A Study of 177Lu-PSMA-617 in People With Gliomas
LU-TARGET: A Phase 1 Study of Lutetium-177-PSMA-617 Adjuvant Radiotherapy for IDH Wild Type Gliomas Expressing PSMA Following Standard Treatment
1 other identifier
interventional
20
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2025
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 27, 2025
CompletedFirst Submitted
Initial submission to the registry
October 28, 2025
CompletedFirst Posted
Study publicly available on registry
October 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
November 4, 2025
November 1, 2025
1.9 years
October 28, 2025
November 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Descriptively report the toxicity
using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.
up to 8 weeks post first infusion
Secondary Outcomes (1)
Progression free survival (PFS)
2 years
Study Arms (1)
177Lu-PSMA-617
EXPERIMENTALPatients 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.
Interventions
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.
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.
Approximately 4 weeks after cycle 2 of radiopharmaceutical therapy (RPT), patients will undergo post-treatment imaging with 68Ga- PSMA PET and MRI
baseline assessments, QOL surveys will be conducted with XeQOL and FACT-Br at 6 months and 12 months post treatment
Eligibility Criteria
You may qualify if:
- 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
- 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
- +4 more criteria
You may not qualify if:
- 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
- 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
- Patients with known or suspected history of grade II or higher chronic kidney disease (CKD)
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Novartis Pharmaceuticalscollaborator
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brandon Imber, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2025
First Posted
October 31, 2025
Study Start
October 27, 2025
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
November 4, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
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.