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.

Korábbi kezelés

• Participant is receiving additional, concurrent, active therapy for glioblastoma outside of the trial
• History of another active malignancy in the previous 3 years prior to study entry
• Prior administration of a radiopharmaceutical unless 10 or more effective half-lives have elapsed before injection of [68Ga]Ga-DOTA-TATE or [177Lu]Lu-DOTA-TATE
  • Newly diagnosed glioblastoma (Group 1):
• Any prior treatment for glioma of any grade
  • Recurrent glioblastoma (Group 3 dose escalation and expansion):
• Early disease progression prior to 3 months from the completion of radiotherapy
• Previous treatment with bevacizumab for the treatment of glioblastoma with therapeutic intent, or with bevacizumab as supportive therapy (e.g. edema reduction) within 60 days of initiation of study treatment
  • Recurrent glioblastoma (Group 3 dose escalation only):
• More than 2 prior lines for systemic therapy
  • Recurrent glioblastoma (Group 3 dose expansion only):
• More than 1 prior line for systemic therapy

Más betegség

• Extensive leptomeningeal disease

Egyéb

• Common Criteria:

• 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