Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
131 I-omburtamab · 1 trial · 3 indications
Progression free survival after RIT + WA-IMRT.
| 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). |
| 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 |
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...
131 I-omburtamab is an investigational drug being studied for the treatment of desmoplastic small round cell tumor, a rare type of cancer that often affects the peritoneum. It is also being evaluated for other solid tumors in the peritoneum. The drug is currently in Phase 2 clinical development.
131 I-omburtamab is being developed by Y-mAbs Therapeutics, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol YMAB. The drug is currently in Phase 2 clinical trials for desmoplastic small round cell tumor.
131 I-omburtamab is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is active but not recruiting participants, and it is studying the drug in patients with desmoplastic small round cell tumor and other solid tumors in the peritoneum.
131 I-omburtamab is being studied in a Phase 2 clinical trial with the identifier NCT04022213. The trial is titled "A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum." The trial is active but not recruiting, with an enrollment of 31 participants in the United States.
Yes, 131 I-omburtamab and I131-omburtamab refer to the same drug. The clinical trial NCT04022213 uses the name I131-omburtamab in its title. The drug is being developed by Y-mAbs Therapeutics for desmoplastic small round cell tumor and other peritoneal solid tumors.