Dinutuximab

Summary

Dinutuximab (CHEMBL3137342) is an approved antibody (ATC L01FX06); indicated across 7 conditions including neuroblastoma and neoplasm.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: L01FX06
• Indications: 7 conditions
• Clinical trials: 27

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL3137342
Name	Dinutuximab
Type	Antibody
Max phase	4
ATC	L01FX06

Also known as: Ch14.18, Dinutuximab, Unituxin, DINUTUXIMAB

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

7 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
neuroblastoma	4	MONDO:0005072	EFO:0000621
neoplasm	4	MONDO:0005070	EFO:0000616
ganglioneuroblastoma	3	MONDO:0005035	EFO:0000502
osteosarcoma	2	MONDO:0009807	EFO:0000637
small cell lung carcinoma	2	MONDO:0008433	EFO:0000702
leiomyosarcoma	2	MONDO:0005058	EFO:0000564

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 27.

Phase distribution

Phase	Trials
PHASE2	9
PHASE1	6
PHASE3	5
PHASE1/PHASE2	5
PHASE2/PHASE3	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT01704716	PHASE3	RECRUITING	High Risk Neuroblastoma Study 1.8 of SIOP-Europe (SIOPEN)
NCT03126916	PHASE3	RECRUITING	Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
NCT06172296	PHASE3	RECRUITING	Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
NCT00026312	PHASE3	COMPLETED	Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma
NCT01041638	PHASE3	COMPLETED	Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma
NCT03098030	PHASE2/PHASE3	COMPLETED	Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer
NCT03786783	PHASE2	ACTIVE_NOT_RECRUITING	Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma
NCT03794349	PHASE2	ACTIVE_NOT_RECRUITING	Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma
NCT04211675	PHASE1/PHASE2	RECRUITING	NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
NCT04385277	PHASE2	ACTIVE_NOT_RECRUITING	Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL)
NCT06450041	PHASE2	RECRUITING	NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial
NCT07261241	PHASE2	NOT_YET_RECRUITING	NANT 2021-02: Randomized MIBG With Vorinostat/Dinutuximab/Vorinostat + Dinutuximab
NCT07437963	PHASE1/PHASE2	NOT_YET_RECRUITING	Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse
NCT01592045	PHASE1/PHASE2	COMPLETED	ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma
NCT01701479	PHASE1/PHASE2	UNKNOWN	Long Term Continuous Infusion ch14.18/CHO Plus s.c. Aldesleukin (IL-2)
NCT01767194	PHASE2	COMPLETED	Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma
NCT02258815	PHASE2	COMPLETED	CH14.18 1021 Antibody and IL2 After Haplo SCT in Children With Relapsed Neuroblastoma
NCT02484443	PHASE2	COMPLETED	Dinutuximab in Combination With Sargramostim in Treating Patients With Recurrent Osteosarcoma
NCT02641782	PHASE2	TERMINATED	NB2013-HR German (GPOH) / Dutch (DCOG) Trial
NCT04238819	PHASE1/PHASE2	COMPLETED	A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma
NCT01711554	PHASE1	ACTIVE_NOT_RECRUITING	Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma
NCT02573896	PHASE1	ACTIVE_NOT_RECRUITING	Immunotherapy of Relapsed Refractory Neuroblastoma With Expanded NK Cells
NCT02914405	PHASE1	ACTIVE_NOT_RECRUITING	Phase I Study of 131-I mIBG Followed by Nivolumab & Dinutuximab Beta Antibodies in Children With Relapsed/Refractory Neuroblastoma
NCT01704872	PHASE1	COMPLETED	ch14.18/CHO Bridging Study
NCT03332667	PHASE1	COMPLETED	MIBG With Dinutuximab +/- Vorinostat
NCT04751383	PHASE1	COMPLETED	Testing the Combination of Two Immunotherapy Drugs (Magrolimab and Dinutuximab) in Patients With Relapsed or Refractory Neuroblastoma or Relapsed Osteosarcoma
NCT02693171	Not specified	TERMINATED	Post-Marketing Assessment of Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients

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).