Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:04 AM
Study NCT ID:
NCT07025018
Status:
RECRUITING
Last Update Posted:
2025-08-01
First Post:
2025-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and/or IDH2 Mutations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2025-05-28', 'studyFirstSubmitQcDate': '2025-06-09', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'From first dose of study drug to the time of progressive disease, assessed up to 24 months on average', 'description': 'ORR is defined as the proportion of subjects with confirmed best overall tumor response of Complete Response (CR) or Partial Response (PR) or Minor Response (MR).'}, {'measure': 'Duration of response (DoR)', 'timeFrame': 'From first dose of study drug to the time of disease relapse or death, whichever comes first, assessed up to 24 months on average', 'description': 'DoR defined as the time from the date of the first CR or PR or MR to the first date of progressive disease (PD) or death from any cause.'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'From first dose of study drug to the time of progressive disease or death due to any causes, whichever comes first, assessed up to 24 months', 'description': 'PFS is defined as time from first dose date of study drug to date of progression or date of death from any cause, whichever occurred first.'}], 'primaryOutcomes': [{'measure': 'Number of Subjects with Dose Limiting Toxicities (DLTs)', 'timeFrame': 'Up to 28 days after first dose of study drug', 'description': '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.'}, {'measure': 'RP2D', 'timeFrame': 'From first dose of study drug to the time of progressive disease, assessed up to 24 months on average', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Maximum serum drug concentration', 'timeFrame': 'PK/PD weeks at screening through safety follow-up, assessed up to 24 months on average', 'description': 'Blood samples will be obtained from all patients for determination of the maximum serum concentration of HMPL-306.'}, {'measure': 'Time to maximum concentration', 'timeFrame': 'PK/PD weeks at screening through safety follow-up, assessed up to 24 months on average', 'description': 'Blood samples will be obtained from all patients for determination time to maximum concentration of HMPL-306.'}, {'measure': 'Area under the concentration-time curve (AUC)', 'timeFrame': 'PK/PD weeks at screening through safety follow-up, assessed up to 24 months on average', 'description': 'Blood samples will be obtained from all patients for determination of the AUC of HMPL-306'}, {'measure': 'Concentration of 2-HG in brain tumor tissue', 'timeFrame': 'PK/PD weeks at screening through safety follow-up, assessed up to 24 months on average', 'description': 'Brain tumor tissue will be obtained from suitable patients for determination concentration of 2-HG.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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'], 'conditions': ['Gliomas Harboring IDH1 and/or IDH2 Mutations']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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/or IDH2 mutation. Perioperative Study Phase: Patients with gliomas of definitive or suspected IDH1 and/or 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."}, 'identificationModule': {'nctId': 'NCT07025018', 'briefTitle': 'Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and/or IDH2 Mutations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hutchmed'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2025-306-00CH1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Safety run-in', 'description': '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.', 'interventionNames': ['Drug: HMPL-306']}, {'type': 'EXPERIMENTAL', 'label': 'Perioperative study phase', 'description': '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.', 'interventionNames': ['Drug: HMPL-306']}], 'interventions': [{'name': 'HMPL-306', 'type': 'DRUG', 'description': 'IDH small molecule inhibitor', 'armGroupLabels': ['Perioperative study phase', 'Safety run-in']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuai Wu', 'role': 'CONTACT', 'email': 'wushuai0606@126.com', 'phone': '15316051226'}], 'facility': 'Huashan Hospital affiliated to Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Tinghua Song', 'role': 'CONTACT', 'email': 'tinghuas@hutch-med.com', 'phone': '+86 21 2067 1822'}], 'overallOfficials': [{'name': 'Jinsong Wu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huashan Hospital'}, {'name': 'Bo Zhang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hutchmed'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hutchmed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}