FG001 Near-Infrared Fluorescence Imaging During Tumor Resection in Newly Diagnosed High-Grade Glioma

INVESTIGATIONAL PLAN This is a prospective, multicenter, Phase 2 dose confirmation study of FG001 (0.45 mg/kg) with diagnostic purpose (optimal imaging agent) and a single group under NIR fluorescence imaging with FG001. Dosage will be 0.45 mg/kg FG001, single dose, intravenous injection, 12 to 19 hours before surgery. Neurosurgical tumor resection will be supported by NIR fluorescence imaging with FG001. Evaluation of MR imaging and histopathology will be conducted by central neuroradiologists and neuropathologists, respectively. Overall Design The overall trial design is an open-label assessment of FG001 to confirm the acceptability of the dose selected (0.45 mg/kg administered within 12-19 hours of surgery). Trial Schedule Eligible subjects will undergo the following sequence of events: * Screening (to be completed ≤30 days before surgery) * Pre-operative MRI (obtained within 48 hours) prior to surgery * Pretreatment (conducted in accordance with local institution practice) * Pre-dose Anti-drug antibody (ADA) sampling * Administration of FG001 12-19 hours prior to surgery * Pre-operative assessments (1 hour and 3-12 hours following IP administration) * Neurosurgical intervention with planned study assessments * Surgical Phase I: Dura View * Surgical Phase II: Cortex View * Surgical Phase III: Tumor View * Surgical Phase IV: Tumor Margin View * Surgical Phase V: Tumor Cavity View * Postoperative Assessments * Day 0 (±12 hours): Laboratory assessments, tumor characterization labs (including IDH and MGMT), and adverse events * Within 48 hours: MRI * Over 72 hours post-operative: collection of FG001 urine excretion metabolites * Over 48 hours post-operative: PK analysis * Day 3 (±12 hours): physical exam, vital signs, NANO scale, ECG and AEs * Post-operative Assessments: * Day 7 (±1 day): physical examination, safety assessments, Karnofsky Performance Status, Neurologic Assessment in Neuro-Oncology Scale, neurocognitive assessment, serum chemistries and hematology, anti-drug antibody sampling, ECG, adverse event monitoring, and concomitant medication review. * Week 6 (±1 week): follow-up assessments, including Karnofsky Performance Status, Neurologic Assessment in Neuro-Oncology Scale, neurocognitive assessment, quality-of-life assessment, adverse event monitoring, concomitant medication review, steroid use documentation, temozolomide compliance, and anti-drug antibody sampling. * 3 Months (±2 weeks): follow-up assessments, including MRI, Karnofsky Performance Status, Neurologic Assessment in Neuro-Oncology Scale, neurocognitive assessment, quality-of-life assessment, adverse event monitoring, concomitant medication review, temozolomide compliance, steroid use documentation, and disease progression and survival assessment. * 6 Months (±2 weeks): final follow-up assessments, including physical examination, vital signs, MRI, Karnofsky Performance Status, Neurologic Assessment in Neuro-Oncology Scale, neurocognitive assessment, quality-of-life assessment, adverse event monitoring, concomitant medication review, temozolomide compliance, steroid use documentation, and disease progression and survival assessment, as applicable.