Actively Recruiting
Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and/or IDH2 Mutations
Led by Hutchmed · Updated on 2025-08-01
52
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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...
- Fully informed about the study and voluntarily signed the informed consent form
- Age 18 years or older
- For Safety Lead-In Phase: Patients with gliomas confirmed to have IDH1 and/or IDH2 mutations
- For Perioperative Phase: Patients with definitive or suspected IDH1 and/or IDH2 mutated gliomas scheduled for surgery
- At least one measurable tumor lesion
- Karnofsky Performance Status score of 80% or higher
- Life expectancy of at least 12 weeks as judged by the investigator
- Adequate bone marrow and organ function
You will not qualify if you...
- Previous treatment with IDH inhibitors
- Unresolved toxic effects from prior cancer treatments greater than Grade 1 (except alopecia, skin pigmentation changes, and Grade 2 or less peripheral neuropathy)
- High-risk or unstable medical conditions as assessed by researchers
- Other active malignancies or history of other malignancies within 5 years before screening
- History of significant liver disease, including active viral hepatitis or alcoholic liver disease
- HIV infection
- Pregnant or breastfeeding women
- Conditions affecting drug absorption
- Any other condition that the investigator judges unsuitable for the study drug
AI-Screening
AI-Powered Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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