177Lu-DTPA-omburtamab Radioimmunotherapy in adults with CNS metastasis
Research type
Research Study
Full title
A Phase I/II Trial of Intracerebroventricular 177Lu-DTPA-Omburtamab Radioimmunotherapy for Leptomeningeal Metastasis from Solid Tumors
IRAS ID
283484
Contact name
Juanita Lopez
Contact email
Sponsor organisation
Y-mAbs Therapeutics Inc
Eudract number
2020-000669-18
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
145391 , IND
Duration of Study in the UK
4 years, 1 months, 26 days
Research summary
Y-mAbs Therapeutics Is developing 177 Lu-DTPA-omburtamab for the treatment of adult patients with Leptomeningeal Metastasis from Solid Tumours. This is the first time the product will be given to patients. Omburtamab can potentially attach to many kinds of cancer 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.
The study is divided into two parts. In each part study drug will be given in 5-week cycles. The aim of Part 1 is to identify the highest dose of 177Lu-DTPA-omburtamab that can be given to patients without unacceptable side effects. The aim of Part 2 is to test whether the highest treatment dose determined in part 1 of the study is safe in multiple patients. The study will take place at approx 8 hospitals in the US 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.
In part 1 approx 15 patients will receive a test dose of 177Lu-DTPA-omburtamab in Week 1, and a maximum of five 5 week cycles of treatment doses. After end of treatment, they will then return to the clinic for follow-up visits every 12 weeks until one year after their first dose.
In Part 2, up to 48 patients will be treated with the dose identified in Part 1 of the study. They will receive treatment with 177Lu-DTPA omburtamab for maximum of 104 weeks. After their last cycle of study drug they will return to the clinic for follow-up visits every 12 weeks until week 116 after their first dose.
REC name
London - Central Research Ethics Committee
REC reference
20/LO/1131
Date of REC Opinion
8 Jan 2021
REC opinion
Further Information Favourable Opinion