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Study on the Safety and Effects of GEN1055 Alone and with Pembrolizumab for Patients with Malignant Solid Tumors

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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 GEN1055 on people with malignant solid tumors, which are a type of cancer that forms in solid organs or tissues. The study will explore how safe and effective GEN1055 is when used alone and in combination with another medication called pembrolizumab. GEN1055 is also known by the code name HexaBody-OX40. The trial will also involve other medications such as paclitaxel, carboplatin, cisplatin, pemetrexed disodium, gemcitabine, and paclitaxel albumin-bound, which are commonly used in chemotherapy treatments.

The purpose of the study is to evaluate the safety and preliminary effectiveness of GEN1055 in treating these tumors. Participants will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will start with a phase where the dose of GEN1055 is gradually increased to find the most suitable dose. After this, the study will expand to include more participants to further assess the treatment's effects.

Throughout the trial, researchers will monitor participants for any side effects and measure how the tumors respond to the treatment. The study aims to gather important information that could lead to new treatment options for people with malignant solid tumors. Participants may receive either the new treatment, a combination of treatments, or a placebo. The trial is expected to continue for several years to ensure comprehensive results are obtained.

The research process

The trial runs in 7 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 trial, the patient will be informed about the purpose and procedures of the study. Consent is required to participate, and additional consent may be needed for genomic biomarker analysis.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to ensure eligibility. This includes laboratory tests and providing a biopsy sample if possible. The patient's health status will be evaluated using the ECOG performance status score.

  3. Step 3

    Dose escalation phase

    The trial begins with a dose escalation phase to evaluate the safety of GEN1055 as a single treatment and in combination with pembrolizumab. The goal is to determine the appropriate dose for further study.

  4. Step 4

    Treatment administration

    The patient will receive GEN1055 through an intravenous infusion. If part of the combination therapy group, pembrolizumab will also be administered. The frequency and duration of administration will be determined by the trial protocol.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, the patient will be monitored for any adverse effects and the effectiveness of the treatment. Regular follow-up visits will be scheduled to assess the patient's response to the therapy.

  6. Step 6

    Expansion phase

    In the expansion phase, the antitumor activity of GEN1055 will be assessed. This phase aims to gather more data on the treatment's effectiveness and safety.

  7. Step 7

    Completion of trial

    The trial is expected to conclude by May 2028. Upon completion, the patient will undergo a final assessment to evaluate the overall impact of the treatment.

Who can join the trial?

15 criteria

  • Must sign an informed consent form (ICF) to show understanding of the trial's purpose and procedures and willingness to participate. If required, sign a separate ICF for providing samples for genetic analysis.
  • For the dose escalation part: Must have progressed on standard care (SoC) therapy, which includes treatments like platinum-based chemotherapy and anti-PD-1/PD-L1 therapies, if suitable for the tumor type. Alternatively, there should be no available standard therapy likely to help, and the trial treatment might be beneficial according to the investigator.
  • Must be willing and able to follow the rules and restrictions of the trial.
  • Must have acceptable laboratory test results before starting the trial treatment, including:
    • GFR (Glomerular Filtration Rate): At least 45 mL/min/1.73 m², which measures kidney function.
    • ALT (Alanine Aminotransferase) and AST (Aspartate Aminotransferase): No more than 3 times the upper limit of normal (ULN), which are liver enzymes.
    • Total Bilirubin: No more than 1.5 times ULN, a substance made by the liver.
    • Hemoglobin: At least 9 g/dL, which is a protein in red blood cells.
    • Absolute Neutrophil Count: More than 1.5 x 10⁹/L, which measures a type of white blood cell.
    • Platelet Count: More than 100 x 10⁹/L, which measures cells that help with blood clotting.
    • Must be at least 18 years old or the legal age of consent in the trial location.
    • Must have a measurable disease according to specific criteria (RECIST v1.1).
    • Must provide all scans done before the trial since the last treatment failure, if available.
    • Must have an ECOG Performance Status score of 0 to 1, which assesses daily living abilities.
    • Must provide a biopsy sample, which is a small tissue sample, unless it's not medically possible and approved by the sponsor. If a new biopsy can't be provided, a recent one from the last treatment failure may be used.
    • For the dose escalation part: Must have confirmed non-CNS (central nervous system) primary solid tumors and have metastatic or advanced disease.

Who cannot join the trial?

4 criteria

  • Patients with certain types of cancer called malignant solid tumors cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who do not meet other specific health criteria set by the study cannot participate.
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Investigated drugs

  • GEN1055

    is an investigational medication being studied for its potential to treat malignant solid tumors. In this clinical trial, researchers are exploring its safety and how well it works when used alone (monotherapy) and in combination with another medication. The goal is to find the right dose that can be used in future studies and to see if it can help shrink tumors or stop them from growing.

  • Pembrolizumab

    is a medication that is already used to treat certain types of cancer. It works by helping the immune system recognize and attack cancer cells. In this trial, pembrolizumab is being used in combination with GEN1055 to see if the two medications together can be more effective in treating malignant solid tumors than GEN1055 alone.

What is already known about the treatment

GEN1055 – GEN1055 is an investigational medication currently being studied in clinical trials for its potential use in treating malignant solid tumors. It is administered as an injection, either alone or in combination with another drug called pembrolizumab. The main goal of the ongoing trial is to evaluate the safety and preliminary effectiveness of GEN1055, as well as to determine appropriate dosing levels. GEN1055 is believed to work by targeting specific molecules involved in tumor growth, helping to inhibit their progression. It falls under the pharmacological classification of targeted cancer therapies, which aim to interfere with cancer cell growth at the molecular level.

Investigated diseases

Malignant Solid Tumors – These are abnormal masses of tissue that arise from cells that grow uncontrollably and can invade nearby tissues. They can occur in various parts of the body, such as the lungs, breast, prostate, or colon. As they progress, these tumors can spread to other parts of the body through the bloodstream or lymphatic system, a process known as metastasis. The growth and spread of malignant solid tumors can disrupt normal bodily functions and lead to various symptoms depending on their location. They are often characterized by their ability to grow rapidly and resist normal cell death processes. The progression of these tumors can vary widely depending on the type and location of the tumor.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-507049-28-00Protocol codeGCT1055-01Estimated enrolment225 patientsSponsorGenmab A/S

sourced from the EU Clinical Trials Register and site verification

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