NCT07025018 Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and/or IDH2 Mutations
| NCT ID | NCT07025018 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hutchmed |
| Condition | Gliomas Harboring IDH1 and/or IDH2 Mutations |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2025-07-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 52 participants in total. It began in 2025-07-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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.
Contact & Investigator
Jinsong Wu
PRINCIPAL INVESTIGATOR
Huashan Hospital
Frequently Asked Questions
Who can join the NCT07025018 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gliomas Harboring IDH1 and/or IDH2 Mutations. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07025018 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07025018 currently recruiting?
Yes, NCT07025018 is actively recruiting participants. Contact the research team at tinghuas@hutch-med.com for enrollment information.
Where is the NCT07025018 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07025018 clinical trial?
NCT07025018 is sponsored by Hutchmed. The principal investigator is Jinsong Wu at Huashan Hospital. The trial plans to enroll 52 participants.