CI

At a glance

ClinicalIndex Comparison Record
Phase 1Terminated· 12 enrolled / 12 target
Drug / intervention
Dinutuximab +7 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04751383
NCT04751383Phase 1TerminatedUpdate Overdue (0.2/mo)Completion was 21mo ago
Terminated

Phase 1 Trial of Hu5F9-G4 (Magrolimab) Combined With Dinutuximab in Children and Young Adults With Relapsed and Refractory Neuroblastoma or Relapsed Osteosarcoma

National Cancer Institute (NCI)·interventional·Posted Feb 12, 2021·Updated Jun 30, 2026

In Brief

A Phase 1 clinical trial evaluating Biospecimen Collection, Bone Marrow Aspiration, and 6 other interventions for High Risk Neuroblastoma and 4 related conditions. Terminated early, enrolled 12 participants across 11 sites in 2 countries.

Signals

Trial was terminated early
Enrollment appears stalled

Detailed Summary

This phase I trial is to find out the best dose, possible benefits and/or side effects of magrolimab in combination with dinutuximab in treating patients with neuroblastoma that has come back (relapsed) or does not respond to treatment (refractory) or relapsed osteosarcoma. Magrolimab and dinutuximab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. The combination of magrolimab and dinutuximab may shrink or stabilize relapsed or refractory neuroblastoma or relapsed osteosarcoma. In addition, this trial may help researchers find out if it is safe to give magrolimab and dinutuximab after surgery to remove tumors from the lungs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 1TerminatedFinished
202120222023202420252026
First PostedFeb 12, 2021
Enrollment StartAug 31, 2021
Primary CompletionSep 30, 2024
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 5.4 years ago

Arms & Interventions

Arm A (magrolimab, dinutuximab)experimental

Patients receive magrolimab IV and dinutuximab IV on study. Patients also undergo CT, MRI, and blood sample collection on study, as well as bone marrow aspiration and biopsy throughout the trial.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyProcedure: Computed TomographyBiological: DinutuximabProcedure: Magnetic Resonance ImagingBiological: Magrolimab
Arm B (magrolimab, dinutuximab, surgery)experimental

Patients receive magrolimab IV and dinutuximab IV on study. Patients with pulmonary osteosarcoma may undergo surgical resection of tumor after cycle 1. After surgery, these patients continue receiving magrolimab and dinutuximab on study. Patients also undergo CT, MRI, and collection of blood samples on study, as well as bone marrow aspiration and biopsy throughout the trial.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyProcedure: Computed TomographyBiological: DinutuximabProcedure: Magnetic Resonance ImagingBiological: MagrolimabProcedure: Resection

Interventions

Biospecimen Collectionprocedure

Undergo collection of blood samples

Bone Marrow Aspirationprocedure

Undergo bone marrow aspiration

Bone Marrow Biopsyprocedure

Undergo bone marrow biopsy

Computed Tomographyprocedure

Undergo CT

Dinutuximabbiological

Given IV

Magnetic Resonance Imagingprocedure

Undergo MRI

Magrolimabbiological

Given IV

Resectionprocedure

Undergo surgical resection