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

StatusRecruiting
PhasePhase 2
Started2026-08-03
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Apr 30, 2029 → Sep 1, 2029
See other at-risk trials from Mayo Clinic

Amendment history

2026-10-02
notable
Primary completion pushed: 2029-04-30 → 2029-09-01
Completion moved earlier: 2034-04-30 → 2032-09-01
2026-04-02
notable
Suspended→Recruiting Study Status, Contacts/Locations v3
Primary completion pushed: 2029-01-31 → 2029-04-30
Completion pushed: 2034-01-31 → 2034-04-30
Trial statusSuspended→Recruiting
Reason stoppedDelay in drug shipping→not stated
Start date2026-01-29→2026-04-01
Study sitesdetails revised at 1 of 1 site
2026-01-30
notable
Recruiting→Suspended Study Identification, Study Status, Contacts/Locations v2
Trial statusRecruiting→Suspended
Reason stoppednot stated→Delay in drug shipping
Study sitesdetails revised at 1 of 1 site
Study title-19 characters
GI-102 Alone or in Combination With Pembrolizumab Before Surgery for the Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma
2026-01-29
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-12-29→confirmed 2026-01-29
Study sitesdetails revised at 1 of 1 site
2025-12-22
minor
Original filing
1,015 trials monitored
See 115 trials at risk
666 trials monitored
See 45 trials at risk
666 trials monitored
See 38 trials at risk
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.
Trial Details
NCT Number NCT07301268
Lead Sponsor Mayo Clinic
Conditions Glioblastoma, IDH-Wildtype, Progressive Astrocytoma, IDH-Mutant, Grade 4, Progressive Glioblastoma, Progressive Gliosarcoma, Recurrent Astrocytoma, IDH-Mutant, Grade 4, Recurrent Glioblastoma, IDH-Wildtype, Recurrent Gliosarcoma, Resectable Astrocytoma +1 more
Enrollment 36 participants
Start Date 2026-08-03
Primary Completion 2029-09-01 (estimated)
Study Completion 2032-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-10-01