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Monoclonal Antibodies

Naxitamab for High-Risk Neuroblastoma

Phase 2

Recruiting

Research Sponsored by Y-mAbs Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

High-risk neuroblastoma patients with either primary refractory disease or incomplete response to salvage treatment (including stable disease, minor response, and partial response) evaluable in bone and/or bone marrow

Diagnosis of neuroblastoma as defined per International Neuroblastoma Response Criteria

Must not have

Evaluable neuroblastoma outside bone and bone marrow

Active life-threatening infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is for children and adults with high-risk neuroblastoma who have either not responded well to initial treatment (primary refractory disease) or who have relapsed after treatment (incomplete response to salvage treatment). The treatment involves naxitamab, which is a humanised monoclonal antibody targeting GD2, and granulocyte-macrophage colony stimulating factor (GM-CSF). Patients will receive treatment for up to 101 weeks and will be followed for up to five years after their first dose.

Who is the study for?

This trial is for children and adults with high-risk neuroblastoma that hasn't fully responded to previous treatments or is considered refractory. Participants should have a life expectancy of at least 6 months and their disease must be present in the bone or bone marrow, but not outside these areas. They shouldn't have had cancer therapy within the last 3 weeks and must not have severe organ dysfunction or active serious infections.

What is being tested?

The study tests naxitamab combined with GM-CSF in patients with high-risk neuroblastoma over a period of up to 101 weeks. Naxitamab is an antibody targeting GD2 on cancer cells, while GM-CSF helps boost the immune system's response against the tumor.

What are the potential side effects?

Potential side effects may include allergic reactions due to naxitamab, as well as various immune-related responses because of both drugs' action on the body's defense systems. Side effects can range from mild to severe and could affect different organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My neuroblastoma is high-risk and hasn't fully responded to treatment.

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I have been diagnosed with neuroblastoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My neuroblastoma is detectable outside of my bones and bone marrow.

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I do not have a severe infection that is putting my life at risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response rate during Naxitamab treatment

Secondary study objectives

Assessment of anti-drug antibody (ADA) formation

Assessment of the Area under the Curve (AUC) of naxitamab

Assessment of the clearance of naxitamab

+17 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: GM-CSF + NaxitamabExperimental Treatment1 Intervention

Each investigational cycle is started with 5 days of GM-CSF administered at 250 µg/m2/day in advance of the start of Naxitamab administration. GM-CSF is thereafter administered at 500 µg/m2/day on days 1 to 5. As standard treatment, Naxitamab is administered at 3 mg/kg/day on days 1, 3, and 5 totalling 9 mg/kg per cycle. Treatment cycles are repeated every 4 weeks until CR or PR followed by 5 additional cycles every 4 weeks (±1 week). Subsequent cycles are repeated every 8 weeks (±2 weeks) through 101 weeks from first infusion at the discretion of the investigator. After end of treatment patients will enter a long-term follow up for up to 3 years after end of treatment visit.

0 / 4Eligibility criteria met