Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Omburtamab I-131
131I-omburtamab · 2 trials · 5 indications
Progression free survival after RIT + WA-IMRT.
Using the Kaplan Meier method, estimate of event-free survival (EFS) of patients with relapsed medulloblastoma treated with the study regimen. EFS is defined as the interval of time between enrollment on the study and the minimum date of documentation of progressive disease, death due to any cause, subsequent malignancy or date of last follow-up.
Percentage of patients who met feasibility criteria of incorporating cRIT 131I-omburtamab treatment for patients with recurrent ependymoma. Patients who meet both of the following criteria will be counted as feasibility successes: 1) Administration of the first therapeutic dose of the antibody at the treating institution within 6 days of labeling. 2) Successful acquisition of all 3 SPECT scans during the Dosimetry Course prior to Radioimmunotherapy.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Participants with DSRCT who have undergone GTR of their abdominopelvic disease and who have no definitive radiological evidence of disease in liver or outside the abd/pelvis. Patients if deemed of likely benefit to the patient after completing IP RIT plus WAP-IMRT, or will be mandated if ANC is persistently \<500/ul despite use of G-CSF for \>1 week, or if patients experience life threatening febrile neutropenia. |
| Group B | EXPERIMENTAL | DSRCT patients who have macroscopic residual disease OR who have previously experienced progression of disease while on treatment but have subsequently had a GTR |
| Group C | EXPERIMENTAL | Participants with tumors other than DSRCT and will be enrolled onto an assessment arm to determine eligibility. Immunohistochemistry to assess B7H3 expression will be performed on frozen or paraffin embedded tissue using omburtamab (frozen tissue) or a commercially available anti-B7H3 antibody (if paraffin embedded). |
| Recurrent Medulloblastoma | EXPERIMENTAL | This arm aims to estimate event-free survival (EFS) and overall survival (OS) following therapy with irinotecan, temozolomide, bevacizumab, and compartmental (intraOmmaya) radioimmunotherapy (cRIT) 131I-omburtamab in patients with recurrent medulloblastoma. Patients with recurrent medulloblastoma will undergo surgery if feasible prior to study entry, followed by Induction Chemotherapy with irinotecan, temozolomide, and bevacizumab on study as per the Children's Oncology Group (COG) trial ACNS0821. Following 2 or 4 courses of chemotherapy and if radiographic disease status is stable or improved, patients will receive 2 therapeutic doses of 50 mCi cRIT 131I-omburtamab during Radioimmunotherapy. Following Radioimmunotherapy, patients may resume to Maintenance Chemotherapy with irinotecan, temozolomide, and bevacizumab for up to 12 total courses of chemotherapy or until disease progression, whichever occurs sooner. |
| Recurrent Ependymoma | EXPERIMENTAL | This is a feasibility cohort. The primary objective is to assess feasibility of incorporating cRIT 131I-omburtamab for patients with recurrent ependymoma and to assess dosimetry. Patients must have progressed after initial surgery, radiation therapy, or other therapies. Patients will undergo surgery (if feasible) prior to study entry with the goal of achieving stable or better disease. Tumor tissue (archived or new) will be tested for B7H3 prior to enrollment. If positive, patients will enroll on Stratum 2 and receive one dosimetry dose (2 mCi) of cRIT 131I-omburtamab with nuclear medicine scintigraphy using SPECT during the Dosimetry Course (14 days in length). Following the Dosimetry Course and within 2 weeks of the dosimetry dose, patients may continue to Radioimmunotherapy to receive 2 therapeutic doses (50 mCi) of cRIT 131I-omburtamab. |
| Name | Type | Description |
|---|---|---|
