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

Trial ID: NCT05109728

Interventional - Phase 1 - Active, not recruiting

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

Conditions

• Glioblastoma

Interventions

• [177Lu]Lu-DOTA-TATE
• [68Ga]Ga-DOTA-TATE
• Temozolomide
• Radiotherapy

Eligibility

Inclusion 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:
• 1. Residual and measurable disease post-surgery is not required but surgery must have confirmed the diagnosis of recurrence
• 2. 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
• Key

Exclusion criteria

• Common Criteria:
• Participant is receiving additional, concurrent, active therapy for glioblastoma outside of the trial
• Extensive leptomeningeal disease
• 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

Sponsor

Novartis Pharmaceuticals

Source: ClinicalTrials.gov

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