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Study of hu14.18K322A with temozolomide and irinotecan in children and adolescents with high‑risk neuroblastoma

Verified siteRegistered drugNo placebo
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What is this trial about?

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

The trial focuses on children with high-risk neuroblastoma that has returned (relapsed) or has not responded (refractory) to previous therapy. The experimental approach combines a new hu14.18K322A, which is a monoclonal antibody designed to help the immune system target the cancer, with standard cancer‑killing medicines. The chemotherapy drugs used in the study are temozolomide, Daretabart, and irinotecan. Neuroblastoma is a tumor that starts in nerve cells, often in the abdomen, and “high‑risk” indicates an aggressive form that needs strong treatment.

The purpose of the study is to evaluate whether the combination of the new protein and the chemotherapy works well and is safe for these patients. Participants receive the study drug by infusion (a slow drip into a vein) together with chemotherapy cycles given every few weeks. The treatment period lasts several months, with regular visits to check for side effects and to see how the tumor responds.

After the treatment phase, children are followed for a period of time to monitor disease behavior and record any long‑term effects. Blood tests, imaging scans, and physical examinations are used to assess progress, and any problems are managed by the medical team. The information gathered will help determine if this approach could become a new standard option for children with this serious condition.

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

    Baseline assessments

    after joining the trial, initial medical examinations are performed to record the current health status.

    laboratory tests, imaging studies, and other required evaluations are completed to establish a reference point before any medication is given.

  2. Step 2

    First treatment cycle

    on the scheduled treatment day, the following medicines are administered:

    dar​etabart: an intravenous (infusion) given at a dose of 60 mg/m².

    irinotecan: an intravenous (infusion) given at a dose of 50 mg/m².

    temodal: hard capsules taken orally at a dose of 100 mg/m².

    each medication is given according to the schedule defined by the trial protocol.

  3. Step 3

    Post‑treatment monitoring

    after the medicines are given, observation continues for a period of time to watch for any side effects.

    additional laboratory tests and clinical checks are performed to assess how the body is responding.

  4. Step 4

    Subsequent treatment cycles

    the same set of medicines (dar​etabart, irinotecan, and temodal) is repeated in later cycles as directed by the trial schedule.

    each cycle follows the same dosing amounts (60 mg/m², 50 mg/m², and 100 mg/m² respectively) and monitoring procedures.

  5. Step 5

    End‑of‑treatment assessment

    when the planned number of cycles is completed, a final set of evaluations is performed.

    these assessments compare the current health status with the baseline measurements to determine the effect of the treatment.

  6. Step 6

    Follow‑up period

    after treatment ends, regular follow‑up visits are scheduled to continue monitoring health and to detect any late effects.

    the schedule of these visits follows the trial protocol and may include physical exams, laboratory tests, and imaging.

Who can join the trial?

22 criteria

  • Be at least 18 months old but younger than 18 years.
  • Have been diagnosed with high‑risk neuroblastoma (a type of cancer) that has spread to other parts of the body (metastatic disease).
  • Have disease that can be seen or measured on scans according to standard criteria.
  • Have a performance status score of 50 or higher (Lansky score for younger children or Karnofsky score for older children), meaning you can perform most daily activities.
  • Have fully recovered from any side effects of previous chemotherapy, as judged by your doctors.
  • Be at least 2 weeks past any major tumor surgery and be fully healed from any surgical complications.
  • Have adequate organ function measured within one week before treatment:
    • Blood (bone marrow) function: platelets ≥50 × 10⁹/L and absolute neutrophil count ≥0.5 × 10⁹/L.
    • Kidney function: blood creatinine ≤1.5 times the age‑adjusted normal limit and an estimated glomerular filtration rate (eGFR) of at least 60 mL/min (calculated with the Schwartz formula).
    • Liver function: AST or ALT enzymes ≤3 times the normal limit (or ≤5 times if liver metastases are present) and total bilirubin ≤1.5 times normal.
    • Heart function: shortening fraction ≥27% or ejection fraction ≥50% on an ultrasound, and a QTc interval on an ECG ≤450 ms.
    • Lung function: normal oxygen level on room air (pulse oximetry) and no shortness of breath while at rest.
    • Central nervous system (CNS) function: no active disease in the brain or spinal cord, seizures must be well‑controlled if present, and no current brain toxicity.
    • Agree to pregnancy testing and, if applicable, use an acceptable method of birth control.
    • If you are a sexually active male, agree to use condoms.
    • Be willing and able to give written assent (your own agreement) to join the study.
    • Your parent or legal guardian must be willing and able to give written informed consent for you.
    • For participants in the relapse group:
      • Be experiencing your first or second relapse after having disease that was stable or responded (partial or complete) to previous therapy.
      • If you previously received anti‑GD2 therapy, the last dose must have been at least 14 days ago with no ongoing side effects.
      • If you had a stem‑cell transplant (myeloablative therapy), at least 6 weeks must have passed since the procedure.
      • For participants in the refractory group:
        • Your cancer must not have responded to at least four cycles of initial (induction) chemotherapy, but it also must not have gotten worse (no disease progression).
        • There must be at least one remaining metastatic lesion.
        • The primary tumor must be documented, and the disease must be measurable on imaging scans.

Who cannot join the trial?

