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.

• Status: Not yet recruiting
• Trial end date: 2024-11-26
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to establish the recommended dose of [177Lu]Lu-DOTA-TATE in combination with the standard of care or as single agent in three different groups of participants with Glioblastoma. In addition, this study will investigate the safety of [68Ga]Ga-DOTA-TATE and describe its uptake characteristics in participants with Glioblastoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: 1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid; Lutetium Lu 177 dotatate; Temozolomide

Criteria

Key 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:

• Presence of Gadolinium enhancing tumor in pre-surgery magnetic resonance imaging (MRI)

• Karnofsky Performance Score (KPS) >= 70 %

Recurrent Glioblastoma:

• Participant has experienced first or second recurrence of their glioblastoma, after standard or experimental therapy that includes prior radiation therapy

• 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 scan at the tumor region

• Presence of Gadolinium enhancement in the tumor region in MRI at the time of diagnosis of tumor recurrence

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

Newly Diagnosed Glioblastoma:

• Any prior treatment for glioma of any grade

Recurrent Glioblastoma:

• Early disease progression prior to 3 months from the completion of radiotherapy

• More than 2 prior lines for systemic therapy

• Previous treatment with bevacizumab