Naxitamab

Summary

Naxitamab (CHEMBL4297984) is an approved antibody (ATC L01FX21); indicated across 5 conditions including neuroblastoma and neoplasm.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: L01FX21
• Indications: 5 conditions
• Clinical trials: 19

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4297984
Name	Naxitamab
Type	Antibody
Max phase	4
ATC	L01FX21

Also known as: Danyelza, Hu3f8, Humanized 3f8, Hu3F8, Monoclonal antibody hu3f8, Naxitamab, Naxitamab gqgk, Naxitamab-gqgk, NAXITAMAB

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

2 approved indications. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
neuroblastoma	4	MONDO:0005072	EFO:0000621
neoplasm	4	MONDO:0005070	EFO:0000616

3 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
Ewing sarcoma	2	MONDO:0012817	EFO:0000174
breast carcinoma	1	MONDO:0004989	EFO:0000305
breast neoplasm	1	MONDO:0021100	MONDO:0007254

Clinical trials

Total trials: 19.

Phase distribution

Phase	Trials
PHASE2	12
PHASE1/PHASE2	2
PHASE1	2
PHASE4	1
EARLY_PHASE1	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06047535	PHASE4	NOT_YET_RECRUITING	Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Combined With Isotretinoin for Maintenance Treatment of Patients With High-Risk Neuroblastoma in First Complete Response.
NCT03363373	PHASE2	RECRUITING	Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow
NCT05489887	PHASE2	RECRUITING	Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma
NCT05754684	PHASE2	RECRUITING	Quadruple Immunotherapy for Neuroblastoma
NCT05968768	PHASE2	RECRUITING	To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing’s Sarcoma (Butterfly)
NCT06013618	PHASE2	RECRUITING	Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma
NCT06026657	PHASE1/PHASE2	RECRUITING	Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells With or Without Naxitamab (Danyelza) for the Treatment of Patients With Metastatic, GD2 Expressing, HER2 Negative Breast Cancer
NCT06528496	PHASE2	RECRUITING	N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma
NCT06540963	PHASE2	RECRUITING	Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma
NCT07011654	PHASE1/PHASE2	RECRUITING	Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)
NCT07537400	PHASE2	NOT_YET_RECRUITING	Patients 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 1-5
NCT03033303	PHASE2	COMPLETED	A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma
NCT04560166	PHASE2	TERMINATED	Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma
NCT04909515	PHASE2	WITHDRAWN	Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.
NCT06438614	PHASE2	COMPLETED	A Study Of Naxitamab , Granulocyte Macrophage Colony Stimulating Factor For Patients With Relapsed /Refractory , Soft Tissue or Anti GD2 Immunotherapy Refractory Neuroblastoma
NCT07027748	PHASE1	RECRUITING	Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma
NCT02650648	PHASE1	COMPLETED	Humanized Anti-GD2 Antibody Hu3F8 and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma
NCT03189706	EARLY_PHASE1	ACTIVE_NOT_RECRUITING	Study of Chemoimmunotherapy for High-Risk Neuroblastoma
NCT04501757	Not specified	NO_LONGER_AVAILABLE	Naxitamab and GM-CSF in People With Neuroblastoma

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).