* AAA601A52101
Research type
Research Study
Full title
A Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination with Radiotherapy with or without Temozolomide and in Recurrent Glioblastoma as Single Agent
IRAS ID
1004596
Contact name
Cristiana Balcu
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2021-003672-14
Clinicaltrials.gov Identifier
Research summary
Glioblastoma (GBM) is a type of very aggressive brain tumour. This phase 1b open label study aims to establish the recommended dose of [177Lu]Lu-DOTA-TATE (Lutathera) in combination with the standard of care or as single agent in 3 different groups of participants with Glioblastoma. In addition, this study will investigate the safety of [68Ga]Ga-DOTA-TATE and describe its uptake characteristics in participants with Glioblastoma.\nLutathera is a radioligand therapy, which is a targeted treatment that selectively delivers radiation to the tumour, with limited damage to surrounding tissues. Lutathera uses a radioactive particle (lutetium-177) attached to a targeting compound that binds to a specific protein on the tumor cells (somatostatin receptor type 2). Lutathera goes inside the tumour cells, where the radioactive component damages them from within. Lutathera is already approved in Europe, North America, and several other countries for the treatment of neuroendocrine tumours in adult patients (under the name “Lutathera”). It has been administered to more than 9000 patients with neuroendocrine tumours. However, this is the first study where Lutathera will be administered in patients with recurrent glioblastoma. \nAll participants will be scanned with [68Ga]Ga-DOTA-TATE (also called “NetSpot®”) PET/CT (or PET/MRI) during screening. NetSpot is a radioligand imaging agent, which helps visualise somatostatin receptors on the tumor cells. It has the same targeting compound as Lutathera and allows to see to which cells Lutathera will attach. It has been used for the diagnosis of neuroendocrine tumors and has been administered to more than 100,000 patients. Its use in glioblastoma will be tested in this study. A total of approximately 45 participants with glioblastoma in 3 parallel groups (Group 1 & 2 newly diagnosed , Group 3 recurrent glioblastoma). Participants will be in the study for about 4 weeks of screening, 4 months of treatment and 1 year of follow-up.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
22/NE/0139
Date of REC Opinion
28 Apr 2022
REC opinion
Further Information Favourable Opinion