| 131 I-omburtamab | DRUG | Single dose of IP RIT administered through an IP catheter with 131 I-omburtamab at 80mCi/m2 |
| WAP-IMRT | RADIATION | Group A participants will receive WAP-IMRT approximately 2-4 weeks after completing IP RIT. A dose of 30 Gy will be delivered in 20 fractions of 1.5 Gy given once daily, 5 days per week over the course of approximately 4 weeks |
| Irinotecan | DRUG | Irinotecan is a semisynthetic water-soluble analog of camptothecin (a plant alkaloid isolated from Camptotheca acuminata). Irinotecan is available in single-dose amber glass vials in 40 mg (2 mL) and 100 mg (5 mL), 300 mg (15 mL), and 500 mg (25 mL). Patients on Stratum 1 will be given irinotecan at 50 mg/m2/day IV on Days 1 through 5 of each chemotherapy course. |
| Temozolomide | DRUG | An orally administered alkylating agent, a second generation imidazotetrazine. A prodrug of MTIC, temozolomide spontaneously decomposes to MTIC at physiologic pH. Exerts its effect by cross-linking DNA. Temozolomide capsules are available in six different strengths (5, 20, 100, 140, 180, 250 mg). The capsules vary in size, color, and imprint according to strength. In the US, capsules are packaged in 5-count and 14-count bottles. Patients on Stratum 1 will be given temozolomide at 150 mg/m2/dose PO on Days 1-5 of each chemotherapy course. |
| Bevacizumab | DRUG | Bevacizumab is a recombinant humanized anti-vascular endothelial growth factor (anti-VEGF) monoclonal antibody. Bevacizumab is supplied as a clear to slightly opalescent, sterile liquid ready for parenteral administration. Each 400 mg (25 mg/mL, 16 mL fill) glass vial contains bevacizumab with phosphate, trehalose, polysorbate 20, and Sterile Water for Injection. Patients on Stratum 1 will be given bevacizumab at 10 mg/kg/day IV on Days 1 and 15 of each chemotherapy course, with the exception of the last course of Induction Chemotherapy (i.e., Course 2 or 4) where it will be administered on Day 1 only. |
| Omburtamab I-131 | DRUG | Omburtamab is a murine IgG1 monoclonal antibody (mAb) against B7-H3 (CD276) manufactured by in vivo growth of the hybridoma cell line without the use of animal-derived components. Omburtamab will be radiolabeled with iodine-131 at a designated radiolabeling facility. 131I-omburtamab is supplied as a sterile, injectable, radioactive product in a vial. Each supplied vial will contain enough radioactivity to prepare 50 mCi of 131I-omburtamab, formulated in 3.5-4 mL of solution. 131I-omburtamab should be administered via an intraventricular access device (i.e., Ommaya catheter or programmable VP shunt). Radioimmunotherapy consists of 56 days. Patients on Stratum 1 will receive a therapeutic dose of 50 mCi cRIT 131I-omburtamab on Days 8 and 36 of Radioimmunotherapy. Patients on Stratum 2 will receive a therapeutic dose of 50 mCi cRIT 131I-omburtamab on Days 1 and 29 of Radioimmunotherapy. |
| Liothyronine | DRUG | Liothyronine (or equivalent) will be given as premedication for 131I-omburtamab to prevent thyroid accumulation. Liothyronine (or equivalent) will be administered at 25 µg PO, NG, or G-tube (if weight \< 25 kg) or 50 µg PO, NG, or G-tube (if weight ≥ 25 kg) daily starting on Day 1 of Radioimmunotherapy (for Stratum 1 patients) or Day 1 of Dosimetry (for Stratum 2 patients), with a mandated minimum of 7 days before each 131I-omburtamab injection and 14 days after each 131I-omburtamab injection. On the day of the 131I-omburtamab injection, administer any time before the injection. |
| SSKI | DRUG | SSKI (potassium iodide) will be given as premedication for 131I-omburtamab to prevent thyroid accumulation. SSKI (potassium iodide) will be administered as 7 drops (\~0.35 mL) PO, NG, or G-tube daily starting on Day 1 of Radioimmunotherapy (for Stratum 1 patients) or Day 1 of Dosimetry (for Stratum 2 patients), with a mandated minimum of 7 days before each 131I-omburtamab injection and 14 days after each 131I-omburtamab injection. On the day of the 131I-omburtamab injection, administer any time before the injection. |
