Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 MutationPhase 3NCT07912398
HMPL-306 in Participants With Postoperative Residual or Recurrent Grade 2 Glioma Harboring IDH1 or IDH2 Mutations
A Phase 3 study testing HMPL-306 tablet in people with Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation, run by Hutchmed.
Trial summary
This study is a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial evaluating the efficacy and safety of HMPL-306 in participants with postoperative residual or recurrent grade 2 gliomas carrying IDH1 or IDH2 mutations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
- What is being tested?
- HMPL-306 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Sep 2032
- Phase
- Phase 3
- 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
- Have fully understood this study and voluntarily signed the ICF, willing to complete the planned visits, treatments, procedures, and laboratory tests during the study period;
- Age ≥18 years old;
- Patients with grade 2 oligodendroglioma or grade 2 astrocytoma;
- Have confirmed presence of IDH1 or IDH2 gene mutation, and obtained chromosome 1p/19q status;
- Have undergone at least 1 glioma surgery and have not received any other anti-glioma treatments, including chemotherapy and radiotherapy;
- Confirmed by BIRC, at least 1 measurable non-enhancing lesion meeting RANO 2.0 criteria using two-dimensional magnetic resonance imaging (MRI) measurement at screening;
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- KPS ≥80;
- As judged by the investigator, life expectancy of ≥12 months;
- Adequate bone marrow, hepatic, renal, and coagulation function
Who cannot join
- Previously received any other anti-glioma treatment except for surgery, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, or biological therapy, etc.;
- Participants assessed by the investigator as having high-risk factors, including but not limited to tumor involvement of the brainstem, or uncontrolled epilepsy;
- Participants with concurrent other malignant tumors or a history of other malignant tumors within 5 years prior to randomization (excluding cured basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast, etc.);
- Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
- Known allergy to any component of HMPL-306;
- Administration of uridine diphosphate glucuronosyltransferase (UGT) 1A1 inhibitors or UGT1A3 inhibitors less than 1 week or 5 half-lives (whichever is longer) prior to randomization; administration of strong inducers of CYP3A less than 2 weeks or 5 half-lives (whichever is longer) prior to randomization;
- Presence of diseases or conditions that affect drug absorption;
- Participants will be excluded if there is any other disease, mental abnormality, metabolic abnormality, physical examination abnormality, or laboratory parameter abnormality of significant clinical significance, etc., which, in the investigator's judgment, may affect the participant's compliance, or place the participant at high risk, or affect the interpretation of study results, or if there is reason to suspect that the participant has a disease or condition unsuitable for the use of the study drug.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of HMPL-306 in Participants With Postoperative Residual or Recurrent Grade 2 Glioma Harboring IDH1 or IDH2 Mutations
This study is a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial evaluating the efficacy and safety of HMPL-306 in participants with postoperative residual or recurrent grade 2 gliomas carrying IDH1 or IDH2 mutations.
Read the detailed description
This study plans to enroll approximately 210 participants with postoperative residual or recurrent grade 2 astrocytoma or oligodendroglioma carrying IDH1 or IDH2 mutations who have previously received only surgical treatment.
Participants meeting all enrollment eligibility criteria will be randomized in a 1:1 ratio to receive HMPL-306 250 mg or placebo matched to HMPL-306 administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first.
Participants in the placebo group with BIRC-confirmed PD, after evaluation, may cross over to the HMPL-306 group to receive HMPL-306 treatment.
- Being tested
- HMPL-306 tablet, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMPL-306 tabletDrug
Participants meeting all enrollment eligibility criteria will be randomized in a 1:1 ratio to receive HMPL-306 or placebo matched to HMPL-306 administered orally once daily (QD). Participants in HMPL-306 group will receive HMPL-306 250 mg administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first.
PlaceboDrug
Participants meeting all enrollment eligibility criteria will be randomized in a 1:1 ratio to receive HMPL-306 or placebo matched to HMPL-306 administered orally once daily (QD). Participants in placebo group will receive placebo matched to HMPL-306 administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first.
Participants in the placebo group with BIRC-confirmed PD, after evaluation, may cross over to the HMPL-306 group to receive HMPL-306 treatment.
| Study group | Role | What they receive |
|---|---|---|
| HMPL-306 tablet | Experimental | Participants in HMPL-306 group will receive HMPL-306 250 mg administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first. Receives: Drug: HMPL-306 tablet |
| Placebo | Placebo comparator | Participants in placebo group will receive placebo matched to HMPL-306 administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first.
