[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594866":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":33,"locations":39,"responsibleParty":59,"collaborators":24,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":24,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":24,"enrollmentInfo":70,"targetDuration":24,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Hutchmed","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Safety run-in","EXPERIMENTAL","This phase plans to enroll patients with gliomas of IDH1 and\u002For IDH2 mutations. The DLT will be evaluated during the first 28 days after the initial dosage.",[13],"Drug: HMPL-306",{"label":15,"type":10,"description":16,"interventionNames":17},"Perioperative study phase","This phase plans to enroll patients with gliomas of definitive or suspected IDH1 and\u002For 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.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","HMPL-306","IDH small molecule inhibitor",[15,9],null,[26,30],{"name":27,"affiliation":28,"role":29},"Jinsong Wu","Huashan Hospital","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":5,"role":32},"Bo Zhang","STUDY_DIRECTOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Tinghua Song","CONTACT","+86 21 2067 1822","tinghuas@hutch-med.com",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Huashan Hospital affiliated to Fudan University","RECRUITING","Shanghai","Shanghai Municipality","200040","China","CN",{"type":49,"coordinates":50},"Point",[51,52],121.45806,31.22222,{"lat":52,"lon":51},[55],{"name":56,"role":36,"phone":57,"phoneExt":24,"email":58},"Shuai Wu","15316051226","wushuai0606@126.com",{"type":60,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100594866","phase-1-phase-i-study-of-hmpl-306-for-the-treatment-of-gliomas-with-idh1-andor-idh2-mutations-100594866",false,"NCT07025018","Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and\u002For IDH2 Mutations","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\u002For IDH2 Mutations","Inclusion Criteria:\n\n1. Fully informed about the study and voluntarily sign the informed consent form (ICF).\n2. Age ≥ 18 years.\n3. Safety Lead-In Phase: Patients with gliomas of a documented IDH1 and\u002For IDH2 mutation. Perioperative Study Phase: Patients with gliomas of definitive or suspected IDH1 and\u002For IDH2 mutations scheduled for surgery.\n4. All patients must have at least one measurable lesion.\n5. Karnofsky Performance Status (KPS) score ≥ 80% .\n6. In the investigator's judgment, a life expectancy of ≥ 12 weeks.\n7. Sufficient bone marrow and organ function.\n\nExclusion Criteria:\n\n1. Previous treatment with IDH inhibitors.\n2. Unresolved toxicity from previous antitumor treatments not reverted to ≤ Grade 1 (except for alopecia, skin pigmentation changes, and ≤ Grade 2 peripheral neuropathy).\n3. Patients assessed by researchers to have high-risk or unstable conditions.\n4. Having other malignancies or a history of other malignancies within 5 years prior to screening.\n5. History of clinically significant liver disease, including active infection with viral hepatitis, or other active hepatitis, alcoholic liver disease, cirrhosis, etc.\n6. Patients with HIV infection.\n7. Pregnancy (positive pregnancy test before dosing) or currently breastfeeding women.\n8. Presence of diseases or conditions affecting drug absorption.\n9. Any other conditions, in the investigator's judgment, unsuitable for the study drug, will result in exclusion.","ALL","18 Years",{"count":71,"type":72},52,"ESTIMATED","INTERVENTIONAL",[75],"PHASE1","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\u002For IDH2 mutations",[78],"Gliomas Harboring IDH1 and\u002For IDH2 Mutations",[80,81,82,83,84,85,86,87,88,89,90,91,21,92],"gliomas","randomized controlled","Multicenter","IDH1 mutations","IDH2 mutations","safety run-in","MRI\u002FMRS examination","Phase I","clinical study","pharmacokinetics (PK)","pharmacodynamics (PD)","efficacy","perioperative study","2025-07-31",{"date":95,"type":96},"2025-08-01","ACTUAL",{"date":98,"type":96},"2025-07-15",{"date":100,"type":72},"2027-12",{"name":5,"class":6},1]