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
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
∙ Common Criteria:
• Participant is \>= 18 years on the day of signing informed consent form
• Histologically confirmed glioblastoma
• Adequate bone marrow, organ function and electrolyte values
∙ Newly diagnosed glioblastoma (Group 1):
• Presence of Gadolinium enhancing tumor in pre-surgery magnetic resonance imaging (MRI)
• Karnofsky Performance Score (KPS) \>= 70 %
∙ Recurrent glioblastoma (Group 3 dose Escalation only):
∙ • Participant has experienced first or second recurrence of their glioblastoma, after standard or experimental therapy that includes prior EBRT
∙ Recurrent glioblastoma (Group 3 dose escalation and expansion):
• Evidence of recurrent disease demonstrated by disease progression using modified Response Assessment in Neuro-Oncology (mRANO) criteria
• KPS \>= 60 %
• \[68Ga\]Ga-DOTA-TATE uptake by positron emission tomography/computed tomography (PET/CT) or PET/MRI at the tumor region
• Presence of Gadolinium enhancement in the tumor region in MRI at the time of diagnosis of tumor recurrence
• A second surgery for glioblastoma is allowed provided that the following criteria are met:
‣ Residual and measurable disease post-surgery is not required but surgery must have confirmed the diagnosis of recurrence
⁃ Surgery completed at least 2 weeks prior to study treatment initiation, with post-surgery recovery without any complications related to surgical procedure
‣ Recurrent glioblastoma (Group 3 Dose Expansion only):
• Patients experiencing first recurrence of their glioblastoma, after standard or experimental therapy that includes prior EBRT