A Dose Finding Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination With Standard of Care and in Recurrent Glioblastoma as a Single Agent.

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of glioblastoma. You'll also need to be generally well enough, with healthy blood counts and organ function. Before you can be considered for the study treatment, a special scan (PET/CT or PET/MRI) will be done to confirm that your tumour has a specific marker that the new treatment targets.

If you've been recently diagnosed, your tumour must show up on a special type of MRI scan, and you need to be able to do your usual daily activities fairly well. If your glioblastoma has come back (recurred), this must be your first or second time it has returned, and you must have already had standard treatments like radiotherapy. Again, your tumour needs to show up on a special MRI, and you generally need to be able to get around and do most things for yourself.

There are also reasons you might not be able to join. For example, you can't be receiving other active treatments for glioblastoma outside of the study, or have widespread cancer affecting the thin linings around your brain and spinal cord. If you've had another type of cancer in the last three years (unless it was completely treated), or have recently received other radioactive treatments, you might also not be eligible.

If you decide to take part, the study starts with a 'screening period' lasting up to six weeks. During this time, you'll have several checks, including a special scan called a PET scan to see if your tumour has the right 'targets' for the new treatment. Once confirmed, you'll start the 'treatment period'.

If you're newly diagnosed, you'll receive the study treatment called [177Lu]Lu-DOTA-TATE every four weeks, up to six times. A few days after your first dose, you'll also start your standard radiotherapy and chemotherapy (temozolomide) as usual. The radiotherapy involves daily sessions for about six weeks, and the chemotherapy will be taken by mouth. During your treatment, the dose of temozolomide might be adjusted based on how you're tolerating it. If your glioblastoma has come back, you'll receive the study treatment [177Lu]Lu-DOTA-TATE on its own, every three weeks.

Each time you get the [177Lu]Lu-DOTA-TATE treatment, you'll also receive a special amino acid mixture through a drip. This is given to protect your kidneys. After your treatment period, you'll be followed up for a full 12 months to see how you're doing and how the treatment has affected you.