177Lu-PSMA-617 treatment for IDH‑wildtype gliomas
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
Run by Memorial Sloan Kettering Cancer Center · NCT07223034 · Data updated 2026-11-12
This trial will test whether the radiopharmaceutical 177Lu-PSMA-617 is safe for adults with IDH‑wildtype gliomas who have completed standard surgery and radiation.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | bevacizumab |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Status | Recruiting |
| Started | October 27, 2025 |
| Main results expected | October 2027 |
| Study ends | October 2027 |
| Registry record updated | June 4, 2026 |
| Trial ID | NCT07223034 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with histologically confirmed IDH‑wildtype WHO grade 2–4 gliomas that are PSMA-positive on pathology, who have completed standard surgery and external beam radiotherapy, have ECOG ≤2, and meet organ function and steroid-dose requirements.
✕Probably not a fit
Patients whose tumors do not express PSMA, who have IDH‑mutant gliomas, or who have poor organ function or require high-dose steroids are unlikely to benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1 trial of the radioligand 177Lu-PSMA-617 in adults with histologically confirmed IDH1 R132H‑wildtype WHO grade 2–4 gliomas that show PSMA positivity by pathology. Eligible participants will undergo baseline 68Ga-PSMA PET and MRI imaging and receive one or more administrations of 177Lu-PSMA-617, with some participants also receiving temozolomide per protocol. The primary focus is dose escalation and safety monitoring, along with collection of imaging and quality-of-life data. Outcomes will determine tolerability and inform dosing for future studies of this targeted radiopharmaceutical in brain tumors.
Why it matters
Potential benefit: If safe and tolerable, this approach could provide a new targeted radioligand therapy option for PSMA-expressing IDH‑wildtype gliomas and potentially slow tumor progression.
How similar studies have gone: 177Lu-PSMA-617 has established clinical benefit in PSMA-positive prostate cancer, but its application to glioma is novel and supported only by limited prior human data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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 * 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
Where it's running
-
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States Recruiting -
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States Recruiting -
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States Recruiting -
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States Recruiting -
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States Recruiting -
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States Recruiting
Show 1 more location
-
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States Recruiting
Study contacts
- Principal investigator: Brandon Imber, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Brandon Imber, MD
- Email: imberb@mskcc.org
- Phone: 631-212-6346
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
YN003 injection in glioma patients
This phase 1 study tests whether YN003 injected IV is safe and tolerable for adults with recurrent or progressive glioma, and to explore how the drug behaves in the body and any early signs of activity.
-
Brain connectome project in adults with brain glioma undergoing surgery
This registry collects MRI data and clinical information from adults with glioma to see how brain networks relate to surgery and recovery.
-
Proton vs. Photon Radiation for Certain Grade 2–3 Gliomas
This study tests whether proton therapy can better preserve thinking and memory than photon therapy for adults with IDH-mutated grade 2–3 gliomas who need radiation.
-
Connectome-guided network planning for brain tumor surgery in eloquent areas
This study tests whether using patient-specific brain network maps from diffusion MRI can help surgeons plan and guide brain tumor removal in eloquent areas.
-
Temozolomide with or without WSD0922-FU for EGFR-Mutant, IDH-Wildtype Glioblastoma
This trial tests whether adding WSD0922-FU to temozolomide helps slow disease progression in adults with EGFR-mutant, IDH-wildtype glioblastoma.
-
AI-powered analysis of brain MRI to help glioma care
Doctors will use AI to study existing MRI scans and patient data from adults with glioma to see if it can help with non-invasive diagnosis and treatment planning.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.