177Lu-DTPA-omburtamab Radioimmunotherapy in Paediatric Patients
Research type
Research Study
Full title
A Phase I/II Dose-escalation and Expansion Cohort Study of Intracerebroventricular Radioimmunotherapy Using 177Lu-DTPA-omburtamab in Pediatric and Adolescent Patients with Recurrent or Refractory Medulloblastoma.
IRAS ID
283079
Contact name
Fernando Carceller Lechon
Contact email
Sponsor organisation
Y-mAbs Therapeutics Inc
Eudract number
2020-000670-22
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
143502, IND Number:
Duration of Study in the UK
5 years, 3 months, 2 days
Research summary
Y-mAbs Therapeutics, Inc (Y-mAbs) is developing 177Lu-DTPA-omburtamab for the treatment of patients aged 3 to 19 with recurrent or treatment-resistant medulloblastoma. This is the first time the product will be given to patients.
Omburtamab can potentially attach to many kinds of cancer cells, including medulloblastoma cells. To enable the killing of cancer cells, omburtamab is coupled to a radioactive compound called Lutetium-177 (177Lu). When given to a patient, 177Lu-DTPA-omburtamab can go directly to cancer cells to kill them, whereas less effect on normal cells is anticipated.This study is divided into 2 parts. In part 1 the highest dose that can be given without unacceptable side effects will be determined. Part 2 will look at the safety of repeated dosing. Patients can either participate in part 1 or part 2.
About 49 patients will take part in this study at approx 6 hospitals in the United States and 2 in the UK.
177Lu-DTPA-omburtamab will be administered through a permanent small plastic tube, Ommaya reservoir, in one of the ventricles in the brain put in by a neurosurgeon.
Patients in part 1 will receive a test (dosimetry) dose of 177Lu-DTPA-omburtamab in Week 1, and a maximum of two 5 week cycles of treatment doses.
In Part 2 of the study, up to 24 patients will be treated with the dose identified in Part 1 of the study. They will receive a maximum of 5 cycles of treatment of 177Lu-DTPA omburtamab.
After end of treatment, the patients will return to the clinic for follow-up visits every 12 weeks for one year after their first dose, followed by every 26 weeks until two years after the first dose of study drug. Annual contacts (visits or phone calls) will then be scheduled until 10 years after the last dose of study drug.
REC name
London - Central Research Ethics Committee
REC reference
20/LO/1116
Date of REC Opinion
7 Jan 2021
REC opinion
Further Information Favourable Opinion