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    DRUG CLASS:

    GD2 ganglioside inhibitor

    Related drugs:
    14d
    Inbraced: Phase I Study of 131-I mIBG Followed by Nivolumab & Dinutuximab Beta Antibodies in Children With Relapsed/Refractory Neuroblastoma (clinicaltrials.gov)
    P1, N=44, Active, not recruiting, University Hospital Southampton NHS Foundation Trust | Trial completion date: Nov 2025 --> Sep 2026
    Trial completion date
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    PD-L1 expression
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    Opdivo (nivolumab) • Qarziba (dinutuximab beta) • Azedra (iobenguane I 131)
    18d
    SHINE: A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients (clinicaltrials.gov)
    P2/3, N=144, Recruiting, Renaissance Pharma Ltd.
    New P2/3 trial
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    temozolomide • irinotecan • daretabart (hu1418K322A)
    20d
    Single-cell transcriptomic atlas-guided NRG3-ERBB4 axis enhances the efficacy of chemo-immunotherapy during induction phase in high-risk neuroblastoma. (PubMed, Mol Ther)
    Collectively, these findings delineate an NRG3-ERBB4 axis-centered tumor-immune crosstalk that operates across pretreatment, chemotherapy, and CI, uncovering a previously unrecognized mechanism underlying naxitamab-mediated immune activation. Our results also support ERBB4 as a promising predictive biomarker and therapeutic target to optimize CI strategies for high-risk NB.
    Journal • IO biomarker
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    CD8 (cluster of differentiation 8) • ERBB4 (erb-b2 receptor tyrosine kinase 4) • GZMB (Granzyme B) • NRG3 (Neuregulin 3) • GNLY (Granulysin)
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    Danyelza (naxitamab-gqgk)
    25d
    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 (clinicaltrials.gov)
    P2, N=10, Not yet recruiting, Shaare Zedek Medical Center
    New P2 trial
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    ALK (Anaplastic lymphoma kinase) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • CSF2 (Colony stimulating factor 2)
    |
    ALK mutation • MYCN amplification
    |
    Danyelza (naxitamab-gqgk)
    26d
    Therapy for Children With Advanced Stage Neuroblastoma (clinicaltrials.gov)
    P2, N=153, Completed, St. Jude Children's Research Hospital | Active, not recruiting --> Completed
    Trial completion
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    cisplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • topotecan • melphalan • mesna • Proleukin (aldesleukin) • busulfan • Unituxin (dinutuximab) • Leukine (sargramostim) • Neupogen (filgrastim) • daretabart (hu1418K322A)
    27d
    Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse (clinicaltrials.gov)
    P1/2, N=76, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: May 2026 --> Jul 2026
    Trial initiation date
    |
    cyclophosphamide • topotecan • Qarziba (dinutuximab beta) • iberdomide (CC-220) • Unituxin (dinutuximab) • Leukine (sargramostim)
    1m
    Concurrent naxitamab and lorlatinib in a patient with refractory high-risk neuroblastoma: a case report. (PubMed, Front Oncol)
    Mild adverse events occurred during the combined immunotherapy, including transient hypotension managed with intravenous fluids and abdominal and leg pain that improved with analgesics. In conclusion, our case showed that combination therapy with naxitamab and lorlatinib may improve long-term outcomes and reduce chemotherapy-related toxicity.
    Journal • IO biomarker
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    ALK (Anaplastic lymphoma kinase)
    |
    ALK mutation
    |
    oncoReveal™ Multi-Cancer with CNV & RNA Fusion Panel
    |
    Lorbrena (lorlatinib) • Danyelza (naxitamab-gqgk)
    1m
    Role of Anti-GD2 Targeted PEG-b-PLGA Nanoparticles in the Treatment of MYCN Driven Neuroblastoma. (PubMed, ACS Appl Bio Mater)
    Everolimus (EVER) and tozasertib (TOZA) encapsulated in NP and targeted with dinutuximab β (DTX-β). DTX-β/EVER-TOZA@PEG-b-PLGA may exert cytotoxic and apoptotic effects in NB. The use of targeted nanocarriers in NB treatment may enhance cytotoxic and apoptotic responses specifically in the tumor region.
    Journal
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN expression
    |
    everolimus • Unituxin (dinutuximab) • tozasertib (MK-0457)
    2ms
    End-of-Induction Response and Tolerability of High-Risk Neuroblastoma Treated with Chemoimmunotherapy-Modified N7 Regimen with Dinutuximab Beta. (PubMed, Cancers (Basel))
    The incorporation of dinutuximab beta into a modified N7 induction regimen demonstrates a satisfactory EOI response rate and a manageable safety profile in children with HR-NB. These preliminary results support the feasibility of this chemoimmunotherapy approach and warrant further investigation in larger cohorts to confirm its efficacy in long-term survival outcomes.
    Journal
    |
    CSF2 (Colony stimulating factor 2)
    |
    Qarziba (dinutuximab beta)
    2ms
    NANT 2013-01: Immunotherapy of Relapsed Refractory Neuroblastoma With Expanded NK Cells (clinicaltrials.gov)
    P1, N=13, Active, not recruiting, New Approaches to Neuroblastoma Therapy Consortium | Trial completion date: Sep 2025 --> Dec 2026 | Trial primary completion date: Sep 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    lenalidomide • Unituxin (dinutuximab)
    2ms
    NANT: Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma (clinicaltrials.gov)
    P1, N=27, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2026 --> Mar 2027
    Trial completion date
    |
    lenalidomide • Qarziba (dinutuximab beta) • Unituxin (dinutuximab)
    2ms
    Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma (clinicaltrials.gov)
    P3, N=1449, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed
    Trial completion
    |
    Proleukin (aldesleukin) • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)