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Using a targeted radioligand therapy for glioblastoma treatment

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

Phase 1 Interventional Novartis · NCT05109728

This study is testing a new targeted treatment called [177Lu]Lu-DOTA-TATE for people with newly diagnosed or recurrent glioblastoma to see if it works better when combined with standard treatments or on its own.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsbevacizumab
Locations15 sites (Boston, Massachusetts and 14 other locations)
Trial IDNCT05109728 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of [177Lu]Lu-DOTA-TATE, a radioligand therapy, in patients with newly diagnosed glioblastoma in combination with standard treatments, and in patients with recurrent glioblastoma as a standalone treatment. Participants will undergo a screening period to assess somatostatin receptor expression before being assigned to treatment groups. Group 1 will receive [177Lu]Lu-DOTA-TATE alongside radiotherapy and temozolomide, while Group 3 will receive [177Lu]Lu-DOTA-TATE alone. The study includes a follow-up period of 12 months to monitor outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed glioblastoma and adequate organ function.

Not a fit: Patients with non-enhancing glioblastoma or those who have not previously undergone standard therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with glioblastoma.

How similar studies have performed: Other studies have shown promise with radioligand therapies in treating various cancers, suggesting potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Boston, Massachusetts and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions GlioblastomaGBMRadioligand TherapyRLT[177Lu]Lu-DOTA-TATETemozolomideO-6-methylguanine-DNA methyltransferaseMGMT
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.