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    DRUG CLASS:

    GD2 ganglioside inhibitor

    Related drugs:
    13d
    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 | Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2024 --> May 2025
    Enrollment closed • Trial primary completion date
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • Qarziba (dinutuximab beta) • Azedra (iobenguane I 131)
    19d
    PET Imaging of Solid Tumors Using 124I-Humanized 3F8: A Pilot Study (clinicaltrials.gov)
    P=N/A, N=7, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
    Trial completion date • Trial primary completion date
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    Danyelza (naxitamab-gqgk)
    23d
    Iwilfin (eflornithine) approved by the FDA as the first and only oral maintenance therapy for high-risk neuroblastoma in adult and pediatric patients: Narrative review. (PubMed, Medicine (Baltimore))
    While dinutuximab beta immunotherapy is an effective and widely used treatment, it has several potential side effects that must be carefully monitored...However, DFMO has adverse effects that require continuous monitoring. Further research is needed to minimize these side effects and improve its efficacy, particularly in addressing resistance caused by long-term use.
    FDA event • Review • Journal • IO biomarker
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    Qarziba (dinutuximab beta)
    1m
    MIBG With Dinutuximab +/- Vorinostat (clinicaltrials.gov)
    P1, N=45, Active, not recruiting, New Approaches to Neuroblastoma Therapy Consortium | Trial primary completion date: Jun 2023 --> Feb 2024
    Trial primary completion date
    |
    CD34 (CD34 molecule)
    |
    Zolinza (vorinostat) • Unituxin (dinutuximab) • Azedra (iobenguane I 131) • Leukine (sargramostim)
    1m
    GINAKIT2: GD2 Specific CAR and Interleukin-15 Expressing Autologous NKT Cells to Treat Children with Neuroblastoma (clinicaltrials.gov)
    P1, N=54, Recruiting, Baylor College of Medicine | N=36 --> 54
    Enrollment change
    |
    KUR-501
    2ms
    NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial (clinicaltrials.gov)
    P2, N=62, Recruiting, New Approaches to Neuroblastoma Therapy Consortium | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    temozolomide • irinotecan • Unituxin (dinutuximab) • Leukine (sargramostim)
    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 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
    Trial completion date • Trial primary completion date
    |
    lenalidomide • Unituxin (dinutuximab)
    2ms
    Rapid Administration Pilot for Infusing Dinutuximab (clinicaltrials.gov)
    P4, N=11, Suspended, Children's Hospital Los Angeles | Trial completion date: Aug 2024 --> Jun 2025 | Recruiting --> Suspended | Trial primary completion date: Aug 2024 --> Jun 2025
    Trial completion date • Trial suspension • Trial primary completion date
    |
    temozolomide • cyclophosphamide • irinotecan • topotecan • Unituxin (dinutuximab)
    2ms
    FollowTheDIN: Chemo-immunotherapy in Patients Under 18 Years of Age With Bone and Soft Tissue Sarcomas (clinicaltrials.gov)
    P3, N=40, Recruiting, N.N. Petrov National Medical Research Center of Oncology
    New P3 trial
    |
    carboplatin • docetaxel • temozolomide • doxorubicin hydrochloride • irinotecan • Qarziba (dinutuximab beta)
    2ms
    ANBL19P1: Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL) (clinicaltrials.gov)
    P2, N=41, Active, not recruiting, Children's Oncology Group | Trial completion date: Sep 2024 --> Sep 2025
    Trial completion date • Combination therapy
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
    2ms
    NCI-2018-03732: Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov)
    P2, N=42, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2024 --> Sep 2025
    Trial completion date
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • IL6 (Interleukin 6) • CXCL9 (Chemokine (C-X-C motif) ligand 9)
    |
    MYCN amplification • IL6 expression
    |
    cisplatin • carboplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim) • dexrazoxane
    2ms
    DiTuSarc: Treatment with Dinutuximab Beta, Zoledronic Acid and Low-dose Interleukin (IL-2) in Patients with Leiomyosarcoma (clinicaltrials.gov)
    P2, N=10, Active, not recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting --> Active, not recruiting | Trial completion date: Jul 2024 --> Jan 2025
    Enrollment closed • Trial completion date • Metastases
    |
    zoledronic acid • Qarziba (dinutuximab beta)
    3ms
    Downregulation of B4GALNT1 inhibits proliferation and metastasis of osteosarcoma cells. (PubMed, Zhong Nan Da Xue Xue Bao Yi Xue Ban)
    B4GALNT1 is upregulated in osteosarcoma tissues and cell lines, and its knockdown suppresses the malignant phenotype of osteosarcoma cells. B4GALNT1 may function as an oncogene in the proliferation and metastasis of osteosarcoma cells.
