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Naxitamab

Phase 2

High-Risk Neuroblastoma | Small molecule | Oncology |Y-mAbs Therapeutics, Inc.|Last Updated: Apr 17, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07537400Patients Between the Ages of 12 Months to 21 Years With Newly-Diagnosed High-Risk Neuroblastoma Will Receive Children's Oncology Group (COG) Type Recommended Therapy With the Addition of Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) to Induction Cycles 1-5PHASE2 NOT YET_RECRUITING 10 — — May 1, 2026Apr 1, 2032Apr 17, 20261 Israel
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Study Endpoints
Primary Endpoints
Evaluate the safety of chemoimmunotherapy with Naxitamab and COG-type induction chemotherapy in newly diagnosed patients with high-risk neuroblastoma
Post 2nd course, and post 5th course of chemoimmunotherapy (therapy lasts approximately 4 and a half months)

This measure will be assessed by evaluating treatment side effects.

Assess end-of-induction (EOI) response rates following concurrent Naxitamab and induction chemotherapy in newly diagnosed patients with high-risk neuroblastoma.
Post 5th course of chemoimmunotherapy (therapy lasts approximately 4 and a half months)

This measure will be assessed using the 1993 International Neuroblastoma Response Criteria (INRC) criteria.

Assess end-of-induction (EOI) response rates following additional cycles of Irinotecan-Temodar-Naxitamab-GM-CSF in patients with high risk neuroblastoma and less than partial response (PR) after induction with COG type chemotherapy and Naxitamab
Post 5th course of chemoimmunotherapy (therapy lasts approximately 4 and a half months)
Secondary Endpoints
Determine event-free survival (EFS) in newly diagnosed high-risk neuroblastoma patients
From enrollment until completion of follow-up, 5 years from diagnosis
Metastatic complete response after cycle 2 and at end of induction.
Post 2nd course, and post 5th course of induction therapy (therapy lasts approximately 4 and a half months)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Naxitamab and GM-CSFEXPERIMENTALAll enrolled patients receive Naxitamab and GM-CSF in combination with induction therapy for newly-diagnosed high-risk neuroblastoma
Interventions
NameTypeDescription
NaxitamabDRUGNaxitamab and GM-CSF administered with COG type induction chemotherapy.
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Eligibility Criteria
Age Range12 Months — 21 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Age - 12 months to 21 years at protocol enrollment * Clinical eligibility criteria: 1. Newly diagnosed high risk neuroblastoma. 2. BOTH stage M (INRG - International Neuroblastoma Risk Group) and age ≥547 days. 3. Patients ≥ 547 days of age who were initially diagnosed ...

Countries:Israel
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07537400studyFirstPostDate: changed
LOWMay 21, 2026NCT07537400NEW_TRIAL: changed
LOWMay 21, 2026NCT07537400NEW_TRIAL: changed