RecruitingPhase 1NCT07223034

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

20 participants

Start Date

Oct 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a radioactive drug called 177Lu-PSMA-617 — which is already approved for prostate cancer — in people with certain types of brain tumors called gliomas. The drug homes in on a protein called PSMA that some glioma tumors produce, delivering radiation directly to the tumor cells. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with a specific type of glioma (grade 2–4, IDH-wildtype, confirmed by biopsy) - Your tumor tests positive for the PSMA protein on a tissue test - You have already completed standard treatment including surgery and radiation therapy - Your kidney, liver, and blood counts are within acceptable ranges - You are on a low dose of steroids (4 mg dexamethasone or less) for at least 5 days before treatment **You may NOT be eligible if...** - Your tumor is located within 5 mm of the brainstem, optic nerves, or optic chiasm - You have received bevacizumab (Avastin) as part of your initial treatment - You have significant kidney disease (stage 2 or higher chronic kidney disease) - You are pregnant or plan to become pregnant - You have active HIV, hepatitis, or another serious active infection - Your life expectancy is less than 12 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTemozolomide

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.

DRUG177Lu-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.

DIAGNOSTIC_TEST68Ga-PSMA-PET scan/ MRI

Approximately 4 weeks after cycle 2 of radiopharmaceutical therapy (RPT), patients will undergo post-treatment imaging with 68Ga- PSMA PET and MRI

BEHAVIORALQuality of Life Questionnaires

baseline assessments, QOL surveys will be conducted with XeQOL and FACT-Br at 6 months and 12 months post treatment


Locations(7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

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NCT07223034


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