| Dexamethasone | DRUG | Dexamethasone will be given as premedication for 131I-omburtamab to prevent possible meningeal inflammatory reaction. Starting within 24 hours prior to each 131I-omburtamab injection, dexamethasone will be administered orally at 0.5 mg (if weight \< 15 kg) or 1 mg (if weight ≥ 15 kg) twice-daily doses for a total of 6 doses to alleviate infusion-related AEs: Two doses starting 24 hours pre-131I-omburtamab injection, two doses on the day of the injection (can be given before or after), and two doses 24 hours post-131I-omburtamab injection. |
| Antipyretic | DRUG | An antipyretic (e.g., oral acetaminophen \[15 mg/kg, 650 mg maximum\] or equivalent) will be given as premedication for 131I-omburtamab within 1 to 3 hours before each 131I-omburtamab injection. |
| Antihistamine | DRUG | An antihistamine (e.g., IV diphenhydramine \[1 mg/kg, 50 mg maximum\] or equivalent) will be given as premedication for 131I-omburtamab within 1 to 3 hours before each 131I-omburtamab injection. |
| anti-emetics | DRUG | An anti-emetic (e.g., IV ondansetron \[0.25 mg/kg, 16 mg maximum\] or equivalent) will be given as premedication for 131I-omburtamab within 1 to 3 hours before each 131I-omburtamab injection. |
Inclusion Criteria: * Have the diagnosis of DSRCT confirmed at MSKCC * Age \>1 year and able to cooperate with radiation safety restrictions during therapy period. * Prior to intraperitoneal catheter placement * At least 1 weeks must have elapsed since prior chemotherapy * At least 2 weeks mus...
131I-omburtamab is an investigational monoclonal antibody therapy being developed for certain pediatric and solid tumors. It is a radiolabeled antibody, meaning it combines a monoclonal antibody with radioactive iodine-131. Y-mAbs Therapeutics is studying it in Phase 2 clinical trials for desmoplastic small round cell tumor and recurrent medulloblastoma.
131I-omburtamab is being studied for desmoplastic small round cell tumor and recurrent medulloblastoma, and it has also been evaluated in peritoneal cancers. It is an investigational agent and is not approved for commercial use. Clinical testing is focused on oncology indications, particularly tumors that express the GD2 target.
131I-omburtamab targets GD2, a disialoganglioside antigen expressed on the surface of certain tumor cells. The monoclonal antibody component binds GD2, and the attached iodine-131 delivers localized radiation to targeted cells. This dual mechanism is designed to concentrate radiation at tumor sites while limiting exposure to surrounding healthy tissue.
Y-mAbs Therapeutics, Inc., which trades on Nasdaq under the ticker YMAB, is the developer of 131I-omburtamab. The company is conducting Phase 2 clinical development of the radiolabeled monoclonal antibody across oncology indications including desmoplastic small round cell tumor and recurrent medulloblastoma.
131I-omburtamab is in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA. Y-mAbs Therapeutics is evaluating it in active Phase 2 studies that are no longer recruiting participants, with a combined enrollment of 62 patients across the reported trials.
131I-omburtamab has been studied in two Phase 2 trials. NCT04743661 evaluates it in recurrent medulloblastoma and ependymoma, and NCT04022213 evaluates it in desmoplastic small round cell tumor and other peritoneal solid tumors. Both trials are active but not recruiting, and both are conducted in the United States.
Yes. 131I-omburtamab is also known as omburtamab I-131 and 131 I-omburtamab. These names refer to the same radiolabeled monoclonal antibody developed by Y-mAbs Therapeutics, so searches using any of these variations point to the same investigational oncology asset.