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Omblastys (131I-omburtamab)
i
Other names: 131 I-8H9, 131I-8H9, 8H9 mAb, 131I 8H9 (B7-H3), Iodine I 131 MOAB 8H9
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News alerts, weekly reports and conference planners
Company:
Memorial Sloan-Kettering Cancer Center, United Therapeutics Corp, Y-mAbs Therap
Drug class:
B7-H3 inhibitor
Related drugs:
3ms
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)
9ms
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
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Omblastys (131I-omburtamab)
9ms
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
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CD276 (CD276 Molecule)
|
GSK5764227 • Omblastys (131I-omburtamab) • enoblituzumab (MGA271)
9ms
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
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TP53 (Tumor protein P53)
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TP53 mutation
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Omblastys (131I-omburtamab)
10ms
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
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CD276 (CD276 Molecule)
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Avastin (bevacizumab) • temozolomide • irinotecan • Omblastys (131I-omburtamab) • dexamethasone injection • ondansetron intravenous
11ms
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
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Rituxan (rituximab) • Omblastys (131I-omburtamab)
1year
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)
over1year
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)
over1year
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)
almost2years
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
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CD276 (CD276 Molecule)
|
Avastin (bevacizumab) • temozolomide • irinotecan • Omblastys (131I-omburtamab) • dexamethasone injection • ondansetron intravenous
over2years
PHASE 1 STUDY OF INTRAVENTRICULAR 131I-OMBURTAMAB TARGETING B7H3 (CD276)-EXPRESSING CNS MALIGNANCIES (SIOP 2022)
In patients developing anti-drug antibodies (38%), blood clearance, and therefore therapeutic index was significantly increased. In patients receiving cRIT for neuroblastoma, survival was markedly increased (median PFS 7.5 years) compared to historical data.ConclusionscRIT with 131I-omburtamab is safe, has favorable dosimetry and may have a therapeutic benefit as adjuvant therapy for B7-H3-expressing leptomeningeal metastases.
P1 data • IO biomarker
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CD276 (CD276 Molecule)
|
CD276 expression
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Omblastys (131I-omburtamab)
over2years
131I-Omburtamab, in Recurrent Medulloblastoma and Ependymoma (clinicaltrials.gov)
P2, N=62, Recruiting, Pediatric Brain Tumor Consortium | Active, not recruiting --> Recruiting
Enrollment open
|
CD276 (CD276 Molecule)
|
Avastin (bevacizumab) • temozolomide • irinotecan • Omblastys (131I-omburtamab) • dexamethasone injection • ondansetron intravenous
almost3years
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 2021 --> Sep 2022
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 | Recruiting --> Active, not recruiting
Enrollment closed
|
CD276 (CD276 Molecule)
|
Avastin (bevacizumab) • temozolomide • irinotecan • Omblastys (131I-omburtamab) • dexamethasone injection • ondansetron intravenous
almost3years
131I-Omburtamab, in Recurrent Medulloblastoma and Ependymoma (clinicaltrials.gov)
P2, N=62, Recruiting, Pediatric Brain Tumor Consortium | Not yet recruiting --> Recruiting
Clinical • Enrollment open
|
CD276 (CD276 Molecule)
|
Avastin (bevacizumab) • temozolomide • irinotecan • Omblastys (131I-omburtamab) • dexamethasone injection • ondansetron intravenous
3years
131I-omburtamab for the Treatment of Central Nervous System/Leptomeningeal Neoplasms in Children and Young Adults (clinicaltrials.gov)
P=N/A, Available, Memorial Sloan Kettering Cancer Center
Clinical • New trial
|
CD276 (CD276 Molecule)
|
Omblastys (131I-omburtamab)
3years
131I-Omburtamab, in Recurrent Medulloblastoma and Ependymoma (clinicaltrials.gov)
P2, N=62, Not yet recruiting, Pediatric Brain Tumor Consortium | Initiation date: Apr 2021 --> Oct 2021
Clinical • Trial initiation date
|
CD276 (CD276 Molecule)
|
Avastin (bevacizumab) • temozolomide • irinotecan • Omblastys (131I-omburtamab) • dexamethasone injection • ondansetron intravenous
over3years
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 2020 --> Sep 2021
Clinical • Trial completion date
|
CD34 (CD34 molecule)
|
Omblastys (131I-omburtamab)
almost4years
131I-Omburtamab, in Recurrent Medulloblastoma and Ependymoma (clinicaltrials.gov)
P2, N=62, Not yet recruiting, Pediatric Brain Tumor Consortium
Clinical • New P2 trial
|
CD276 (CD276 Molecule)
|
Avastin (bevacizumab) • temozolomide • irinotecan • Omblastys (131I-omburtamab)
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