GliomaPhase 1NCT07223034
A Study of 177Lu-PSMA-617 in People With Gliomas
A Phase 1 study testing Temozolomide, 177Lu-PSMA-617 and 68Ga-PSMA-PET scan/ MRI in people with Glioma and Diffuse Astrocytoma, IDH-Wildtype (Grade 2-4), run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The researchers are doing this study to find out whether the radiopharmaceutical therapy (RPT) 177Lu-PSMA-617 is a safe treatment for people with IDH wild type glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Diffuse Astrocytoma, IDH-Wildtype (Grade 2-4), Glioblastoma, IDH-wildtype
- What is being tested?
- Temozolomide, 177Lu-PSMA-617 and 68Ga-PSMA-PET scan/ MRI
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 7 sitesUnited States
- Study dates
- 27 Oct 2025to Oct 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed histologic diagnosis of a WHO grade 2-4 glioma that is IDH1 R132H-wildtype, including the following:
- Diffuse astrocytoma, IDH-wildtype (grade 2-4)
- Glioblastoma, IDH-wildtype
- Diffuse midline glioma, H3 K27-altered
- Diffuse hemispheric glioma, H3 G34-mutant
- Diffuse pediatric-type high-grade glioma, H3-wildtype and IDH-wildtype PSMA positive pathological stain (by immunohistochemistry) of baseline (pre-radiotherapy) resection or biopsy sample
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- Completion of standard of care therapy including surgery (for resectable tumors) and adjuvant EBRT for glioma
- Patients must be on a dose of 4 mg or less of dexamethasone (or dexamethasone equivalent steroid) for 5 days prior to first planned dose of radiopharmaceutical
- Age ≥ 18
- ECOG ≤ 2
- Serum creatinine level < 1.5 x ULN or EGFR > 60 mL/min
- Liver laboratory values: ALT and AST ≤ 2.5 x ULN; Albumin > 2 g/ dL; Bilirubin < 3 X ULN
- Normal organ and marrow function as defined as the following
- Total white blood count > 3.0 K/mcL
- ANC ≥ 1.5 K/mcL
- Platelets ≥ 100 K/mcL
- Hemoglobin ≥ 9 g/dL
- Adequate contraception prior to registration (see section 9.0)
- Ability to understand, and willingness to sign the informed consent.
Who cannot join
- Patient known to harbor any other non-canonical IDH mutations (i.e., non-R132H)
- Target lesion within 5 mm of either the brainstem, optic chiasm or optic nerves Receipt of bevacizumab as part of the initial treatment for glioma
- Life expectancy less than 12 weeks
- Nonhealing wound, ulcer or bone fracture
- History of severe brain injury
- Patient not eligible for sequential MRI evaluations
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- Patients with prior RT to > 25% of the skeleton or prior exposure to prior Radium223, Strontium89 or Samarium153 containing compounds
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
- Unable to tolerate the PSMA PET/MR or PSMA PET/CT
- History of viral hepatitis or chronic liver disease with active symptoms
- History of pituitary or adrenal dysfunction
- Previously diagnosed active infection (e.g., human immunodeficiency virus [HIV] or viral hepatitis)
- Any condition that in the opinion of the investigator, would preclude participation in this study
- Receipt of any other investigational agents or participation in a concurrent treatment protocol
- Known allergies, hypersensitivities, or intolerance to 68Ga-PSMA-11/177Lu-PSMA-617 or its inactive compounding components
- Current or planned pregnancy
- Refusal to comply with detailed contraception requirements
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Thomas Kaley, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Brandon Imber, MD, 631-212-6346
- Recruiting
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
Brandon Imber, MD, 631-212-6346
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Brandon Imber, MD, 631-212-6346
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Brandon Imber, MD, 631-212-6346
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Brandon Imber, MD, 631-212-6346
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Brandon Imber, MD, 631-212-6346
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Brandon Imber, MD, 631-212-6346
About this study
Official title: LU-TARGET: A Phase 1 Study of Lutetium-177-PSMA-617 Adjuvant Radiotherapy for IDH Wild Type Gliomas Expressing PSMA Following Standard Treatment
The researchers are doing this study to find out whether the radiopharmaceutical therapy (RPT) 177Lu-PSMA-617 is a safe treatment for people with IDH wild type glioma.
- Conditions
- Glioma, Diffuse Astrocytoma, IDH-Wildtype (Grade 2-4), Glioblastoma, IDH-wildtype, Diffuse Midline Glioma, H3 K27-Altered, Diffuse Hemispheric Glioma, H3 G34-mutant, Diffuse Pediatric-type High-grade Glioma, H3-wildtype and IDH-wildtype
- Being tested
- Temozolomide, 177Lu-PSMA-617, 68Ga-PSMA-PET scan/ MRI, Quality of Life Questionnaires
- Medical subject headings
- Glioma, Astrocytoma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Patients will begin taking Temozolomide orally on the first 5 days of each 28-day cycle. The first dose will be given the evening before the first infusion of 177Lu-PSMA- 617.
177Lu-PSMA-617Drug
This agent will be given for 2-6 total doses, spaced 4 weeks (+/-1 week) apart. This will be administered on the 2nd day of the first two cycles of SOC adjuvant temozolomide.
