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    DRUG CLASS:

    GD2 ganglioside inhibitor

    Related drugs:
    8d
    GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2 (clinicaltrials.gov)
    P1, N=23, Terminated, Y-mAbs Therapeutics | N=60 --> 23 | Trial completion date: Apr 2027 --> Mar 2026 | Recruiting --> Terminated | Trial primary completion date: Mar 2027 --> Mar 2026; Decision by Sponsor
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
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    GD2-SADA
    11d
    Study 201: Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow (clinicaltrials.gov)
    P2, N=122, Active, not recruiting, Y-mAbs Therapeutics | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Danyelza (naxitamab-gqgk)
    22d
    Phase II Study of Chidamide-Dinutuximab Beta-Irinotecan-Temozolomide for Refractory/Relapsed Neuroblastoma in Children (clinicaltrials.gov)
    P2, N=27, Recruiting, Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    temozolomide • irinotecan • Epidaza (chidamide) • Qarziba (dinutuximab beta)
    23d
    Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral β-glucan for High-Risk Neuroblastoma (clinicaltrials.gov)
    P1/2, N=374, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: May 2026 --> May 2027 | Trial primary completion date: May 2026 --> May 2027
    Trial completion date • Trial primary completion date
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    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
    |
    MYCN amplification
    |
    GD2-GD3 Vaccine
    23d
    A534260: IT-hu14.18-IL2 With Radiation, Nivolumab and Ipilimumab for Melanoma (clinicaltrials.gov)
    P1/2, N=8, Terminated, University of Wisconsin, Madison | Trial completion date: Aug 2026 --> Dec 2025 | Active, not recruiting --> Terminated; Administrative
    Trial completion date • Trial termination
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    Opdivo (nivolumab) • Yervoy (ipilimumab) • lorukafusp alfa (APN301)
    24d
    NCI-2018-03732: Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov)
    P2, N=42, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: Sep 2026 --> Mar 2026
    Trial completion • Trial completion date
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    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    cisplatin • carboplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim) • dexrazoxane
    2ms
    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
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • Qarziba (dinutuximab beta) • Azedra (iobenguane I 131)
    2ms
    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
    |
    temozolomide • irinotecan • daretabart (hu1418K322A)
    2ms
    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
    |
    CD8 (cluster of differentiation 8) • ERBB4 (erb-b2 receptor tyrosine kinase 4) • GZMB (Granzyme B) • NRG3 (Neuregulin 3) • GNLY (Granulysin)
    |
    Danyelza (naxitamab-gqgk)
    2ms
    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
    |
    ALK (Anaplastic lymphoma kinase) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • CSF2 (Colony stimulating factor 2)
    |
    ALK mutation • MYCN amplification
    |
    Danyelza (naxitamab-gqgk)
    2ms
    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)
    2ms
    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)