High grade glioma is a group of aggressive malignant primary brain tumors, typically corresponding to WHO grade III and IV gliomas. These tumors are characterized by rapid progression, high recurrence risk, and poor long-term survival. Standard care usually combines surgery, radiotherapy, and chemotherapy.
The FDA has approved nivolumab with chemotherapy for pediatric and adult Hodgkin lymphoma patients aged 12+, based on clinical trial data showing improved survival. Separately, the agency cleared investigational new drug applications for FG001 for brain cancer surgery visualization and FRF-001 gene therapy for FOXG1 syndrome, allowing both to proceed to clinical trials.
The U.S. FDA has granted Fast Track designation to FluoGuide's FG001 as an intraoperative imaging agent for high-grade glioma surgical resection. The designation follows IND clearance in January and enables accelerated development and regulatory review.
Southern RNA and Providence Therapeutics will support a clinical trial testing personalized mRNA cancer vaccines for children with treatment-resistant brain tumors, marking the first multi-site pediatric study of its kind.
The U.S. Food and Drug Administration has cleared FluoGuide's Investigational New Drug application for FG001, enabling the company to proceed with a Phase 2 registration trial in high-grade glioma patients with first enrollment expected in Q2 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07499141 |
Use of Fluorescence in Gliomas |
COMPLETED | |
| NCT07424092 |
Intratumoral DNX-2401 for High Grade Pediatric Brain Tumors |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT07416188 |
Novel Indenoisoquinolone CMYC/TOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma |
RECRUITING | PHASE1/PHASE2 |
| NCT07286903 |
Fluorescence Enhanced Stereotactic Surgery (FESS) |
RECRUITING | |
| NCT07210632 |
Window Trial of Fluorescently Labeled Nivolumab-IRDye800 (Nivo800) in High Grade Glioma (HGG) |
RECRUITING | EARLY_PHASE1 |
| NCT07206849 |
Study of Tovorafenib in High-Grade Glioma and Diffuse Intrinsic Pontine Glioma (DIPG) |
NOT_YET_RECRUITING | PHASE2 |
| NCT06712875 |
MAPK Inhibition Combined With Anti-PD1 Therapy for BRAF-altered Pediatric Gliomas |
RECRUITING | PHASE1/PHASE2 |
| NCT06528691 |
Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors |
RECRUITING | PHASE2 |
| NCT06519682 |
A Pilot Study Investigating Upfront Adaptive Immunotherapy Approach in Children, Adolescent and Young Adult (CAYA) Patients With Replication-Repair Deficient (RRD) High-Grade Gliomas (HGG) |
RECRUITING | NA |
| NCT06504381 |
DB107-RRV, DB107-FC, and Radiation Therapy With or Without Temozolomide (TMZ) for High Grade Glioma |
RECRUITING | PHASE1/PHASE2 |
