drugset / Trial / NCT04560166

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

NCT04560166 ↗

Phase 2 Terminated 2 enrolled Y-mAbs Therapeutics
NaSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start
2021-11-08
Primary completion
2022-09-21
Completion
2022-09-21

Outcome

Met primary endpoint

Stopped (Business): “Due to business priorities”

release “The primary endpoint was reached in the MSK phase 2 trial” serb.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 50 mg/m2 Intravenous
Subject Naxitamab Monoclonal antibody 2.25 mg/kg Intravenous
Subject Temozolomide Small molecule 100 mg/m2 Oral
Subject sargramostim Protein / enzyme biologic 250 ug/m2 Subcutaneous

Indications