Naxitamab

DRUG9 trials

Conditions

Anatomic Stage IV Breast Cancer AJCC v8Ewing SarcomaHER2-Negative Breast CarcinomaMetastatic Triple-Negative Breast CancerNeuroblastomaNeuroblastoma RecurrentRefractory NeuroblastomaRelapsed Neuroblastoma

Phase 1

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

RecruitingNCT06026657

Margaret Gatti-MaysAnatomic Stage IV Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma

Start: 2024-04-02End: 2026-12-31Target: 42Updated: 2025-07-08

Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)

RecruitingNCT07011654

M.D. Anderson Cancer CenterMetastatic Triple-Negative Breast Cancer

Start: 2025-09-19End: 2030-07-01Target: 31Updated: 2025-10-23

Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma

RecruitingNCT07027748

Steven DuBois, MDNeuroblastoma, Neuroblastoma Recurrent, Refractory Neuroblastoma +1

Start: 2025-06-27End: 2027-12-01Target: 18Updated: 2025-07-14

Phase 2

Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.

WithdrawnNCT04909515

Y-mAbs TherapeuticsNeuroblastoma

Start: 2021-12-02End: 2027-04-30Updated: 2022-09-01

Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma

RecruitingNCT05489887

Giselle ShollerNeuroblastoma

Start: 2022-09-14End: 2036-09-01Target: 93Updated: 2026-02-03

Quadruple Immunotherapy for Neuroblastoma

RecruitingNCT05754684

Hong Kong Children's HospitalNeuroblastoma Recurrent

Start: 2022-01-01End: 2025-12-31Target: 29Updated: 2025-09-15

To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Butterfly)

RecruitingNCT05968768

Anna RaciborskaEwing Sarcoma

Start: 2023-10-24End: 2028-07-31Target: 24Updated: 2025-04-10

Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma

RecruitingNCT06540963

Giselle ShollerNeuroblastoma

Start: 2024-12-06End: 2035-12-01Target: 98Updated: 2026-03-02

Phase 4

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.

Not yet recruitingNCT06047535

SciClone PharmaceuticalsNeuroblastoma

Start: 2023-10-31End: 2027-08-15Target: 62Updated: 2023-09-21

Related Papers

Abstract P3-12-29: Phase 1b/2 Study of Naxitamab (Danyelza), Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) cells in Advanced GD2-expressing Breast Cancers (DiG NKs)