A Multicenter, Randomized Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of HMPL-306 in Patients With Gliomas Harboring IDH1 and/or IDH2 Mutations
This study is a multicenter, randomized controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HMPL-306 in patients with gliomas harboring IDH1 and/or IDH2 mutations
• Fully informed about the study and voluntarily sign the informed consent form (ICF).
• Age ≥ 18 years.
• Safety Lead-In Phase: Patients with gliomas of a documented IDH1 and/or IDH2 mutation. Perioperative Study Phase: Patients with gliomas of definitive or suspected IDH1 and/or IDH2 mutations scheduled for surgery.
• All patients must have at least one measurable lesion.
• Karnofsky Performance Status (KPS) score ≥ 80% .
• In the investigator's judgment, a life expectancy of ≥ 12 weeks.
• Sufficient bone marrow and organ function.