Radioactive drug lutathera takes on brain cancer in early trial
NCT ID NCT05109728
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 5 times
Summary
This phase 1 trial tests a radioactive drug called Lutathera in people with glioblastoma, an aggressive brain cancer. The study includes two groups: newly diagnosed patients receiving Lutathera with standard radiation and chemotherapy, and patients with recurrent glioblastoma receiving Lutathera alone. The main goal is to find the safest dose and check for side effects. About 65 adults will take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lutathera (lutetium Lu 177 dotatate)
- What this could lead to
- If this trial succeeds, it could point toward a new treatment option for glioblastoma, a difficult-to-treat brain cancer.
- What could go wrong
- This is an early phase 1 trial with only 65 participants, focused on safety and dosing. It is too soon to know if the treatment will be effective or have manageable side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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65 people
The number who actually took part.
- Started
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May 2022
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Col Uni Med Center New York Presby
New York, New York, 10032, United States
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MD Anderson Cancer Center Uni of Te
Houston, Texas, 77030, United States
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Novartis Investigative Site
Bron, 69677, France
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Novartis Investigative Site
Marseille, 13885, France
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Novartis Investigative Site
Porto, 4200-072, Portugal
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Novartis Investigative Site
Granada, Andalusia, 18014, Spain
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Novartis Investigative Site
Barcelona, 08035, Spain
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Novartis Investigative Site
Barcelona, 08036, Spain
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Novartis Investigative Site
Madrid, 28041, Spain
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Novartis Investigative Site
Madrid, 28050, Spain
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Novartis Investigative Site
Lausanne, 1011, Switzerland
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Novartis Investigative Site
Zurich, 8091, Switzerland
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University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
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University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792-1615, United States
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