HGG refers to high-grade glioma, a group of malignant intrinsic brain tumors classically corresponding to WHO grade III and IV gliomas. These tumors are biologically aggressive, typically recurrent, and associated with poor survival even with multimodal therapy. Treatment generally combines maximal safe resection, radiation, and chemotherapy.
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.
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 |
|---|---|---|---|
| NCT07210632 |
Window Trial of Fluorescently Labeled Nivolumab-IRDye800 (Nivo800) in High Grade Glioma (HGG) |
RECRUITING | EARLY_PHASE1 |
| NCT07179328 |
Focused Ultrasound Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy |
RECRUITING | PHASE1 |
| NCT05538130 |
A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors |
RECRUITING | PHASE1 |
| NCT05503797 |
A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations |
RECRUITING | PHASE2 |
