RecruitingPhase 2NCT07301268

GI-102 Alone or With Pembrolizumab Before Surgery for Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma

MC230719 Window Of Opportunity Study Of GI-102 In Patients With Recurrent High-Grade Glioblastoma


Sponsor

Mayo Clinic

Enrollment

36 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial compares the effect of GI-102 alone and in combination with pembrolizumab given before surgery in treating patients with IDH wildtype glioblastoma and IDH mutated grade 4 astrocytoma that has come back after a period of improvement (recurrent) or that is growing, spreading, or getting worse (progressive). Glioblastoma is the most common and the most aggressive primary brain tumor in adults. Current standard of care includes surgical resection, radiation and chemotherapy. Treatment is often given before surgery (neoadjuvant therapy) to shrink the tumor and make it easier to remove. Treatment with GI-102, a bispecific fusion protein, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving GI-102 alone and in combination with pembrolizumab between neoadjuvant therapy and surgery may be safe, tolerable, and effective in treating patients with recurrent or progressive IDH wildtype glioblastoma and IDH mutated grade 4 astrocytoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Biospecimen Collection, a drug called Bispecific CD80-lgG4Fc-IL-2v Fusion Protein GI-102, and others for people with glioblastoma, idh-wildtype, progressive astrocytoma, idh-mutant, grade 4, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

DRUGBispecific CD80-lgG4Fc-IL-2v Fusion Protein GI-102

Given IV

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREEchocardiography Test

Undergo echocardiography

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

BIOLOGICALPembrolizumab

Given IV

PROCEDURESurgical Procedure

Undergo surgery


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07301268


Related Trials