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.

Launched by NOVARTIS PHARMACEUTICALS · Oct 27, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called [177Lu]Lu-DOTA-TATE for patients with glioblastoma, a type of brain cancer. The study aims to find the best dose of this treatment when used alongside standard care for newly diagnosed patients, and as a standalone therapy for those whose glioblastoma has come back after previous treatment. The trial is currently looking for participants aged 18 and older who have been diagnosed with glioblastoma and meet specific health criteria.

To be eligible, newly diagnosed patients must have a visible tumor on an MRI and a good performance score, meaning they can carry out daily activities. For those with recurrent glioblastoma, they should have evidence of the disease returning and also meet certain health standards. Participants can expect to receive the study treatment and be closely monitored for its effects. It's important to note that those currently receiving other therapies for glioblastoma or with certain medical histories may not be able to participate. This trial offers a chance to explore a potentially beneficial treatment option for glioblastoma patients.

Gender

ALL

Eligibility 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 (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