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Also known as 25 mCi 177Lu- DTPA-omburtamab
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. ...
177Lu-DTPA-omburtamab is an investigational monoclonal antibody-based radiopharmaceutical being studied in children and adolescents with brain cancer or cancer that has spread to the central nervous system. It is being developed by Y-mAbs Therapeutics, Inc. (ticker: YMAB) and is currently in Phase 1 clinical development.
177Lu-DTPA-omburtamab is being studied for recurrent medulloblastoma, as well as refractory medulloblastoma and central nervous system metastases. It is an investigational therapy in Phase 1 testing and has not been established as a treatment for these conditions. The research is enrolling children and adolescents aged 3 years and older.
177Lu-DTPA-omburtamab is being developed by Y-mAbs Therapeutics, Inc., which trades under the ticker YMAB. The company is sponsoring the Phase 1 study of the agent in pediatric and adolescent patients with brain cancer or cancer that has spread to the central nervous system.
177Lu-DTPA-omburtamab is in Phase 1 clinical development. It is an investigational agent and is not approved by the FDA. The single Phase 1 trial is currently recruiting participants, with a planned enrollment of 18 patients, and no trials of this agent have been completed.
177Lu-DTPA-omburtamab is being evaluated in one Phase 1 trial, NCT07698899, titled A Study of 177Lu-DTPA-Omburtamab in Children and Adolescents With Brain Cancer or Cancer That Has Spread to the Central Nervous System (CNS). The trial is recruiting in the United States, has a planned enrollment of 18 participants, and is controlled without randomization or double blinding.
Yes, 25 mCi 177Lu-DTPA-omburtamab is another name used for 177Lu-DTPA-omburtamab. Both refer to the same investigational monoclonal antibody-based radiopharmaceutical developed by Y-mAbs Therapeutics, Inc. (YMAB) and studied in Phase 1 for recurrent medulloblastoma and central nervous system metastases.