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Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma

NCT07027748 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-07-14

No results posted yet for this study

Summary

This research is being done to investigate a treatment regimen of Irinotecan, Temozolomide, and Sargramostin, and an immunotherapy called Naxitamab and whether giving Naxitamab more slowly reduces the side effects for participants with relapsed or refractory neuroblastoma.

The name of the study drugs involved in this study are:

* Naxitamab (A type of monoclonal antibody)
* Irinotecan (A standard of care chemotherapy)
* Temozolomide (A standard of care chemotherapy)
* Sargramostim (A standard of care, granulocyte-macrophage colony stimulating factor)

Conditions

  • Neuroblastoma
  • Neuroblastoma Recurrent
  • Relapsed Neuroblastoma
  • Refractory Neuroblastoma

Interventions

DRUG

Naxitamab

Recombinant humanized anti-GD2 monoclonal antibody, single-use vial, via intravenous (into the vein) infusion per protocol.

DRUG

Irinotecan

Topoisomerase Inhibitor, single-dose vial, via intravenous infusion per standard of care

DRUG

Temozolomide

Alkylating agent, capsule, via orally (by mouth) per standard of care

DRUG

Sargramostim granulocyte-macrophage colony stimulating factor

Recombinant human granulocyte-macrophage colony stimulating factor (rhu GM-CSF), multi-use vial, via subcutaneously (under the skin) injection per standard of care

Sponsors & Collaborators

  • Y-mAbs Therapeutics

    collaborator INDUSTRY

  • Steven DuBois, MD

    lead OTHER

Principal Investigators

  • Steven DuBois, MD, MS · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-27
Primary Completion
2026-12-01
Completion
2027-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07027748 on ClinicalTrials.gov