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Also known as HMPL-306 Regimen
HMPL-306 · 2 trials · 2 indications
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| HMPL-306 Regimen | DRUG | Patients will receive HMPL-306 monotherapy: HMPL-306 PO at 250 mg QD (C1) + 150 mg QD (starting from C2), 28 days as a cycle. |
| Salvage Chemotherapy Regimen | DRUG | Patients in this regimen will receive treatment with one of the following regimens, and the regimen will be selected by the investigator based on the patient's condition: * EA±Mitox regimen: etoposide injection 100 mg/m2, cytarabine injection 100-150 mg/m2, mitoxantrone injection 8 mg/m2 QD IV for 5 consecutive days (Days 1-5). * FLAG ± Ida regimen: G-CSF injection 300 mcg/m2 QD SC for 5 consecutive days (Days 1-5); fludarabine injection 30 mg/m2 QD IV for 5 consecutive days (Days 2-6); cytarabine injection 1000-2000 mg/m2 QD IV for 5 consecutive days (Days 2-6); idarubicin injection 10 mg/m2 QD IV for 3 consecutive days (Days 2-4). * LoDAC: -Cytarabine Injection 20 mg every 12 hours, subcutaneous or IV for 10 consecutive days (Days 1-10). * Azacitidine: Azacitidine Injection 75 mg/m2, QD, subcutaneous or IV for 7 consecutive days (Days 1-7). |
| HMPL-306 | DRUG | IDH small molecule inhibitor |
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 a...
HMPL-306 is an investigational small molecule developed by HUTCHMED (China) Limited for cancers that carry mutations in the IDH1 and/or IDH2 genes. It is being studied in acute myeloid leukemia and in gliomas harboring IDH1 and/or IDH2 mutations. It is a Phase 3-stage asset and has not been approved for any indication.
HMPL-306 is being evaluated for the treatment of acute myeloid leukemia in patients whose disease carries IDH1 or IDH2 mutations. This is a biomarker-selected population, meaning treatment is directed at tumors with these specific mutations. The program is currently in Phase 3 clinical development and is not approved for use.
HMPL-306 targets the IDH1 and IDH2 enzymes, which are mutated in certain cancers including acute myeloid leukemia and gliomas. By acting on both IDH1 and IDH2, the small molecule is designed to address tumors driven by mutations in either of these two enzymes.
HMPL-306 is developed by HUTCHMED (China) Limited, which trades under the ticker HCM. HUTCHMED is the sponsor of the clinical program evaluating the drug in IDH1 and/or IDH2-mutated acute myeloid leukemia and gliomas.
HMPL-306 is in Phase 3 clinical development. The Phase 3 study is evaluating the drug in patients with IDH1 or IDH2-mutated acute myeloid leukemia, and a separate Phase 1 study is evaluating it in gliomas with IDH1 and/or IDH2 mutations. HMPL-306 is investigational and has not been approved.
HMPL-306 is being studied in two recruiting trials. NCT06387069 is a Phase 3 study of HMPL-306 in patients with IDH1 or IDH2-mutated acute myeloid leukemia, with planned enrollment of 316 patients. NCT07025018 is a Phase 1 study in gliomas harboring IDH1 and/or IDH2 mutations, with planned enrollment of 52 patients in China.
Yes. HMPL-306 Regimen is another name used for HMPL-306, the investigational small molecule developed by HUTCHMED (China) Limited. Both names refer to the same IDH1 and IDH2-targeted agent being studied in acute myeloid leukemia and IDH-mutant gliomas.