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NCT07301268 · ClinicalTrials.gov registry record · Phase 2
GI-102 Alone or With Pembrolizumab Before Surgery for Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma
A Phase 2 study, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT07301268: Recruiting Phase 2 study, sponsored by Mayo Clinic.
NCT07301268 is a Phase 2 study that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07301268, a Phase 2 study, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Echocardiography Test
- DRUG Bispecific CD80-lgG4Fc-IL-2v Fusion Protein GI-102
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2026-04-01 |
| Est. Completion | 2034-04-30 |
| Phase | Phase 2 |
What NCT07301268 shows while recruiting
NCT07301268 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07301268 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07301268 about?
NCT07301268 is a clinical study titled "GI-102 Alone or With Pembrolizumab Before Surgery for Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma". 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 ge...
What is the current status of trial NCT07301268?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2026-04-01. Estimated completion is 2034-04-30.
What interventions are being tested in trial NCT07301268?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Echocardiography Test (PROCEDURE), Bispecific CD80-lgG4Fc-IL-2v Fusion Protein GI-102 (DRUG).
Who is sponsoring clinical trial NCT07301268?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07301268's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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