Status:
RECRUITING
A Study of 177Lu-PSMA-617 in People With Gliomas
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Glioma
Diffuse Astrocytoma, IDH-Wildtype (Grade 2-4)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
October 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07223034
Start Date
October 27 2025
End Date
October 1 2027
Last Update
November 4 2025
Active Locations (7)
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1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725