Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07025018 | Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and/or IDH2 Mutations | PHASE1 | RECRUITING | 52 | — | — | Jul 15, 2025 | Dec 1, 2027 | Aug 1, 2025 | 1 | China |
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...