Participants in the placebo group with BIRC-confirmed PD, after evaluation, may cross over to the HMPL-306 group to receive HMPL-306 treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS assessed by BIRC (according to Response Assessment in Neuro-Oncology [RANO] 2.0 criteria)
PFS(progression-free survival ):The time from the date of randomization to the date of first disease progression (PD) confirmed by BIRC(Blinded Independent Review Committee) or death from any cause
Measured: Up to approximately 30 months
Secondary outcomes (14)
TTNI
TTNI(time to next intervention ):The time from the date of randomization to the date of first initiation of any subsequent anti-tumor therapy or all-cause death
Measured: Up to approximately 36 months
TGR
TGR( tumor growth rate) :The time from the date of randomization to the date of first disease progression (PD) confirmed by BIRC or death from any cause
Measured: every 6months,up to approximately 30 months
TEAEs
Treatment-emergent adverse events (TEAEs) are defined as all adverse medical events that occur after participants receive the investigational medicinal product, which may manifest as symptoms, signs, diseases, or laboratory abnormalities, but are not necessarily causally related to the investigational medicinal product.
Measured: Up to approximately 30 months
PFS assessed by Investigator
PFS ( progression-free survival) : the time from the date of randomization to the date of first PD confirmed by investigators or all-cause death
Measured: Up to approximately 30 months
ORR
ORR(objective response rate),defined as the proportion of participants with best overall response of complete response (CR), partial response (PR), and minor response (MR)
Measured: Up to approximately 30 months
DCR
DCR(disease control rate), defined as the proportion of participants with best overall response of CR(complete response), PR(partial response), MR(minor response), and SD(Stable Disease )
Measured: Up to approximately 30 months
TTR
TTR(the time to response), defined as the time from the date of randomization to the date of first documented CR(complete response), PR(partial response), MR(minor response)
Measured: Up to approximately 30 months
DoR
DoR( duration of response), defined as the time from the date of first documented CR(complete response), PR(partial response), MR(minor response) to the date of first documented PD(Disease Progression) or death
Measured: Up to approximately 30 months
(CR+PR) Rate
CR+PR rate(the proportion of complete response and partial response), defined as the proportion of participants with best overall response of CR(complete response), and PR(partial response)
Measured: Up to approximately 30 months
Time to CR+PR
Time to CR+PR, defined as the time from the date of randomization to the date of first documented CR(complete response), or PR(partial response)
Measured: Up to approximately 30 months
Duration of CR+PR
Duration of CR+PR, defined as the time from the date of first documented CR or PR to the date of first documented PD or death from any cause, whichever occurs first
Measured: Up to approximately 30 months
OS
Overall survival (OS) :the time from the date of randomization to the date of all-cause death
Measured: Up to approximately 30 months
HRQoL (health-related quality of life)assessed by the FACT-Br (Functional Assessment of Cancer Therapy-Brain)questionnaire
The health-related quality of life (HRQoL) will be evaluated using the Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire in participants treated with HMPL-306 versus placebo
Measured: Up to approximately 30 months
PK characteristics(plasma drug concentrations at each sampling time point)
Plasma drug concentrations at each sampling time point
Measured: Up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionMar 2032 (estimated)
- Study completionSep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 MutationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants meeting all enrollment eligibility criteria will be randomized in a 1:1 ratio to receive HMPL-306 250 mg or placebo matched to HMPL-306 administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first. Participants in the placebo group with BIRC-confirmed PD, after evaluation, may cross over to the HMPL-306 group to receive HMPL-306 treatment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hutchmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinsong Wu, MD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912398
- Sponsor's protocol ID
- 2026-306-00CH1
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of HMPL-306 in Participants With Postoperative Residual or Recurrent Grade 2 Glioma Harboring IDH1 or IDH2 Mutations
- ClinicalTrials.gov ID
- NCT07912398
- Acronym / sponsor ID
- 2026-306-00CH1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- HutchmedIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Mar 2032 (estimated)
- Study completion
- Sep 2032 (estimated)
- First posted
- 3 Nov 2026 (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 randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial evaluating the efficacy and safety of HMPL-306 in participants with postoperative residual or recurrent grade 2 gliomas carrying IDH1 or IDH2 mutations.
Detailed description
This study plans to enroll approximately 210 participants with postoperative residual or recurrent grade 2 astrocytoma or oligodendroglioma carrying IDH1 or IDH2 mutations who have previously received only surgical treatment.
