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

Launched by HUTCHMED · Jun 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called HMPL-306 to treat a type of brain tumor known as gliomas, specifically those with certain genetic changes called IDH1 and IDH2 mutations. The main goal of this early-phase (Phase 1) study is to find out if the medicine is safe and well-tolerated, how the body processes it, and whether it shows any signs of helping patients with these tumors. This study will take place at several medical centers and is not yet open for enrollment.

Adults aged 18 and older with gliomas that have these specific genetic mutations may be eligible to join, especially if they have at least one measurable tumor and are in reasonably good health with a good ability to carry out daily activities. Participants may be people preparing for surgery or those who already have measurable tumors. The study will exclude people who have previously taken similar medicines, have certain other health conditions, or are pregnant or breastfeeding. If you join, you can expect close monitoring by doctors, including tests to check how the medicine is working and to watch for any side effects. This trial aims to help find better treatments for patients with these specific brain tumors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Fully informed about the study and voluntarily sign the informed consent form (ICF).
• • 2. Age ≥ 18 years.
• • 3. 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.
• • 4. All patients must have at least one measurable lesion.
• • 5. Karnofsky Performance Status (KPS) score ≥ 80% .
• • 6. In the investigator's judgment, a life expectancy of ≥ 12 weeks.
• • 7. Sufficient bone marrow and organ function.
• Exclusion Criteria:
• • 1. Previous treatment with IDH inhibitors.
• • 2. Unresolved toxicity from previous antitumor treatments not reverted to ≤ Grade 1 (except for alopecia, skin pigmentation changes, and ≤ Grade 2 peripheral neuropathy).
• • 3. Patients assessed by researchers to have high-risk or unstable conditions.
• • 4. Having other malignancies or a history of other malignancies within 5 years prior to screening.
• • 5. History of clinically significant liver disease, including active infection with viral hepatitis, or other active hepatitis, alcoholic liver disease, cirrhosis, etc.
• • 6. Patients with HIV infection.
• • 7. Pregnancy (positive pregnancy test before dosing) or currently breastfeeding women.
• • 8. Presence of diseases or conditions affecting drug absorption.
• • 9. Any other conditions, in the investigator's judgment, unsuitable for the study drug, will result in exclusion.