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Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma

NCT04560166 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2024-03-18

Study results available
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Summary

An International, Single-Arm, Multicenter Phase 2 Trial.

Conditions

  • Neuroblastoma Recurrent

Interventions

DRUG

Naxitamab and GM-CSF in combination with irinotecan and temozolomide

* Irinotecan, solution for infusion (20 mg/mL) * Temozolomide, capsules (5 mg, 20 mg and 100 mg) * The humanized immunoglobulin isotype G (IgG1) monoclonal antibody (mAb) naxitamab, solution for infusion (4 mg/mL) * Sargramostim (GM-CSF), lyophilized 250 µg single use vial (250 µg/vial)

Sponsors & Collaborators

  • Y-mAbs Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-08
Primary Completion
2022-09-21
Completion
2022-09-21
FDA Drug
Yes

Countries

  • Hong Kong
  • South Korea

Study Locations

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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 NCT04560166 on ClinicalTrials.gov