^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    Omblastys (131I-omburtamab)

    i
    Other names: 131 I-8H9, 131I-8H9, 8H9 mAb, 131I 8H9 (B7-H3), Iodine I 131 MOAB 8H9
    Associations

    News

    Trials
    Company:
    Memorial Sloan-Kettering Cancer Center, SERB Pharmaceuticals, United Therapeutics Corp
    Drug class:
    Beta radiation emitter, B7-H3 inhibitor
    Related drugs:
    Associations

    News

    Trials
    4ms
    A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum (clinicaltrials.gov)
    P2, N=31, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jul 2025 --> Jul 2026 | Trial primary completion date: Jul 2025 --> Jul 2026
    Trial completion date • Trial primary completion date
    |
    Omblastys (131I-omburtamab)
    7ms
    A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum (clinicaltrials.gov)
    P2, N=31, Active, not recruiting, Memorial Sloan Kettering Cancer Center | N=55 --> 31 | Recruiting --> Active, not recruiting
    Enrollment closed • Enrollment change
    |
    Omblastys (131I-omburtamab)
    over1year
    A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum (clinicaltrials.gov)
    P2, N=55, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
    Trial completion date • Trial primary completion date
    |
    Omblastys (131I-omburtamab)
    almost2years
    Trial 101: 131I-omburtamab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases (clinicaltrials.gov)
    P2/3, N=52, Terminated, Y-mAbs Therapeutics | Trial completion date: Dec 2026 --> Jun 2023 | Active, not recruiting --> Terminated | Trial primary completion date: May 2026 --> Jun 2023; Corporate business decision. Not due to safety or efficacy concerns.
    Trial completion date • Trial termination • Trial primary completion date
    |
    Omblastys (131I-omburtamab)
    almost2years
    B7-H3 Inhibitors in Oncology Clinical Trials: A Review. (PubMed, J Immunother Precis Oncol)
    Particularly promising treatments are enoblituzumab for prostate cancer, 131I-omburtamab for central nervous system malignancies, and HS-20093 for small-cell lung cancer but further studies are warranted. These data will be telling of the efficacy of B7-H3 inhibitors in both hematologic and solid malignancies. This study aimed to compile available results of B7-H3 inhibitors in oncology clinical trials.
    Review • Journal
    |
    CD276 (CD276 Molecule)
    |
    GSK5764227 • Omblastys (131I-omburtamab) • enoblituzumab (MGA271)
    almost2years
    Laser interstitial thermal therapy as a radiation-sparing approach for central nervous system tumors in children with cancer predisposition syndromes: report of a child with Li-Fraumeni syndrome. Illustrative case. (PubMed, J Neurosurg Case Lessons)
    Alternatives to mutagenic therapies for brain tumors should be explored for patients with CPS. LITT paired with imaging surveillance is a logical strategy to ensure durable outcomes and mitigate treatment-related secondary neoplasms.
    Journal • IO biomarker
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    Omblastys (131I-omburtamab)
    almost2years
    131I-Omburtamab, in Recurrent Medulloblastoma and Ependymoma (clinicaltrials.gov)
    P2, N=62, Active, not recruiting, Pediatric Brain Tumor Consortium | Trial completion date: Oct 2029 --> Oct 2030 | Trial primary completion date: Oct 2028 --> Oct 2029
    Trial completion date • Trial primary completion date
    |
    CD276 (CD276 Molecule)
    |
    Avastin (bevacizumab) • temozolomide • irinotecan • Omblastys (131I-omburtamab) • dexamethasone injection • ondansetron intravenous
    almost2years
    Radiolabeled MAB Therapy in Patients With Refractory, Recurrent, or Advanced CNS or Leptomeningeal Cancer (clinicaltrials.gov)
    P1, N=177, Terminated, Y-mAbs Therapeutics | N=120 --> 177 | Active, not recruiting --> Terminated; Corporate business decision. No safety or efficacy concerns.
    Enrollment change • Trial termination • Metastases
    |
    Rituxan (rituximab) • Omblastys (131I-omburtamab)
    2years
    Intraperitoneal RIT With 131I-8H9 for Pts With DSRCT and Other Solid Tumors Involving the Peritoneum (clinicaltrials.gov)
    P1, N=54, Terminated, Y-mAbs Therapeutics | Active, not recruiting --> Terminated; Corporate business decision. Not due to safety or efficacy concerns
    Trial termination
    |
    CD34 (CD34 molecule)
    |
    Omblastys (131I-omburtamab)
    over2years
    131I-omburtamab Delivered by Convection-Enhanced Delivery in Patients With Diffuse Intrinsic Pontine Glioma (clinicaltrials.gov)
    P1, N=0, Withdrawn, Y-mAbs Therapeutics | N=36 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    Omblastys (131I-omburtamab)
    over2years
    Intraperitoneal Radioimmunotherapy With 131I-8H9 for Patients With Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum (clinicaltrials.gov)
    P1, N=54, Active, not recruiting, Y-mAbs Therapeutics | Trial completion date: Sep 2022 --> Sep 2023
    Trial completion date
    |
    CD34 (CD34 molecule)
    |
    Omblastys (131I-omburtamab)
    almost3years
    131I-Omburtamab, in Recurrent Medulloblastoma and Ependymoma (clinicaltrials.gov)
    P2, N=62, Active, not recruiting, Pediatric Brain Tumor Consortium | Trial completion date: Jul 2030 --> Oct 2029 | Trial primary completion date: Jul 2027 --> Oct 2028
    Trial completion date • Trial primary completion date
    |
    CD276 (CD276 Molecule)
    |
    Avastin (bevacizumab) • temozolomide • irinotecan • Omblastys (131I-omburtamab) • dexamethasone injection • ondansetron intravenous