Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and/or IDH2 Mutations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HMPL-306.
- Who it may be relevant to
- Registry conditions: Gliomas Harboring IDH1 and/or IDH2 Mutations. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
Detailed description
HMPL-306 is a dual IDH1/2 inhibitor. This 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.
The study consists of 2 parts: Part 1 (safety lead-in phase) and Part 2 (perioperative phase). Part 1 will determine safety and DLT. Part 2 will administer the HMPL-306 or no treatment to mIDH-positive gliomas.
Interventions
- Drug HMPL-306
IDH small molecule inhibitor
Primary outcome measures
- Number of Subjects with Dose Limiting Toxicities (DLTs) [Time frame: Up to 28 days after first dose of study drug]
- RP2D [Time frame: From first dose of study drug to the time of progressive disease, assessed up to 24 months on average]
Secondary outcome measures (4)
- Maximum serum drug concentration [Time frame: PK/PD weeks at screening through safety follow-up, assessed up to 24 months on average]
- Time to maximum concentration [Time frame: PK/PD weeks at screening through safety follow-up, assessed up to 24 months on average]
- Area under the concentration-time curve (AUC) [Time frame: PK/PD weeks at screening through safety follow-up, assessed up to 24 months on average]
- Concentration of 2-HG in brain tumor tissue [Time frame: PK/PD weeks at screening through safety follow-up, assessed up to 24 months on average]
Eligibility criteria
Inclusion criteria
- Fully informed about the study and voluntarily sign the informed consent form (ICF).
- Age ≥ 18 years.
- 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.
- All patients must have at least one measurable lesion.
- Karnofsky Performance Status (KPS) score ≥ 80% .
- In the investigator's judgment, a life expectancy of ≥ 12 weeks.
- Sufficient bone marrow and organ function.
Exclusion criteria
- Previous treatment with IDH inhibitors.
- Unresolved toxicity from previous antitumor treatments not reverted to ≤ Grade 1 (except for alopecia, skin pigmentation changes, and ≤ Grade 2 peripheral neuropathy).
- Patients assessed by researchers to have high-risk or unstable conditions.
- Having other malignancies or a history of other malignancies within 5 years prior to screening.
- History of clinically significant liver disease, including active infection with viral hepatitis, or other active hepatitis, alcoholic liver disease, cirrhosis, etc.
- Patients with HIV infection.
- Pregnancy (positive pregnancy test before dosing) or currently breastfeeding women.
- Presence of diseases or conditions affecting drug absorption.
- Any other conditions, in the investigator's judgment, unsuitable for the study drug, will result in exclusion.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Huashan Hospital affiliated to Fudan University — Shanghai
Identifiers
NCT: NCT07025018 · 2025-306-00CH1