Participants meeting all enrollment eligibility criteria will be randomized in a 1:1 ratio to receive HMPL-306 250 mg or placebo matched to HMPL-306 administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first.
Participants in the placebo group with BIRC-confirmed PD, after evaluation, may cross over to the HMPL-306 group to receive HMPL-306 treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants meeting all enrollment eligibility criteria will be randomized in a 1:1 ratio to receive HMPL-306 250 mg or placebo matched to HMPL-306 administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first. Participants in the placebo group with BIRC-confirmed PD, after evaluation, may cross over to the HMPL-306 group to receive HMPL-306 treatment.
| Arm | Type | Receives |
|---|---|---|
| HMPL-306 tablet | Experimental | Drug: HMPL-306 tabletParticipants in HMPL-306 group will receive HMPL-306 250 mg administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants in placebo group will receive placebo matched to HMPL-306 administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first. Participants in the placebo group with BIRC-confirmed PD, after evaluation, may cross over to the HMPL-306 group to receive HMPL-306 treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have fully understood this study and voluntarily signed the ICF, willing to complete the planned visits, treatments, procedures, and laboratory tests during the study period;
- Age ≥18 years old;
- Patients with grade 2 oligodendroglioma or grade 2 astrocytoma;
- Have confirmed presence of IDH1 or IDH2 gene mutation, and obtained chromosome 1p/19q status;
- Have undergone at least 1 glioma surgery and have not received any other anti-glioma treatments, including chemotherapy and radiotherapy;
Key exclusion criteria (8 listed)
- Previously received any other anti-glioma treatment except for surgery, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, or biological therapy, etc.;
- Participants assessed by the investigator as having high-risk factors, including but not limited to tumor involvement of the brainstem, or uncontrolled epilepsy;
- Participants with concurrent other malignant tumors or a history of other malignant tumors within 5 years prior to randomization (excluding cured basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast, etc.);
- Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
- Known allergy to any component of HMPL-306;
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-306 tabletParticipants meeting all enrollment eligibility criteria will be randomized in a 1:1 ratio to receive HMPL-306 or placebo matched to HMPL-306 administered orally once daily (QD). Participants in HMPL-306 group will receive HMPL-306 250 mg administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first. | Drug | HMPL-306 tablet |
| PlaceboParticipants meeting all enrollment eligibility criteria will be randomized in a 1:1 ratio to receive HMPL-306 or placebo matched to HMPL-306 administered orally once daily (QD). Participants in placebo group will receive placebo matched to HMPL-306 administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first. Participants in the placebo group with BIRC-confirmed PD, after evaluation, may cross over to the HMPL-306 group to receive HMPL-306 treatment. | Drug | Placebo |
Primary outcome
PFS assessed by BIRC (according to Response Assessment in Neuro-Oncology [RANO] 2.0 criteria)
Time frame: Up to approximately 30 months
PFS(progression-free survival ):The time from the date of randomization to the date of first disease progression (PD) confirmed by BIRC(Blinded Independent Review Committee) or death from any cause
14 secondary outcomes
TTNI
Time frame: Up to approximately 36 months
TGR
Time frame: every 6months,up to approximately 30 months
TEAEs
Time frame: Up to approximately 30 months
PFS assessed by Investigator
Time frame: Up to approximately 30 months
ORR
Time frame: Up to approximately 30 months
DCR
Time frame: Up to approximately 30 months
TTR
Time frame: Up to approximately 30 months
DoR
Time frame: Up to approximately 30 months
(CR+PR) Rate
Time frame: Up to approximately 30 months
Time to CR+PR
Time frame: Up to approximately 30 months
Duration of CR+PR
Time frame: Up to approximately 30 months
OS
Time frame: Up to approximately 30 months
HRQoL (health-related quality of life)assessed by the FACT-Br (Functional Assessment of Cancer Therapy-Brain)questionnaire
Time frame: Up to approximately 30 months
PK characteristics(plasma drug concentrations at each sampling time point)
Time frame: Up to approximately 6 months
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 3 Nov 2026.
- Individual participant dataSharing planned: No
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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, MD principal investigator
Huashan Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HMPL-306 tablet in people with Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation, run by Hutchmed.
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 9 inclusion and 8 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Lu Chen (021 -2067 3000 - 5014, Luc@hutch-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS assessed by BIRC (according to Response Assessment in Neuro-Oncology [RANO] 2.0 criteria) (time frame: Up to approximately 30 months). 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 3 Nov 2026.