HMPL-306 treatment for gliomas with IDH1 or IDH2 mutations.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

HMPL-306 is a dual IDH1/2 inhibitor being tested in a multicenter, randomized, controlled Phase I protocol for adults with IDH1- or IDH2‑mutant gliomas. The study has two parts: Part 1 is a safety lead‑in to determine dose‑limiting toxicities and tolerability, and Part 2 is a perioperative randomized comparison of pre‑surgical HMPL‑306 versus no pre‑surgical treatment. Key outcomes include safety, tolerability, pharmacokinetics, pharmacodynamics in tumor tissue, and preliminary signals of antitumor activity. Eligible patients are adults with measurable IDH‑mutant gliomas, adequate organ function, and KPS ≥80 who can attend participating sites (one listed: Huashan Hospital, Fudan University, Shanghai).

Why it matters

Who can join: the full rules

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.

Where it's running

• Huashan Hospital affiliated to Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Jinsong Wu — Huashan Hospital
• Study coordinator: Tinghua Song
• Email: tinghuas@hutch-med.com
• Phone: +86 21 2067 1822

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.