  4. Step 4

    Ongoing monitoring

    Throughout the trial, you will have regular visits with the study team. These visits are important for monitoring your health and the effects of the treatment.

    You may undergo additional tests and assessments during these visits to track your response to the medication and identify any side effects.

  5. Step 5

    Completion of treatment

    Once you have completed the treatment phase of the trial, you will have a final set of assessments to evaluate your overall health and the impact of the treatment.

    The study team will discuss the results with you and provide guidance on any next steps or follow-up care that may be needed.

  6. Step 6

    Follow-up period

    After the treatment phase, there may be a follow-up period where the study team continues to monitor your health. This is to ensure your well-being and gather additional data on the long-term effects of the treatment.

    You will be informed of the schedule and any specific activities or assessments required during this period.

Who can join the trial?

18 criteria

  • Must be 18 years of age or older.
  • Must have a disease that can be measured according to specific medical guidelines (RECIST 1.1).
  • Must provide all available scans from before starting the study, especially if the last treatment did not work.
  • Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • Must have proper organ and bone marrow function, including:
    • Bone marrow function:
      • Absolute neutrophil count (ANC) of at least 1.5 x 109/L.
      • Hemoglobin level of at least 9.0 g/dL.
      • Platelet count of at least 150 x 109/L.
      • Liver function:
        • Total bilirubin within normal limits.
        • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels no more than 1.5 times the upper limit of normal.
        • Albumin level of at least 30 g/L.
        • Coagulation status:
          • Prothrombin time (PT)/International normalized ratio (INR) of no more than 1.5.
          • Activated partial thromboplastin time (aPTT) no more than 1.5 times the upper limit of normal.
          • Renal function:
            • Glomerular filtration rate (GFR) of at least 45 mL/min/1.73 m2, which measures kidney function.
            • For the initial part of the study (Monotherapy Dose Escalation and Combination therapy Dose Escalation):
              • Must have confirmed non-CNS (central nervous system) solid tumors that are metastatic (spread to other parts of the body) or advanced.
              • Must have tried standard treatments that did not work, or there are no standard treatments available that are likely to help, or the patient is not a candidate for standard treatments, or the patient has refused standard treatments.
              • Must agree to provide fresh biopsies, which are samples of tissue taken from the body for testing.
              • For the later part of the study (Expansion part):
                • Must have a confirmed diagnosis of recurrent, unresectable, or metastatic head and neck squamous cell carcinoma (HNSCC) or metastatic non-small cell lung cancer (NSCLC).
                • Must not have any further standard treatments available, or not be a candidate for standard treatments, or have refused standard treatments.

Who cannot join the trial?

10 criteria

  • Patients with any other active **cancer** besides the one being studied cannot participate.
  • Patients who have had a **heart attack** or other serious heart problems in the past 6 months are not eligible.
  • Patients with **uncontrolled high blood pressure** cannot join the study.
  • Patients with **severe liver or kidney disease** are excluded.
  • Patients who are **pregnant or breastfeeding** cannot participate.
  • Patients who have an **active infection** that requires treatment with antibiotics are not eligible.
  • Patients who have received another **experimental treatment** in the last 4 weeks cannot join the study.
  • Patients with a known **allergy** to the study drug or its ingredients are excluded.
  • Patients with **autoimmune diseases** that require treatment with drugs that suppress the immune system cannot participate.
  • Patients who have had a **major surgery** in the past 4 weeks are not eligible.
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Investigated drugs

GEN1053 is a new medication being tested to see if it is safe and effective for people with certain types of cancer. It is being studied both by itself and together with another type of treatment called an immunomodulator. The goal is to find out how much of the medication can be given safely and to learn about any side effects it might cause. This medication is part of a trial to help researchers understand if it can help treat cancer by itself or when used with other treatments.

An immunomodulator is a type of treatment that helps the body's immune system work better. In this trial, it is used in combination with GEN1053 to see if it can help the immune system fight cancer more effectively. The researchers want to find out if using an immunomodulator with GEN1053 can improve the treatment's ability to target and destroy cancer cells while also checking for any side effects that might occur when these treatments are used together.

What is already known about the treatment

GEN1053 – GEN1053 is administered as an injection, typically given directly into the bloodstream. It is currently being studied in clinical trials and is not yet widely available in medical practice. The main use of GEN1053 is to treat malignant solid tumors, which are a type of cancer. At the molecular level, GEN1053 works by interacting with specific proteins on cancer cells, helping the immune system to better recognize and attack these cells. It is classified as an investigational cancer therapy, focusing on enhancing the body's immune response to fight cancer.

Investigated diseases

Malignant Solid Tumors – Malignant solid tumors are abnormal masses of tissue that arise from the uncontrolled growth of cells in various organs or tissues. These tumors can occur in any part of the body, including the lungs, breast, prostate, and colon. As they grow, they can invade nearby tissues and organs, causing damage and disrupting normal function. Over time, malignant solid tumors may spread to other parts of the body through the bloodstream or lymphatic system, a process known as metastasis. The progression of these tumors can vary widely depending on the type of cancer, its location, and other factors. They often lead to the formation of new blood vessels to supply the growing tumor with nutrients, a process called angiogenesis.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2022-502419-12-00Protocol codeGCT1053-01Estimated enrolment170 patientsSponsorGenmab B.V.

sourced from the EU Clinical Trials Register and site verification

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