A Study of 177Lu-PSMA-617 in People With Gliomas (NCT07223034) | Clinical Trial Compass
RecruitingPhase 1
A Study of 177Lu-PSMA-617 in People With Gliomas
United States20 participantsStarted 2025-10-27
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 fo…