    Journal
    |
    VIM (Vimentin) • B4GALNT1 (Beta-1,4-N-Acetyl-Galactosaminyltransferase 1) • CDH2 (Cadherin 2) • MMP9 (Matrix metallopeptidase 9)
    |
    B4GALNT1 expression • VIM expression
    3ms
    A534260: IT-hu14.18-IL2 With Radiation, Nivolumab and Ipilimumab for Melanoma (clinicaltrials.gov)
    P1/2, N=61, Suspended, University of Wisconsin, Madison | Trial completion date: Aug 2025 --> Aug 2026 | Trial primary completion date: Aug 2024 --> Aug 2025
    Trial completion date • Trial primary completion date • IO biomarker • Metastases
    |
    IL2 (Interleukin 2)
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • lorukafusp alfa (APN301)
    3ms
    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, Recruiting, Y-mAbs Therapeutics | Trial primary completion date: May 2025 --> Apr 2026
    Trial primary completion date
    |
    Danyelza (naxitamab-gqgk)
    4ms
    MIBG With Dinutuximab +/- Vorinostat (clinicaltrials.gov)
    P1, N=45, Active, not recruiting, New Approaches to Neuroblastoma Therapy Consortium | Trial completion date: Jun 2024 --> Jun 2025
    Trial completion date
    |
    CD34 (CD34 molecule)
    |
    Zolinza (vorinostat) • Unituxin (dinutuximab) • Azedra (iobenguane I 131) • Leukine (sargramostim)
    4ms
    Adding Of Naxitamb In Induction Therapy For High Risk Neuroblastoma (clinicaltrials.gov)
    P=N/A, N=64, Recruiting, Guangzhou Women and Children's Medical Center
    New trial
    |
    Danyelza (naxitamab-gqgk)
    5ms
    N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma (clinicaltrials.gov)
    P2, N=45, Recruiting, Memorial Sloan Kettering Cancer Center
    New P2 trial
    |
    carboplatin • temozolomide • doxorubicin hydrochloride • cyclophosphamide • ifosfamide • etoposide IV • irinotecan • vincristine • topotecan • Danyelza (naxitamab-gqgk) • Leukine (sargramostim)
    6ms
    DBPilot: Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma (clinicaltrials.gov)
    P1, N=38, Not yet recruiting, Princess Maxima Center for Pediatric Oncology
    New P1 trial
    |
    Qarziba (dinutuximab beta)
    6ms
    Study of Chemoimmunotherapy for High-Risk Neuroblastoma (clinicaltrials.gov)
    P1, N=48, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Phase classification: P2 --> P1 | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
    Phase classification • Trial completion date • Trial primary completion date
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    temozolomide • irinotecan • Danyelza (naxitamab-gqgk) • Leukine (sargramostim)
    6ms
    A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma (clinicaltrials.gov)
    P2, N=59, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
    Trial completion date • Trial primary completion date
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    Danyelza (naxitamab-gqgk)
    6ms
    Long Prime-Boost Interval and Heightened Anti-GD2 Antibody Response to Carbohydrate Cancer Vaccine. (PubMed, Vaccines (Basel))
    The carbohydrate ganglioside GD2/GD3 cancer vaccine adjuvanted by β-glucan stimulates anti-GD2 IgG1 antibodies that strongly correlate with improved progression-free survival (PFS) and overall survival (OS) among patients with high-risk neuroblastoma...The association between IgG1 titer during re-enrollment and β-glucan receptor dectin-1 SNP rs3901533 was significant (p = 0.01). A longer prime-boost interval could significantly improve antibody responses in patients treated with ganglioside conjugate cancer vaccines.
    Journal
    |
    CLEC7A (C-Type Lectin Domain Containing 7A)
    |
    GD2-GD3 Vaccine
    6ms
    Patterns of recurrence after radiotherapy for high-risk neuroblastoma: Implications for radiation dose and field. (PubMed, Radiother Oncol)
    Despite EBRT, LRR remains a contributor to treatment failure in HR-NBL with approximately half of LRRs including a component of marginal failure. Future prospective studies are needed to explore whether radiation fields and doses should be defined based on molecular features such as MYCN amplification, and/or response to chemotherapy.
