NCT07027748

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Steven DuBois, MD · Academic / Other
• Sex: All
• Age: 1 Year – 30 Years
• Healthy volunteers: Not accepted

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)

Detailed description

This phase 1, single treatment arm, prospective trial is designed to identify the maximally safe infusion duration of Naxitamab in combination with Irinotecan, Sargramostim, and Temozolomide for participants with relapsed, refractory, progressive neuroblastoma. Study doctors are studying different Naxitamab infusion duration levels (how quickly the drug is given into the vein) to determine if this makes a difference in side effects such as pain or infusion reactions. Not every participant in this research study will receive the same infusion duration of the study drug, Naxitamab. The infusion duration received will depend on the number of participants who have been enrolled in the study and how well an infusion duration is tolerated. The duration groups will be as follows: * Duration Level -1: Naxitamab infusion duration will be 5 hours * Duration Level 1: Naxitamab infusion duration will be 4 hours * Duration Level 2: Naxitamab infusion duration will be 3 hours The U.S. Food and Drug Administration (FDA) has approved Naxitamab for patients aged greater than 1 year with relapsed/refractory neuroblastoma in the bone or bone marrow. The research study procedures include screening for eligibility, in-clinic visits, questionnaires, blood tests, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Meta-Iodine odobenzylguanidine (MIBG) scans, echocardiograms (ECGs), bone marrow aspiration/biopsies. It is expected that about 18 people will take part in this research study. YmAbs Therapeutics is supporting this research study by providing naxitamab for the trial and support to measure naxitamab blood levels.

Conditions

• Neuroblastoma
• Neuroblastoma Recurrent
• Relapsed Neuroblastoma
• Refractory Neuroblastoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-06-27
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2025-06-18
• Last updated: 2025-07-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study