Skip to main content

dinutuximab

Generic: dinutuximab·Brand: Unituxin

dinutuximab: developed by 1 company · 8 clinical trials tracked.

dinutuximab evidence translation

What we can confirm

What it means

Source-backed records connect dinutuximab to UTHR; that link alone does not prove the drug works.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

How could dinutuximab → UTHR affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence3 indications · 2 study sponsors
Development Pipeline (1)
CompanyPhase
UNITED THERAPEUTICS Corp (UTHR)
High-risk neuroblastoma
Approved
Clinical Trials (8)

NANT 2021-02: A Randomized Phase 2 Study of 131I-MIBG With Vorinostat VS. 131I-MIBG With Dinutuximab vs. 131I-MIBG With Dinutuximab and Vorinostat for Relapsed or Refractory Neuroblastoma

NCT07261241·Phase 2
Not yet recruiting

Primary endpoint: Objective Tumor Response After One Course of Therapy

InterventionalRandomizedopen118 targetStarted 2026-12Completion 2031-1213 sites · United StatesNew Approaches to Neuroblastoma Therapy Consortium

Phase II Study of Ex-Vivo Expanded Allogeneic Universal Donor TGFβi NK Cell Infusions in Combination With Temozolomide, Irinotecan, Dinutuximab, and Sargramostim in Patients With Relapsed or Refractory Neuroblastoma The STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial

NCT06450041·Phase 2
Recruiting

Primary endpoint: Best Overall Response Rate of Evaluable Patients

Interventionalopen62 targetStarted 2024-12Completion 2038-1213 sites · United StatesNew Approaches to Neuroblastoma Therapy Consortium

A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma

NCT06172296·Phase 3·BDTX
Recruiting

Primary endpoint: Event free survival (EFS)

InterventionalRandomizedopen478 targetStarted 2024-04Completion 2029-1250 sites · United StatesNational Cancer Institute (NCI)

A Phase 1b/2 Study of Abemaciclib in Combination With Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination With Temozolomide (Part B) in Pediatric and Young Adult Patients With Relapsed/Refractory Solid Tumors and Abemaciclib in Combination With Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients With Relapsed/Refractory Neuroblastoma (Part C)

NCT04238819·Phase 1/Phase 2·LLY
Completed

Primary endpoint: Recommended Phase 2 Dose (RP2D) of Abemaciclib in Combination With Irinotecan and Temozolomide (Part A)

Interventionalopen47 enrolledStarted 2020-11Completion 2025-0825 sites · Australia, Belgium, France, Germany…Eli Lilly and Company

A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab With or Without Eflornithine (DFMO) in Children With Relapsed, Refractory or Progressive Neuroblastoma

NCT03794349·Phase 2·BDTX
Active, not recruiting

Primary endpoint: Response Rate

InterventionalRandomizedopen94 targetStarted 2019-07Completion 2029-0350 sites · United StatesChildren's Oncology Group

A Phase I Dose Escalation Study of Autologous Expanded Natural Killer (NK) Cells for Immunotherapy of Relapsed Refractory Neuroblastoma With Dinutuximab +/- Lenalidomide

NCT02573896·Phase 1
Active, not recruiting

Primary endpoint: NK cell production feasibility (lowest dose level)

Interventionalopen13 targetStarted 2019-01Completion 2026-1211 sites · United StatesNew Approaches to Neuroblastoma Therapy Consortium

A Phase I Study of 131I-MIBG With Dinutuximab +/- Vorinostat for Relapsed/Refractory Neuroblastoma

NCT03332667·Phase 1·UTHR
Completed

Primary endpoint: MTD/RP2D Determination Cohort A

Interventionalopen45 enrolledStarted 2018-09Completion 2024-0212 sites · United StatesNew Approaches to Neuroblastoma Therapy Consortium

A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL)

NCT03126916·Phase 3
Recruiting

Primary endpoint: Event free survival (EFS) (Arm A, B, D, and E)

InterventionalRandomizedopen750 targetStarted 2018-05Completion 2030-0950 sites · United StatesChildren's Oncology Group

Frequently asked questions

Who is developing dinutuximab?

dinutuximab is being developed by UNITED THERAPEUTICS Corp.

How many clinical trials involve dinutuximab?

BioSniper tracks 8 clinical trials involving dinutuximab.