Gliomas Harboring IDH1 and/or IDH2 MutationsPhase 1NCT07025018
Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and/or IDH2 Mutations
A Phase 1 study testing HMPL-306 in people with Gliomas Harboring IDH1 and/or IDH2 Mutations, run by Hutchmed at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gliomas Harboring IDH1 and/or IDH2 Mutations
- What is being tested?
- HMPL-306
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2025to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
Shuai Wu, 15316051226, wushuai0606@126.com
About this study
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
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
Read the 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.
- Being tested
- HMPL-306
- Keywords
- gliomas, randomized controlled, Multicenter, IDH1 mutations, IDH2 mutations, safety run-in, MRI/MRS examination, Phase I, clinical study, pharmacokinetics (PK), pharmacodynamics (PD), efficacy, HMPL-306, perioperative study
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMPL-306Drug
IDH small molecule inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Safety run-in | Experimental | This phase plans to enroll patients with gliomas of IDH1 and/or IDH2 mutations. The DLT will be evaluated during the first 28 days after the initial dosage. Receives: Drug: HMPL-306 |
| Perioperative study phase | Experimental | This phase plans to enroll patients with gliomas of definitive or suspected IDH1 and/or IDH2 mutations, who are scheduled for surgery. Patients who meet the inclusion criteria will be randomized to groups A, B, or C, to receive or not receive HMPL-306 treatment before surgery. Receives: Drug: HMPL-306 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects with Dose Limiting Toxicities (DLTs)
DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.
Measured: Up to 28 days after first dose of study drug
RP2D
Determine the Phase II recommended dose (RP2D) of HMPL-306 in patients with gliomas harboring IDH1 and/or IDH2 mutations based on a comprehensive assessment.
Measured: From first dose of study drug to the time of progressive disease, assessed up to 24 months on average
Secondary outcomes (4)
Maximum serum drug concentration
Blood samples will be obtained from all patients for determination of the maximum serum concentration of HMPL-306.
Measured: PK/PD weeks at screening through safety follow-up, assessed up to 24 months on average
Time to maximum concentration
Blood samples will be obtained from all patients for determination time to maximum concentration of HMPL-306.
Measured: PK/PD weeks at screening through safety follow-up, assessed up to 24 months on average
Area under the concentration-time curve (AUC)
Blood samples will be obtained from all patients for determination of the AUC of HMPL-306
Measured: PK/PD weeks at screening through safety follow-up, assessed up to 24 months on average
Concentration of 2-HG in brain tumor tissue
Brain tumor tissue will be obtained from suitable patients for determination concentration of 2-HG.
Measured: PK/PD weeks at screening through safety follow-up, assessed up to 24 months on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start15 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gliomas Harboring IDH1 and/or IDH2 MutationsStudies of the same condition, open and under way.
- More trials run by HutchmedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hutchmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinsong Wu, Principal investigator, Huashan HospitalBo Zhang, Study director, Hutchmed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025018
- Sponsor's protocol ID
- 2025-306-00CH1
- Status last verified
- Jul 2025
- First submitted
- 28 May 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07025018
- Acronym / sponsor ID
- 2025-306-00CH1
- Keywords
- gliomas, randomized controlled, Multicenter, IDH1 mutations, IDH2 mutations, safety run-in, MRI/MRS examination, Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- HutchmedIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safety run-in | Experimental | Drug: HMPL-306This phase plans to enroll patients with gliomas of IDH1 and/or IDH2 mutations. The DLT will be evaluated during the first 28 days after the initial dosage. |
| Perioperative study phase | Experimental | Drug: HMPL-306This phase plans to enroll patients with gliomas of definitive or suspected IDH1 and/or IDH2 mutations, who are scheduled for surgery. Patients who meet the inclusion criteria will be randomized to groups A, B, or C, to receive or not receive HMPL-306 treatment before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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% .
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMPL-306IDH small molecule inhibitor | Drug | Perioperative study phase, Safety run-in |
Primary outcome
Number of Subjects with Dose Limiting Toxicities (DLTs)
Time frame: Up to 28 days after first dose of study drug
DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.
RP2D
Time frame: From first dose of study drug to the time of progressive disease, assessed up to 24 months on average
Determine the Phase II recommended dose (RP2D) of HMPL-306 in patients with gliomas harboring IDH1 and/or IDH2 mutations based on a comprehensive assessment.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Gliomas Harboring IDH1 and/or IDH2 Mutations
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Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
Not yet recruitingPhase 1
VorAsidenib With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and/or IDH2 Mutations
Recurrent Glioma, IDH-mutant Gliomas
RecruitingObservational study
Multicenter Prospective Study on MRI AI Model for Midline Glioma Subtyping and Prognosis:
Gliomas Harboring IDH1 and/or IDH2 Mutations, Glioma Glioblastoma Multiforme
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jinsong Wu principal investigator
Huashan Hospital
Bo Zhang study director
Hutchmed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HMPL-306 in people with Gliomas Harboring IDH1 and/or IDH2 Mutations, run by Hutchmed at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tinghua Song (+86 21 2067 1822, tinghuas@hutch-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects with Dose Limiting Toxicities (DLTs) (time frame: Up to 28 days after first dose of study drug). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.