Phase I Study of HMPL-306 in Adults With Gliomas Having IDH1 or IDH2 Mutations Evaluating Safety, Tolerability, and Early Effectiveness

What this Trial Is About

Researchers are studying the safety, tolerability, how the body processes and responds to the drug, and early effectiveness of HMPL-306 in patients with gliomas that have specific IDH1 andor IDH2 mutations. This is a Phase I clinical trial conducted at multiple centers, focusing on these brain tumors that carry these genetic changes. The study has two parts Part 1 is a safety lead-in phase to assess safety and dose-limiting toxicities during the first 28 days after starting HMPL-306. Part 2 is a perioperative phase where patients with IDH-mutated gliomas scheduled for surgery are randomized into groups to receive HMPL-306 or no treatment before surgery. The study will evaluate drug levels, effects on tumor-related molecules, and other pharmacokinetic and pharmacodynamic measures. Participants will be monitored for adverse effects and drug impact up to about 24 months. Researchers will collect data on dose-limiting toxicities within 28 days and follow participants for disease progression and drug response. Measurements include maximum drug concentration in blood, time to reach it, and tumor tissue levels of specific metabolites. Participants will undergo assessments throughout the study, including safety follow-up and pharmacological evaluations.

Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and/or IDH2 Mutations