68Ga-PSMA-PET scan/ MRIDiagnostic test
Approximately 4 weeks after cycle 2 of radiopharmaceutical therapy (RPT), patients will undergo post-treatment imaging with 68Ga- PSMA PET and MRI
Quality of Life QuestionnairesBehavioural
baseline assessments, QOL surveys will be conducted with XeQOL and FACT-Br at 6 months and 12 months post treatment
| Study group | Role | What they receive |
|---|---|---|
| 177Lu-PSMA-617 | Experimental | Patients will begin the first and second cycles of adjuvant Temozolomide (TMZ) the night before the first and second infusions of 177Lu-PSMA-617, respectively. Post-treatment, MRI of the brain will be obtained every 2 months, as per standard of care. A 68Ga-PSMA-PET scan will be performed with the MRI of the brain 1 month after the second cycle of 177Lu-PSMA-617 and again at evidence of disease progression. Receives: Drug: Temozolomide; Drug: 177Lu-PSMA-617; Diagnostic Test: 68Ga-PSMA-PET scan/ MRI; Behavioral: Quality of Life Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptively report the toxicity
using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Measured: up to 8 weeks post first infusion
Secondary outcomes (1)
Progression free survival (PFS)
PFS will be defined as the time from treatment initiation to progression of disease as noted radiographically per RANO 2.0 criteria or death, whichever occurred first, and will be analyzed using the Kaplan-Meier method
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2025
- Study start27 Oct 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Brandon Imber, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223034
- Sponsor's protocol ID
- 25-169
- Status last verified
- Jun 2026
- First submitted
- 28 Oct 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LU-TARGET: A Phase 1 Study of Lutetium-177-PSMA-617 Adjuvant Radiotherapy for IDH Wild Type Gliomas Expressing PSMA Following Standard Treatment
- ClinicalTrials.gov ID
- NCT07223034
- Acronym / sponsor ID
- 25-169
- Conditions
- Glioma, Diffuse Astrocytoma, IDH-Wildtype (Grade 2-4), Glioblastoma, IDH-wildtype, Diffuse Midline Glioma, H3 K27-Altered, Diffuse Hemispheric Glioma, H3 G34-mutant, Diffuse Pediatric-type High-grade Glioma, H3-wildtype and IDH-wildtype
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 31 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers are doing this study to find out whether the radiopharmaceutical therapy (RPT) 177Lu-PSMA-617 is a safe treatment for people with IDH wild type glioma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 177Lu-PSMA-617 | Experimental | Drug: Temozolomide, Drug: 177Lu-PSMA-617, Diagnostic Test: 68Ga-PSMA-PET scan/ MRI, Behavioral: Quality of Life QuestionnairesPatients will begin the first and second cycles of adjuvant Temozolomide (TMZ) the night before the first and second infusions of 177Lu-PSMA-617, respectively. Post-treatment, MRI of the brain will be obtained every 2 months, as per standard of care. A 68Ga-PSMA-PET scan will be performed with the MRI of the brain 1 month after the second cycle of 177Lu-PSMA-617 and again at evidence of disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Confirmed histologic diagnosis of a WHO grade 2-4 glioma that is IDH1 R132H-wildtype, including the following:
- Completion of standard of care therapy including surgery (for resectable tumors) and adjuvant EBRT for glioma
- Patients must be on a dose of 4 mg or less of dexamethasone (or dexamethasone equivalent steroid) for 5 days prior to first planned dose of radiopharmaceutical
- Age ≥ 18
- ECOG ≤ 2
Key exclusion criteria (17 listed)
- Patient known to harbor any other non-canonical IDH mutations (i.e., non-R132H)
- Target lesion within 5 mm of either the brainstem, optic chiasm or optic nerves Receipt of bevacizumab as part of the initial treatment for glioma
- Life expectancy less than 12 weeks
- Nonhealing wound, ulcer or bone fracture
- History of severe brain injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TemozolomidePatients will begin taking Temozolomide orally on the first 5 days of each 28-day cycle. The first dose will be given the evening before the first infusion of 177Lu-PSMA- 617. | Drug | 177Lu-PSMA-617 |
| 177Lu-PSMA-617This agent will be given for 2-6 total doses, spaced 4 weeks (+/-1 week) apart. This will be administered on the 2nd day of the first two cycles of SOC adjuvant temozolomide. | Drug | 177Lu-PSMA-617 |
| 68Ga-PSMA-PET scan/ MRIApproximately 4 weeks after cycle 2 of radiopharmaceutical therapy (RPT), patients will undergo post-treatment imaging with 68Ga- PSMA PET and MRI | Diagnostic test | 177Lu-PSMA-617 |
| Quality of Life Questionnairesbaseline assessments, QOL surveys will be conducted with XeQOL and FACT-Br at 6 months and 12 months post treatment | Behavioural | 177Lu-PSMA-617 |
Primary outcome
Descriptively report the toxicity
Time frame: up to 8 weeks post first infusion
using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.
1 secondary outcome
Progression free survival (PFS)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Kaley, MD contact
Brandon Imber, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Temozolomide, 177Lu-PSMA-617 and 68Ga-PSMA-PET scan/ MRI in people with Glioma and Diffuse Astrocytoma, IDH-Wildtype (Grade 2-4), run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brandon Imber, MD (631-212-6346, imberb@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptively report the toxicity (time frame: up to 8 weeks post first infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.