Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Bispecific CD80-lgG4Fc-IL-2v Fusion Protein GI-102 for Glioblastoma, IDH-Wildtype

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.

Official registry: https://clinicaltrials.gov/study/NCT07301268 · Mayo Clinic · enrollment listed as 36

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Biospecimen Collection, Bispecific CD80-lgG4Fc-IL-2v Fusion Protein GI-102, or Computed Tomography. The registry lists allocation as randomized. 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).

They plan to enroll about 36 people at Rochester. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.

Official title (unrewritten)

MC230719 Window of Opportunity Study of GI-102 in Patients With Recurrent High-Grade Glioma

Interventions: Biospecimen Collection, Bispecific CD80-lgG4Fc-IL-2v Fusion Protein GI-102, Computed Tomography, Echocardiography Test, Magnetic Resonance Imaging, Multigated Acquisition Scan, Pembrolizumab, Surgical Procedure

Primary outcome (registry wording): Change in pharmacodynamic markers of interest in tumor tissue

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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

Public study contact (from the registry)

Clinical Trials Referral Office

855-776-0015

mayocliniccancerstudies@mayo.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07301268 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07301268?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07301268?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary