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New antibody combo shows promise for tough childhood cancer

NCT ID NCT03363373

Disease control Sponsor: Y-mAbs Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This phase 2 trial tests a combination of two drugs—naxitamab (an antibody) and GM-CSF (an immune booster)—in children and adults with high-risk neuroblastoma that has not responded well to previous treatments. The goal is to see if this therapy can shrink or eliminate tumors in the bone and bone marrow. Participants receive treatment for up to 101 weeks and are followed for five years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Naxitamab (a lab-made antibody) and GM-CSF (a protein that boosts immune cells)
What this could lead to
If successful, this could offer a new treatment option for patients with high-risk neuroblastoma that has not responded to standard therapy.
What could go wrong
This is a phase 2 trial with 122 participants, so results are still preliminary. The treatment may cause side effects, and not all patients may respond.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 122 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2018

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of neuroblastoma as defined per International Neuroblastoma Response Criteria * High-risk neuroblastoma patients with either primary refractory disease or incomplete response to salvage treatment (in both cases including stable disease, minor response and partial response) evaluable in bone and/or bone marrow. * Life expectancy ≥ 6 months Exclusion Criteria: * Any systemic anti-cancer therapy, including chemotherapy or immunotherapy, within 3 weeks before 1st dose of GM-CSF * Evaluable neuroblastoma outside bone and bone marrow * Existing major organ dysfunction \> Grade 2, with the exception of hearing loss, hematological status, kidney and liver function * Active life-threatening infection

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Conditions

The condition(s) this trial relates to.

neuroblastoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neuroblastoma

Contacts and locations

Locations

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Milan, 20133, Italy

  • Giannina Gaslini Hospital

    Genoa, Genoa, 16147, Italy

  • Hong Kong Children's Hospital

    Hong Kong, Hong Kong

  • Hospital Infantil Universitario Niño Jesús

    Madrid, 28009, Spain

  • Hospital Sant Joan de Déu

    Barcelona, 08950, Spain

  • Hospital Universitario Virgen Del Rocío

    Seville, Spain

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46026, Spain

  • Johannes Gutenberg-Universität

    Mainz, Germany

  • Leeds General Infirmary

    Leeds, LS1 3EX, United Kingdom

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Ospedale Pediatrico Bambino Gesù

    Rome, Italy

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202, United States

  • Tata Memorial Centre

    Mumbai, 400012, India

  • The Hospital for Sick Children

    Toronto, M5G 1X8, Canada

  • The Royal Glasgow Children's Hospital

    Glasgow, G51 4TF, United Kingdom

  • University Hospital Regensburg

    Regensburg, Germany

  • University Hospital Southampton

    Southampton, SO16 6YD, United Kingdom

  • University Medical Center Hamburg-Eppendorf

    Hamburg, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.