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Study of ABTL0812 with Irinotecan and Temozolomide for Children with Relapsed or Refractory Neuroblastoma and Other 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 relapsed/refractory neuroblastoma and other solid tumors in children. Neuroblastoma is a type of cancer that forms in certain types of nerve tissue and is most commonly found in children. The study will use a treatment called ABTL0812, which is a capsule taken orally. This treatment contains an active substance known as sodium 2-hydroxylinoleate. The purpose of the study is to determine the best dose of ABTL0812 for children, both when used alone and in combination with other treatments like chemotherapy or targeted therapies.

Participants in the study will receive the treatment in cycles, and the study will monitor the effects of the treatment over time. The study aims to find out how well the treatment works and to identify any side effects that may occur. The trial will help researchers understand the safest and most effective way to use ABTL0812 in treating these types of cancers in children.

The study is expected to continue for several years, with an estimated end date in 2028. During this time, researchers will gather information to help improve treatment options for children with relapsed or refractory neuroblastoma and other solid tumors. This research is important for developing new therapies that can offer better outcomes for young patients facing these challenging conditions.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The trial begins with the administration of the study medication, ABTL0812, which is provided in capsule form. The medication is taken orally.

    The primary goal during this phase is to determine the recommended dose for children. This involves monitoring the body's response to the medication and identifying any side effects.

  2. Step 2

    Combination treatment phase

    In this phase, ABTL0812 may be combined with chemotherapy drugs such as irinotecan and temozolomide, or with targeted therapies.

    The combination aims to enhance the treatment's effectiveness against the solid tumors.

  3. Step 3

    Monitoring and assessment

    Throughout the trial, regular assessments are conducted to evaluate the treatment's impact on the tumor.

    These assessments include imaging tests to measure changes in the tumor size and blood tests to monitor overall health and organ function.

  4. Step 4

    End of treatment evaluation

    At the end of the treatment period, a comprehensive evaluation is performed to assess the overall effectiveness of the treatment.

    This includes reviewing all collected data to determine the incidence of any dose-limiting toxicities and the overall response of the tumor to the treatment.

Who can join the trial?

14 criteria

  • The patient, parents, or legal representatives must sign an informed consent form before any study-specific procedures begin. If the patient is old enough, they should also agree to participate.
  • The patient must be between 1 and 21 years old at the time of signing the consent form.
  • The patient must have a body surface area (BSA) of at least 0.5 square meters. BSA is a way to measure the size of the body.
  • The patient must be able to swallow whole capsules.
  • The patient must have a solid tumor that has either come back, not responded to treatment, or has no known cure. It's recommended, but not required, to confirm this with a tissue sample.
  • The patient must have at least one area of the disease that can be seen or measured using specific medical criteria.
  • The patient must have an adequate performance status, which means they should be able to perform daily activities to a certain extent. For patients under 16, this should be at least 60%. For those 16 and older, it should be more than 60% on the Karnofsky scale, which measures physical ability.
  • The patient must have adequate blood, liver, and kidney function, as shown by specific lab results taken within 7 days before starting the study drug. This includes:
    • Hemoglobin level of at least 8 grams per deciliter (g/dL). Blood transfusions are allowed.
    • A certain level of white blood cells and platelets without recent support from growth factors or transfusions.
    • Normal kidney function based on age and gender, or a certain level of creatinine clearance, which measures how well the kidneys are working.
    • Specific levels of bilirubin and liver enzymes, which indicate liver function.
    • Sexually active males and females of childbearing age must use appropriate birth control methods.
    • Females of childbearing age must have a negative pregnancy test.
    • The patient must not have any psychological, social, or geographical issues that could prevent them from following the study rules and schedule.

Who cannot join the trial?

4 criteria

  • Patients who have not been diagnosed with relapsed/refractory neuroblastoma or other solid tumors cannot participate. Relapsed/refractory means the cancer has come back or is not responding to treatment.
  • Patients who are not within the specified age range for the study cannot participate. The study is for certain age groups only.
  • Patients who are not eligible for the specific treatments being tested in the study cannot participate. This includes treatments like chemotherapy or targeted therapies.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

  • ABTL0812

    is an experimental medication being studied for its potential to treat children with relapsed or refractory neuroblastoma and other solid tumors. It is being tested to determine the appropriate dose for children when used alone or in combination with other treatments.

  • Irinotecan

    is a chemotherapy drug used to treat various types of cancer. In this trial, it is being combined with other therapies to see if it can help improve outcomes for children with certain solid tumors.

  • Temozolomide

    is another chemotherapy medication that is often used to treat brain tumors and other cancers. It is being tested in combination with other treatments to evaluate its effectiveness in children with relapsed or refractory neuroblastoma and other solid tumors.

What is already known about the treatment

ABTL0812 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory neuroblastoma and other solid tumors in children. It is in the experimental phase, with ongoing research to determine the recommended dose for pediatric patients, both as a standalone treatment and in combination with chemotherapy or targeted therapies. ABTL0812 works by inhibiting specific pathways that cancer cells use to grow and survive, thereby slowing down or stopping tumor progression. It is classified as an investigational anticancer agent.

Investigated diseases

  • Neuroblastoma

    Neuroblastoma is a type of cancer that most often affects children and develops from immature nerve cells found in several areas of the body. It commonly arises in and around the adrenal glands, but it can also develop in the abdomen, chest, neck, and near the spine. The disease can spread to other parts of the body, including lymph nodes, bones, bone marrow, liver, and skin. Symptoms may vary depending on the location of the tumor and can include abdominal pain, a lump in the abdomen, or changes in bowel habits. As the disease progresses, it may cause fatigue, loss of appetite, and weight loss. Neuroblastoma can be aggressive and may require intensive treatment.

  • Solid Tumors

    Solid tumors refer to abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs, muscles, and bones. Unlike blood cancers, solid tumors are characterized by the growth of abnormal cells that form a mass. The progression of solid tumors depends on their type, location, and growth rate. Symptoms can vary widely and may include pain, swelling, or a noticeable lump. As they grow, solid tumors can interfere with normal body functions and may spread to other areas.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-504246-64-00Protocol codeETNAEstimated enrolment48 patientsSponsorFir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron

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).