GI-102 for Recurrent or Progressive Glioblastoma and Grade 4 Astrocytoma
This study is looking at a treatment called GI-102, given alone or with pembrolizumab, before surgery for certain types of brain tumors. These include glioblastoma (a common and aggressive brain tumor) and grade 4 astrocytoma that has either come back or is getting worse. The goal is to see if GI-102, which is an immunotherapy (a treatment that uses your body's immune system), can help shrink the tumor and make it easier to remove during surgery. Researchers will be looking at changes in your tumor tissue for up to two years to see how the treatment works. This study is for adults aged 18 and older who have these specific types of brain tumors and are able to have surgery.
- Study design
- This is a Phase II interventional study, meaning it tests a new treatment in a small group of people. It plans to enroll 36 participants.
- What's involved
- You would undergo blood sample collection, CT scans, echocardiography, and MRI scans. The study involves receiving GI-102 intravenously (through a vein).
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will be looking at changes in your tumor tissue for up to two years after treatment.
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NCT07301268
GI-102 Alone or With Pembrolizumab Before Surgery for Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~36 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBispecific CD80-lgG4Fc-IL-2v Fusion Protein GI-102Computed TomographyEchocardiography TestMagnetic Resonance ImagingMultigated Acquisition Scan
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in pharmacodynamic markers of interest in tumor tissue
Measured over Up to 2 years
Conditions
Where it's being run
1 sites across 1 statesMinnesota1
Study leadership
- Jian L Campian, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age ≥ 18 years
Disease characteristics
Tissue-confirmed progressive or recurrent World Health Organization (WHO) grade IV IDH wildtype glioblastoma (including molecular glioblastoma and gliosarcoma); and IDH mutated WHO grade 4 astrocytoma
Candidates for surgical resection
Measurable or non-measurable disease as defined by Response Assessment in Neuro-Oncology (RANO) 2.0
Willing to undergo clinically indicated biopsy followed by resection of high-grade glioma at Mayo Clinic in Rochester, Minnesota (MN)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0,1, or 2 and Karnofsky performance status (KPS) ≥ 60
NOTE: PS must be assessed (again) ≤ 7 days prior to first dose of study drug
Hemoglobin ≥ 9.0 g/dL (obtained ≤ 15 days prior to registration)
Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 15 days prior to registration)
Platelet count ≥ 100,000/mm\^3 (obtained ≤ 15 days prior to registration)
Creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (per institutional standard) must be ≥ 45 ml/min (obtained ≤ 15 days prior to registration)
Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels \> 1.5 x ULN (obtained ≤ 15 days prior to registration)
Aspartate transaminase (AST) AND alanine transaminase (ALT) ≤ 2.5 x ULN (obtained ≤ 15 days prior to registration)
Amylase and lipase ≤ ULN (obtained ≤ 15 days prior to registration)
Left ventricular ejection fraction (LVEF) ≥ 50% (obtained ≤ 29 days prior to registration)
Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only
Persons of childbearing potential (POCBP) or able to father a child must be willing to use adequate contraception starting with first dose through 180 days after last dose
Provide written informed consent
Willingness to provide blood specimens for correlative research
Willingness to provide tissue specimens for correlative research
Willingness to provide written informed consent for the neuro-oncology biorepository (IRB 12-003458) for archiving of tissue, cerebrospinal fluid (CSF), and/or blood samples collected on this protocol
Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Exclusion
Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:
Pregnant persons
Nursing persons
Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception
Signs or symptoms of life-threatening raised intracranial pressure: as determined by the treating neurosurgeon, including severe headache, nausea, decreasing level of consciousness, precluding 4-7-day delay in scheduling neurosurgery (i.e., immediate surgery is indicated, and patient cannot wait)
Prior treatment
Received bevacizumab (AVASTIN) \< 30 days prior to registration
NOTE: Bevacizumab is allowed for symptom control during the adjuvant phase of the study
Increasing dexamethasone dose prior to registration
NOTE: Patients currently on dexamethasone must be on dose ≤ 4 mg/day at time of registration
Received chemotherapy \< 30 days prior to registration
Received a live vaccine \< 30 days prior to registration
Failure to recover from any adverse events related to any of the following therapies received prior to registration:
Major surgery \< 28 days prior to registration
Radiation therapy \< 14 days prior to registration
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Uncontrolled intercurrent illness including, but not limited to:
Ongoing or active infection requiring IV antibiotics
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Or psychiatric illness/social situations (e.g., drug addiction) that would limit compliance with study requirements
Receiving any other investigational agent at the time of registration
History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Active autoimmune disease that has required systemic treatment (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) ≤ 2 years prior to registration
NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Concurrent known active hepatitis B (i.e., known positive hepatitis B virus \[HBV\] surface antigen \[HBsAg\] reactive) AND known active hepatitis C (i.e., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] detected by polymerase chain reaction \[PCR\]). Note: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority
NOTE: Patients with known hepatitis B OR hepatitis C may be enrolled if they meet the following criteria:
Hepatitis B: Patients who are HBsAG positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Patients should remain on anti-viral therapy throughout the treatment phase of the trial and should follow local guidelines for HBV anti-viral therapy after completing study treatment
Hepatitis C: Patients with history of hepatitis C infection are eligible if HCV viral load is undetectable at screening. Patients must have completed curative anti-viral therapy at least 4 weeks prior to registration
Known history of active TB (Bacillus tuberculosis)
History of (non-infectious) pneumonitis or interstitial lung disease that required steroids, or current pneumonitis or interstitial lung disease
Hypersensitivity to pembrolizumab, IL-2, GI-102 or any of its excipients
History of allogeneic tissue/solid organ transplant
What this trial measures
- Change in pharmacodynamic markers of interest in tumor tissueUp to 2 years
Focused on an increase in CD8 T cell infiltration as well as a decrease in regulatory T cells in the tumor microenvironment (TME). Samples from stereotactic needle biopsy (pre-treatment) and resection (post-treatment) will be compared. For analyses looking at changes in measures before vs. after treatment, a paired sample t-test (or nonparametric Wilcoxon signed rank test if not sufficiently normally distributed) will have 80% power to detect an effect size of d = 0.675 within a treatment group (i.e. n=15 patients), and using a one-sided α of 0.05. Our utilization of a one-sided test in this setting is based on the fact that for changes before vs. after treatment, we are specifically focused on targeting an increase in CD8 T cell infiltration as well as a decrease in regulatory T cells in the TME.