AuthorisedTherapeutic exploratory (Phase II)Interventional

A Phase II Study of Naxitamab Added to Induction Therapy for Subjects with Newly Diagnosed High-Risk Neuroblastoma

This medical study is investigating a new treatment, Naxitamab, for patients who have recently been diagnosed with high-risk neuroblastoma, a type of cancer that usually affects children. Naxitamab is a special type of antibody designed to target cancer cells. Researchers want to find out if adding Naxitamab to the patient's existing initial treatment plan (called induction therapy) leads to better outcomes. Specifically, they are looking to see how many patients have their cancer disappear or shrink significantly after this first phase of treatment. This is a Phase II study, meaning it's an early-stage trial focused on checking if the new treatment is effective and safe enough to continue with further research.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fundacio Sant Joan De Deu

Enrolment target

Start

19 May 2026

Neuroblastoma or ganglioneuroblastoma (nodular or intermixed)

What is this study about?

This study is about a type of cancer called neuroblastoma, which mostly affects children. If a child is diagnosed with 'high-risk' neuroblastoma, it means the cancer is more serious and may be harder to treat. Doctors are always looking for better ways to treat this condition, and this study focuses on a new medication called Naxitamab.

Naxitamab is a medication that works like a natural substance in your body called an antibody. These antibodies are designed to find and fight specific things, in this case, certain components on the neuroblastoma cancer cells. The idea is that Naxitamab could help the standard first treatment, called 'induction therapy,' which patients already receive, work even better.

Researchers want to see if adding Naxitamab to the usual induction therapy can cause the cancer to shrink or even disappear more often. They will carefully check how well the treatment works at the end of this initial treatment phase. This is an important step in finding new and more effective ways to help children with neuroblastoma.

Key takeaways

This study is for people recently diagnosed with high-risk neuroblastoma.
It's testing a new medication called Naxitamab alongside standard initial treatment.
The main goal is to see if Naxitamab helps shrink or get rid of the cancer more effectively.
This is an early-stage study, aiming to find better ways to treat neuroblastoma.
Participants will receive the usual care plus the study medication and be carefully monitored.

Who may be eligible?

To be part of this study, participants must be at least 18 years old. There is no upper age limit, meaning adults of any age can potentially join.

Both males and females are welcome to participate in this study. The study is specifically for individuals who have been recently diagnosed with certain types of neuroblastoma or a related condition called ganglioneuroblastoma (nodular or intermixed types).

There will be other detailed medical criteria that your doctor will need to check to make sure the study is a safe and suitable option for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Have you been recently diagnosed with neuroblastoma or ganglioneuroblastoma?
Are you willing to have an additional study medication (Naxitamab) with your usual treatment?
Are you able to attend regular hospital visits for assessments and treatment?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve adding the study medication, Naxitamab, to your standard initial treatment for neuroblastoma. This first stage of treatment is called 'induction therapy.'

You would have regular assessments and visits with the study team. These visits would include check-ups, scans, and tests to see how you are responding to the treatment and to monitor your health. The duration of your participation would depend on your treatment plan and how you respond, but the focus initially will be on the 'end-of-induction' period, which is when the main measurements of the study are taken.

After this initial treatment phase, there would likely be further follow-up appointments to monitor your progress over a longer period. The study team will explain the full schedule of visits, tests, and medication administration.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of joining this study is that you might receive a new treatment, Naxitamab, which could potentially improve how well your neuroblastoma responds to the initial therapy. However, there's no guarantee it will work for everyone, and it's possible it won't offer any extra benefit over existing treatments. All medicines can have side effects, and Naxitamab is no exception. The study team will explain the known and potential side effects of Naxitamab, and you would be closely monitored for any reactions during your treatment. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Spain

Common questions

What is neuroblastoma?

Neuroblastoma is a type of cancer that usually affects young children. It develops from nerve cells found in several areas of the body, most commonly in the adrenal glands.

What is 'induction therapy'?

Induction therapy is the first stage of treatment for cancer, often using chemotherapy, to try to shrink the cancer as much as possible before further treatments.

What is Naxitamab?

Naxitamab is a special type of drug called an antibody that is designed to attach to specific cancer cells and help the body's immune system fight them.

What does 'Phase II study' mean?

A Phase II study is an early stage of clinical research where doctors test if a new treatment is effective and safe enough to move on to larger studies and potentially become a standard treatment.

Will I still receive my usual treatment?

Yes, if you join this study, the Naxitamab treatment will be given in addition to your standard initial treatment (induction therapy).