23 criteria

  • Having an active infection that is not under control at the time you join the study, including a known history of HIV infection or a current or chronic infection with hepatitis C (HCV) or hepatitis B (HBV).
  • Any reason that makes the study medicines unsafe or unsuitable for you (a medical “contraindication”).
  • Having diarrhea that is worse than moderate (greater than Grade 2 severity).
  • Having disease affecting any major organ such as the heart, lungs, liver, or kidneys.
  • Having received a donor stem‑cell transplant (allogeneic transplant) within the past 6 months, or having had any solid organ transplant (for example, kidney, liver, or heart).
  • Being on hemodialysis, a treatment that uses a machine to clean your blood because your kidneys are not working well.
  • Needing, or likely to need, strong anti‑inflammatory medicines called systemic corticosteroids.
  • Taking any other medicines that lower your immune system (immunosuppressive medications).
  • Having taken seizure medicines that speed up the body’s drug‑processing enzymes (enzyme‑inducing anticonvulsants) for at least 7 days before joining the study.
  • Having been diagnosed with any cancer other than neuroblastoma.
  • Showing symptoms of congestive heart failure, a condition where the heart cannot pump blood effectively.
  • Having had a severe (Grade 4) allergic reaction to anti‑GD2 antibody therapy, or an allergic reaction that caused the treatment to be stopped permanently.
  • Being involved in another blinded (you don’t know which treatment you receive) or investigational medicinal product (IMP) study within 14 days (or five drug half‑lives) before screening or during this study.
  • Being a female who is breastfeeding, pregnant, or planning to become pregnant.
  • Not meeting the required “washout” period, which is the time you must wait after stopping other medicines before receiving the study drug hu14.18K322A.
  • Needing any medication that could interfere with the study treatment.
  • Having any other health condition that could make participation unsafe for you.
  • For the relapsed‑on‑treatment group: having disease that is only refractory (does not respond) to treatment.
  • For the relapsed‑on‑treatment group: having disease that gets worse during the initial (induction) phase of therapy.
  • For the relapsed‑on‑treatment group: not having stabilized or responded to previous anti‑GD2 monoclonal antibody (mAb) combined with chemotherapy.
  • For the refractory‑to‑treatment group: showing evidence that the primary tumor or metastatic sites (soft tissue or bone) are progressing (growing).
  • For the refractory‑to‑treatment group: having started later phases of therapy such as consolidation or maintenance treatment.
  • For the refractory‑to‑treatment group: having received anti‑GD2 monoclonal antibody therapy before.
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Investigated drugs

  • Temodal

    is a capsule that contains temozolomide, a type of chemotherapy drug. It works by damaging the DNA inside cancer cells, which stops the cells from growing and helps them die. In this study, temozolomide is given together with other treatments to try to improve the outcome for children with high‑risk neuroblastoma.

  • Daretabart

    is a specially designed antibody (hu14.18K322A) that seeks out a substance called GD2 found on the surface of neuroblastoma cells. By binding to GD2, the antibody flags the cancer cells so the body’s immune system can recognize and attack them. It is given by an IV infusion and is being tested as a new targeted therapy to work alongside standard chemotherapy.

  • Ir

    inotecan is a chemotherapy medicine that interferes with the way cancer cells copy their DNA, making it difficult for them to multiply. It is administered through an IV infusion and is combined with the other drugs in the trial to see if the combination can better control or shrink the neuroblastoma.

What is already known about the treatment

  • Temodal

    Temodal is taken as hard capsules by mouth. It is an approved chemotherapy drug that has been used for many years, especially for brain tumors, and is well described in medical literature. It works by adding a small chemical group to the DNA of cancer cells, which stops them from dividing and leads to their death. It belongs to the class of alkylating agents, which are drugs that damage DNA.

  • Daretabart

    Daretabart is given as an intravenous infusion, meaning it is delivered directly into a vein through a drip. It is an experimental orphan drug still being studied, with limited published data outside clinical trials. The antibody is designed to bind to a molecule called GD2 on the surface of neuroblastoma cells, marking them for attack by the immune system. It is classified as a monoclonal antibody immunotherapy.

  • Irinotecan

    Irinotecan is administered by intravenous infusion, where the medication is injected into a vein over a short period. It is an approved chemotherapy agent used mainly for colon cancer and is also studied for other cancers, so it is well documented in the literature. It blocks an enzyme called topoisomerase I, which cancer cells need to copy their DNA, thereby stopping their growth. It is classified as a topoisomerase I inhibitor, a type of chemotherapy drug.

Investigated diseases

  • Relapsed high‑risk neuroblastoma

    Neuroblastoma is a cancer that starts in nerve‑tissue cells, usually in the adrenal gland or abdomen, and is classified as high‑risk when it spreads widely or has unfavorable genetic features. Relapse means the disease returns after an initial period of improvement, often showing new tumor growth or spread to other areas. The recurring tumors tend to grow quickly and may appear in the same location or in new sites such as bone or bone marrow. Symptoms can include pain, fatigue, or swelling where the cancer reappears. The condition continues to progress as cancer cells multiply until further intervention is taken.

  • Refractory high‑risk neuroblastoma

    High‑risk neuroblastoma that is refractory does not respond to standard chemotherapy or other initial treatments. The disease remains active and can continue to enlarge or spread despite therapy. Cancer cells keep dividing, leading to new tumor masses or involvement of distant organs like the liver, lungs, or bones. Patients may notice persistent or worsening symptoms such as abdominal fullness or bone pain. The illness advances as unchecked tumor growth persists.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-524397-42-00Protocol codeEPG-HU1418-201Estimated enrolment203 patients

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