    Journal
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    Unituxin (dinutuximab)
    7ms
    Targeting both GD2 and B7-H3 using bispecific antibody improves tumor selectivity for GD2-positive tumors. (PubMed, bioRxiv)
    We assessed the avidity and selectivity of our GD2-B7-H3 targeting bispecific antibodies (INV34-6, INV33-2, and INV36-6) towards GD2 + /hB7-H3 - B78 cells relative to GD2 + /hB7-H3 + B78 cells using flow cytometry and competition binding assays, comparing results an anti-GD2 antibody (dinutuximab, DINU). The bispecific antibodies, DINU, and a non-targeted bispecific control (bsAb CTRL) were conjugated with deferoxamine for radiolabeling with Zr-89 (t 1/2 = 78.4 h)...This approach should address the severe toxicities associated with GD2-targeting therapies by reducing off-tumor GD2 binding in nerves. Continued improvements in bispecific antibody technologies will continue to transform the therapeutic biologics landscape.
    Journal
    |
    CD276 (CD276 Molecule)
    |
    Unituxin (dinutuximab)
    7ms
    NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial (clinicaltrials.gov)
    P2, N=62, Not yet recruiting, New Approaches to Neuroblastoma Therapy Consortium
    New P2 trial • Combination therapy
    |
    temozolomide • irinotecan • Unituxin (dinutuximab) • Leukine (sargramostim)
    7ms
    Enhancing IgA-mediated neutrophil cytotoxicity against neuroblastoma by CD47 blockade. (PubMed, J Immunother Cancer)
    These promising results highlight the potential to enhance immunotherapy efficacy against high-risk neuroblastoma through improved neutrophil cytotoxicity by combining IgA therapy with CD47 blockade.
    Journal
    |
    CD47 (CD47 Molecule) • SIRPA (Signal Regulatory Protein Alpha)
    |
    Unituxin (dinutuximab)
    7ms
    Transition to a mesenchymal state in neuroblastoma may be characterized by a high expression of GD2 and by the acquisition of immune escape from NK cells. (PubMed, Front Immunol)
    Concerning 691 and 717, they show high levels of GD2 and resistance to NK cell-mediated killing that can be overcome by the administration of dinutuximab beta, the anti-GD2 monoclonal antibody applied in the clinic. NB is a heterogeneous tumor representing a further hurdle in NB immunotherapy. However, different from what was reported with NB commercial cells and independent of their MES/ADRN phenotype, the expression of GD2 and its displayed sensitivity to anti-GD2 mAb ADCC indicated the possible effectiveness of anti-GD2 immunotherapy.
    Journal • IO biomarker
    |
    WWTR1 (WW Domain Containing Transcription Regulator 1) • ENG (Endoglin)
    |
    Qarziba (dinutuximab beta)
    8ms
    Evaluation of a Combinatorial Immunotherapy Regimen That Can Cure Mice Bearing MYCN-Driven High-Risk Neuroblastoma That Resists Current Clinical Therapy. (PubMed, J Clin Med)
    First, we demonstrate that 9464D-GD2 is nonresponsive to a preferred salvage regimen: anti-GD2 with temozolomide and irinotecan. Second, we have previously shown that adding agonist anti-CD40 mAb and CpG to a regimen of radiotherapy, anti-GD2/IL2 immunocytokine and anti-CTLA-4, cured a substantial fraction of mice bearing small 9464D-GD2 tumors; here, we further characterize this regimen by showing that radiotherapy and hu14.18-IL2 are necessary components, while anti-CTLA-4, anti-CD40, or CpG can individually be removed, and CpG and anti-CTLA-4 can be removed together, while maintaining efficacy. We have developed and characterized a regimen that can cure mice of a high-risk neuroblastoma that is refractory to the current clinical regimen for relapsed/refractory disease. Ongoing preclinical work is directed towards ways to potentially translate these findings to a regimen appropriate for clinical testing.
