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25 mCi 177Lu- DTPA-omburtamab · 1 trial · 4 indications
To determine safety of up to 2 cycles of cRIT with 177Lu-DTPA-omburtamab treatment in pediatric patients graded according to CTCAE version 5
To determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of a single injection of cRIT with 177Lu-DTPA-omburtamab in pediatric patients.
| Arm | Type | Description |
|---|---|---|
| Dose Level 1: 25 mCi | EXPERIMENTAL | 25 mCi 177Lu- DTPA-omburtamab |
| Dose Level 2: 50 mCi | EXPERIMENTAL | 50 mCi 177Lu- DTPA-omburtamab |
| Dose Level 3: 75 mCi | EXPERIMENTAL | 75 mCi 177Lu- DTPA-omburtamab |
| Dose Level 4: 100 mCi | EXPERIMENTAL | 100 mCi 177Lu- DTPA-omburtamab |
| Name | Type | Description |
|---|---|---|
| 25 mCi 177Lu- DTPA-omburtamab | BIOLOGICAL | The dose of DTPA-omburtamab will be decided by the dose escalation design |
Inclusion Criteria: \- Disease type: * Histologically confirmed diagnosis of a tumor that is known to express B7-H3 including but not limited to neuroblastoma, medulloblastoma, rhabdoid tumors, pineoblastoma, retinoblastoma, CNS embryonal tumor, rhabdomyosarcoma, Ewing's sarcoma and ependymoma. ...
25 mCi 177Lu-DTPA-omburtamab is an investigational monoclonal antibody being studied for the treatment of recurrent medulloblastoma, a type of brain cancer, in children and adolescents. It is also being evaluated for cancer that has spread to the central nervous system, including refractory medulloblastoma and CNS metastases.
25 mCi 177Lu-DTPA-omburtamab is a radiolabeled monoclonal antibody that delivers the radioactive isotope lutetium-177 to cancer cells. It is designed to bind to a target on tumor cells, allowing targeted delivery of radiation to treat recurrent medulloblastoma and CNS metastases.
25 mCi 177Lu-DTPA-omburtamab is being developed by Y-mAbs Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol YMAB. The company is conducting clinical trials to evaluate the drug in pediatric patients with brain cancer.
25 mCi 177Lu-DTPA-omburtamab is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is recruiting patients to evaluate the safety and dosing of the drug in children and adolescents.
25 mCi 177Lu-DTPA-omburtamab is being studied in a Phase 1 clinical trial registered as NCT07698899. The trial, titled 'A Study of 177Lu-DTPA-Omburtamab in Children and Adolescents With Brain Cancer or Cancer That Has Spread to the Central Nervous System,' is recruiting 18 participants in the United States.
25 mCi 177Lu-DTPA-omburtamab is a radiolabeled form of omburtamab, where the antibody is conjugated to the radioactive isotope lutetium-177. This formulation is being studied specifically for delivering targeted radiation to recurrent medulloblastoma and CNS metastases in pediatric patients.