drugset / Trial / NCT05489887

Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma

NCT05489887

Phase 2 Recruiting 93 enrolled Giselle Sholler Y-mAbs Therapeutics · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a prospective, multicenter clinical trial in subjects with newly diagnosed high-risk neuroblastoma to evaluate the efficacy and safety of administering naxitamab with standard induction therapy. The initial chemotherapy will include 5 cycles of multi-agent chemotherapy. Naxitamab will be added to all 5 Induction cycles. We hypothesize that the addition of anti-GD2 therapy to induction chemotherapy will result in improved end of induction responses and improved survival.

Timeline

Start
2022-09-14
Primary completion
2029-09
Completion
2036-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Naxitamab Monoclonal antibody

Indications