    Preclinical • Journal
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • IL2 (Interleukin 2)
    |
    MYCN amplification
    |
    temozolomide • irinotecan • lorukafusp alfa (APN301)
    8ms
    Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma (clinicaltrials.gov)
    P3, N=478, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
    Enrollment open • Surgery
    |
    ALK (Anaplastic lymphoma kinase) • TERT (Telomerase Reverse Transcriptase) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    cisplatin • carboplatin • temozolomide • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • irinotecan • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • dexrazoxane
    8ms
    Testing the Combination of Two Immunotherapy Drugs (Magrolimab and Dinutuximab) in Patients With Relapsed or Refractory Neuroblastoma or Relapsed Osteosarcoma (clinicaltrials.gov)
    P1, N=82, Active, not recruiting, National Cancer Institute (NCI) | Suspended --> Active, not recruiting
    Enrollment closed
    |
    magrolimab (ONO-7913) • Qarziba (dinutuximab beta) • Unituxin (dinutuximab)
    8ms
    Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma (clinicaltrials.gov)
    P3, N=1449, Active, not recruiting, National Cancer Institute (NCI)
    Trial completion date
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • NCR3LG1 (Natural Killer Cell Cytotoxicity Receptor 3 Ligand 1)
    |
    Proleukin (aldesleukin) • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
    8ms
    Safety Study of Dinutuximab Combined With Immunotherapy to Treat Neuroblastoma (clinicaltrials.gov)
    P2, N=24, Completed, Fundació Sant Joan de Déu | Unknown status --> Completed
    Trial completion
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    Unituxin (dinutuximab) • Leukine (sargramostim)
    8ms
    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, Recruiting, University Hospital Southampton NHS Foundation Trust | Trial completion date: Nov 2023 --> Jul 2025 | Trial primary completion date: Nov 2023 --> Sep 2024
    Trial completion date • Trial primary completion date
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • Qarziba (dinutuximab beta) • Azedra (iobenguane I 131)
    8ms
    NCI-2018-03732: Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov)
    P2, N=42, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Sep 2024
    Trial completion date
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • IL6 (Interleukin 6) • CXCL9 (Chemokine (C-X-C motif) ligand 9)
    |
    MYCN amplification • IL6 expression
    |
    cisplatin • carboplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim) • dexrazoxane
    8ms
    Choosing T-cell sources determines CAR-T cell activity in neuroblastoma. (PubMed, Front Immunol)
    Moreover, ex vivo culture with IL-7+IL-15+IL-21 could favor CAR-T products with a longer persistence in the host. Our strategy may complement the current use of Dinutuximab in treating NB through its combination with a targeted CAR-T cell approach.
    Journal • CAR T-Cell Therapy
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • IL2 (Interleukin 2) • IL15 (Interleukin 15) • IL21 (Interleukin 21) • IL7 (Interleukin 7)
    |
    Unituxin (dinutuximab)
    9ms
    Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma (clinicaltrials.gov)
    P2, N=46, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Danyelza (naxitamab-gqgk)
    9ms
    GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2 (clinicaltrials.gov)
    P1, N=60, Recruiting, Y-mAbs Therapeutics | Trial completion date: Jan 2025 --> Apr 2027 | Trial primary completion date: Mar 2024 --> Mar 2027
    Trial completion date • Trial primary completion date • Metastases
    |
    GD2-SADA
    10ms
    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
    |
    lenalidomide • Qarziba (dinutuximab beta) • Unituxin (dinutuximab)
    10ms
    Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma (clinicaltrials.gov)
    P2, N=95, Active, not recruiting, Children's Oncology Group | Trial completion date: Jun 2024 --> Mar 2025 | Trial primary completion date: Jun 2024 --> Mar 2025
    Trial completion date • Trial primary completion date
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • CD276 (CD276 Molecule) • TNFA (Tumor Necrosis Factor-Alpha)
    |
    temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
    10ms
    DNB: Dinutuximab Beta at the HUS and the Toulouse Oncopole (clinicaltrials.gov)
    P=N/A, N=40, Recruiting, University Hospital, Strasbourg, France
    New trial • HEOR
    |
    Qarziba (dinutuximab beta)
    10ms
    STING: NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab (clinicaltrials.gov)
    P1/2, N=31, Recruiting, Nationwide Children's Hospital | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial primary completion date • Combination therapy
    |
    temozolomide • irinotecan • Unituxin (dinutuximab) • Leukine (sargramostim)
    10ms
    Humanized Anti-GD2 Antibody Hu3F8 and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma (clinicaltrials.gov)
    P1, N=85, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
    Trial completion date • Trial primary completion date
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    cyclophosphamide • Danyelza (naxitamab-gqgk)