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Also known as HMPL-306 Regimen
HMPL-306 · 1 trial · 1 indication
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 | 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 being studied for the treatment of gliomas harboring IDH1 and/or IDH2 mutations. It is currently in Phase 1 clinical development, with an active trial recruiting patients in China. The drug is not yet approved and remains under investigation for this indication.
HMPL-306 targets IDH1 and IDH2, which are enzymes involved in cellular metabolism. By inhibiting these mutant enzymes, the drug aims to address gliomas that harbor IDH1 and/or IDH2 mutations. This targeted approach is being evaluated in an ongoing Phase 1 clinical trial.
HMPL-306 is being developed by HUTCHMED (China) Limited, a biopharmaceutical company listed on the stock exchange under the ticker HCM. The company is conducting a Phase 1 clinical trial of HMPL-306 for the treatment of gliomas with IDH1 and/or IDH2 mutations.
HMPL-306 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting participants to evaluate the drug's safety and efficacy in patients with gliomas harboring IDH1 and/or IDH2 mutations.
HMPL-306 is being studied in a Phase 1 clinical trial registered as NCT07025018, titled 'Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and/or IDH2 Mutations'. This trial is recruiting 52 participants in China, with an age minimum of 18 years, and is open to all sexes.
Yes, HMPL-306 is also known as HMPL-306 Regimen. Both names refer to the same investigational drug being developed by HUTCHMED (China) Limited for the treatment of gliomas harboring IDH1 and/or IDH2 mutations. The drug is currently in Phase 1 clinical trials.