NCT07223034 A Study of 177Lu-PSMA-617 in People With Gliomas
| NCT ID | NCT07223034 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-10-27 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-10-27 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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 * 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
Contact & Investigator
Brandon Imber, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT07223034 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07223034 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07223034 currently recruiting?
Yes, NCT07223034 is actively recruiting participants. Contact the research team at imberb@mskcc.org for enrollment information.
Where is the NCT07223034 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 3 additional locations.
Who is sponsoring the NCT07223034 clinical trial?
NCT07223034 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Brandon Imber, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 20 participants.