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A Study of 177Lu-PSMA-617 in People With Gliomas

NCT07223034 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-11-04

No results posted yet for this study

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.

Conditions

  • 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

Interventions

DRUG

Temozolomide

Patients will begin taking Temozolomide orally on the first 5 days of each 28-day cycle. The first dose will be given the evening before the first infusion of 177Lu-PSMA- 617.

DRUG

177Lu-PSMA-617

This agent will be given for 2-6 total doses, spaced 4 weeks (+/-1 week) apart. This will be administered on the 2nd day of the first two cycles of SOC adjuvant temozolomide.

DIAGNOSTIC_TEST

68Ga-PSMA-PET scan/ MRI

Approximately 4 weeks after cycle 2 of radiopharmaceutical therapy (RPT), patients will undergo post-treatment imaging with 68Ga- PSMA PET and MRI

BEHAVIORAL

Quality of Life Questionnaires

baseline assessments, QOL surveys will be conducted with XeQOL and FACT-Br at 6 months and 12 months post treatment

Sponsors & Collaborators

Principal Investigators

  • Brandon Imber, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-27
Primary Completion
2027-10-31
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07223034 on ClinicalTrials.gov