Dose Finding Study of [177Lu]Lu-NeoB in Newly Diagnosed Glioblastoma and in Recurrent Glioblastoma

This study is looking for adults aged 18 or older who have been diagnosed with glioblastoma. You must have a confirmed glioblastoma diagnosis from a tissue sample (biopsy or surgery).

If you're taking steroid medication like dexamethasone, you'll need to be on a stable low dose (4mg/day or less) for at least a week before starting the study treatment. You'll also need to have healthy blood counts and good kidney and liver function, as shown by specific blood tests.

For those newly diagnosed, your tumour tissue needs to be available for further checks, and your MRI scan should show that the tumour lights up with a special dye. If your glioblastoma has come back, the special [68Ga]Ga-NeoB PET scan must show activity in the tumour area, and you should be experiencing your first or second recurrence after your initial treatment.

If you join this study for newly diagnosed glioblastoma, you will receive the new treatment, [177Lu]Lu-NeoB, alongside your standard chemotherapy and radiotherapy. This new treatment is given every four weeks for six rounds. If it's helping and you're tolerating it well, you might receive up to four more doses, making a total of ten. You'll have regular checks, possibly weekly, to monitor your safety and how well the treatment is working. This will include blood tests and contrast-enhanced MRI scans every eight weeks.

Before treatment, you'll also have a special [68Ga]Ga-NeoB PET/CT or PET/MRI scan. If you join the study for recurrent glioblastoma, you will receive [177Lu]Lu-NeoB as a standalone treatment. The study will carefully increase the dose for groups of participants to find the best and safest amount. The total duration of your participation will depend on how you respond to the treatment and the study plan, but involves regular assessments for safety and effectiveness.