NCT07223034

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

LU-TARGET: A Phase 1 Study of Lutetium-177-PSMA-617 Adjuvant Radiotherapy for IDH Wild Type Gliomas Expressing PSMA Following Standard Treatment

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-10-27
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2025-10-31
• Last updated: 2025-11-04

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study