A Study of 177Lu-PSMA-617 in People With Gliomas
Recruiting now · Phase 1
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT07223034
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 20
- Starts
- 2025-10-27
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2026-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- 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.
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
- 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 is running
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack, New York, United States (enrolling)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (enrolling)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (enrolling)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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