Can an antibody drug outsmart resistant Ewing's sarcoma?

NCT ID NCT05968768

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This phase 2 trial is testing whether adding the antibody drug naxitamab to standard chemotherapy can help children and young adults with Ewing's sarcoma that has not responded to prior treatment. Participants must have a tumor that shows a specific marker called GD2. The study will measure safety, how long people live without the disease getting worse, and whether tumors shrink.

What this could mean

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

Active substance
naxitamab (also known as danyelza), an antibody drug given alongside standard chemotherapy
What this could lead to
If it works, adding naxitamab to standard chemotherapy could offer a new treatment option for people with Ewing's sarcoma that has not responded to other treatments.
What could go wrong
This is a small, early-phase trial, so the benefits are uncertain. Naxitamab can cause serious allergic reactions and other side effects, and it may not improve outcomes for everyone.

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 24 people

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

Started

Oct 2023

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

2 to 21 years

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: 1. Histologically proven Ewing sarcoma of the bone or soft tissues. 2. Subject's archival tumour sample (formalin-fixed, paraffin-embedded; FFPE) available for evaluation of GD2 expression. 3. Documented disease progression (during or after completion of at least one line treatment) or any subsequent recurrence. 4. GD2 positive tumor assessed by IHC. 5. Age ≥ 2 years and ≤ 21 years. 6. Life expectancy of at least 12 weeks from the time informed consent was signed. 7. Previous systemic anticancer treatment completed ≥ 3 weeks, major surgery ≥ 2 weeks, and radiation therapy ≥ 4 weeks prior to study enrollment. 8. Recovered from adverse effects of prior surgery, radiotherapy, or Clinical trial protocol BUTTERFLY version 1.0 of 30.09.2022 r.anti-neoplastic therapy at the discretion of the investigator. 9. Signing of informed consent for trial participation (including for naxitamab treatment) according with current legal regulations. 10. Consent to the use of effective contraception throughout the period of the study and a minimum of 1 year after discontinuation of study treatment in patients at puberty and sexual maturity Exclusion Criteria: 1. Failure to meet any of the inclusion criteria. 2. Not eligible to IT. 3. Previous treatment with an anti-GD2 antibody. 4. Hypersensitivity to the study drugs or any of their ingredients (covers IT and naxitamab). 5. Simultaneous treatment with other drugs which might interact with naxitamab or IT regimen. 6. Persistent toxicity related to prior therapy, making it impossible to treat with naxitamab. 7. Significant cardiac conduction abnormalities, including known familial prolonged QT syndrome, or screening corrected QT interval (QTc) \>480 msec. 8. Symptoms of congestive heart failure or left ventricular ejection fraction \<50%. 9. Inadequate pulmonary function defined as evidence of dyspnea at rest, exercise intolerance, and/or chronic oxygen requirement. In addition, room air pulse oximetry \< 94% and/or abnormal pulmonary function tests if these assessments are clinically indicated. 10. Requirement, or likely requirement, for corticosteroids at doses \>10 mg prednisolone (or equivalent) per day or other immunosuppressive agents. 11. Diagnosis of other malignancies before study inclusion. 12. Planning to become pregnant (while being treated with IT or naxitamab), pregnancy or breastfeeding. 13. Other acute or persistent disorders, behaviors or abnormal laboratory test results, which might increase the risk related to the participation in this clinical trial or to taking the study drug, or which might influence the interpretation of the study results, or which, in the investigator's opinion, disqualify a patient from participating in the tri

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mother and Child Institute

    RECRUITING

    Warsaw, Mazowian, 01-211, Poland

  • Wroclaw Medical University

    NOT_YET_RECRUITING

    Wroclaw, 50-556, Poland

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