OncoMatch/Clinical Trials/NCT07223034
A Study of 177Lu-PSMA-617 in People With Gliomas
Is NCT07223034 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including Temozolomide and 177Lu-PSMA-617 for glioma.
Treatment: Temozolomide · 177Lu-PSMA-617 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Radioligand therapy
Cancer type
Glioblastoma
Diffuse Intrinsic Pontine Glioma
Biomarker criteria
Required: IDH1 R132H wild-type
IDH1 R132H-wildtype
Required: FOLH1 overexpression (PSMA positive pathological stain (by immunohistochemistry))
PSMA positive pathological stain (by immunohistochemistry) of baseline (pre-radiotherapy) resection or biopsy sample
Excluded: IDH1 non-canonical mutation (i.e., non-R132H)
Patient known to harbor any other non-canonical IDH mutations (i.e., non-R132H)
Allowed: H3F3A (H3 K27M) K27-altered
Diffuse midline glioma, H3 K27-altered
Allowed: H3F3A (H3 K27M) G34-mutant
Diffuse hemispheric glioma, H3 G34-mutant
Allowed: H3F3A (H3 K27M) wild-type
Diffuse pediatric-type high-grade glioma, H3-wildtype and IDH-wildtype
Allowed: IDH1 wild-type
Diffuse pediatric-type high-grade glioma, H3-wildtype and IDH-wildtype
Disease stage
Required: Stage GRADE 2, GRADE 3, GRADE 4 (WHO)
WHO grade 2-4 glioma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard of care therapy — including surgery (for resectable tumors) and adjuvant EBRT for glioma
Completion of standard of care therapy including surgery (for resectable tumors) and adjuvant EBRT for glioma
Cannot have received: bevacizumab (bevacizumab)
Receipt of bevacizumab as part of the initial treatment for glioma
Cannot have received: Radium223, Strontium89 or Samarium153 containing compounds (Radium223, Strontium89, Samarium153)
prior exposure to prior Radium223, Strontium89 or Samarium153 containing compounds
Cannot have received: investigational agents
Receipt of any other investigational agents or participation in a concurrent treatment protocol
Cannot have received: radiation therapy
Exception: prior RT to > 25% of the skeleton
prior RT to > 25% of the skeleton
Lab requirements
Blood counts
total white blood count > 3.0 k/mcl; anc ≥ 1.5 k/mcl; platelets ≥ 100 k/mcl; hemoglobin ≥ 9 g/dl
Kidney function
serum creatinine level < 1.5 x uln or egfr > 60 ml/min
Liver function
alt and ast ≤ 2.5 x uln; albumin > 2 g/dl; bilirubin < 3 x uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) · Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07223034 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior bevacizumab, Radium223, Strontium89 or Samarium153 containing compounds, investigational agents disqualifies patients from enrollment.
Does this trial require IDH1?
Yes, IDH1 R132H wild-type is a required biomarker for enrollment.
Does this trial require FOLH1?
Yes, FOLH1 overexpression is a required biomarker for enrollment.
Are patients with IDH1 alterations eligible?
No. IDH1 non-canonical mutation (i.e., non-R132H) is an exclusion criterion.
What disease stage is eligible?
Stage GRADE 2 or GRADE 3 or GRADE 4 is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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