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Radioactive drug lutathera takes on brain cancer in early trial

NCT ID NCT05109728

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

65 people

The number who actually took part.

Started

May 2022

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 100 years

Sex

Anyone

Healthy volunteers

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

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

  • Col Uni Med Center New York Presby

    New York, New York, 10032, United States

  • MD Anderson Cancer Center Uni of Te

    Houston, Texas, 77030, United States

  • Novartis Investigative Site

    Bron, 69677, France

  • Novartis Investigative Site

    Marseille, 13885, France

  • Novartis Investigative Site

    Porto, 4200-072, Portugal

  • Novartis Investigative Site

    Granada, Andalusia, 18014, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Madrid, 28050, Spain

  • Novartis Investigative Site

    Lausanne, 1011, Switzerland

  • Novartis Investigative Site

    Zurich, 8091, Switzerland

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Wisconsin School of Medicine and Public Health

    Madison, Wisconsin, 53792-1615, United States

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