Actively Recruiting
A Multicenter, Randomized Controlled Phase I Study Evaluating Safety and Early Effects of HMPL-306 in Patients With Gliomas Having IDH1 and/or IDH2 Mutations
Led by Hutchmed · Updated on 2025-08-01
52
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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 and/or 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.
CONDITIONS
Brief Title
Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and/or IDH2 Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Signed informed consent form
- Diagnosed with gliomas having documented or suspected IDH1 and/or IDH2 mutations
- Scheduled for surgery if in perioperative phase
- At least one measurable lesion
- Karnofsky Performance Status score of 80% or higher
- Life expectancy of at least 12 weeks as judged by investigator
- Adequate bone marrow and organ function
You will not qualify if you...
- Prior treatment with IDH inhibitors
- Unresolved toxicities from previous antitumor treatments except certain mild side effects
- High-risk or unstable medical conditions
- Other malignancies or history of malignancy within past 5 years
- Clinically significant liver disease or active hepatitis
- HIV infection
- Pregnancy or breastfeeding
- Conditions affecting drug absorption
- Any other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 28 days
Participants receive HMPL-306 to evaluate safety and dose limiting toxicities during the first 28 days after initial dosage.
Multiple visits during the 28-day period
Duration - Up to the time of surgery
Participants receive HMPL-306 or no treatment before surgery depending on randomization, to assess early effects in gliomas with IDH1 and/or IDH2 mutations.
Visits according to perioperative schedule
Trial Site Locations
Total: 1 location
1
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
T
Tinghua Song
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here