Clinical trial · Interventional
A Study of HMPL-306 in Patients With IDH1 and/or IDH2 Mutation of Relapsed/Refractory Myeloid Leukemia/Neoplasms
A Phase I, Open-Label, Multicenter Study to Assess the Safety, Pharmacokinetics and Efficacy of HMPL-306 in Patients of Relapsed/Refractory Myeloid Leukemia/Neoplasms With IDH1 and/or IDH2 Mutation
NCT04272957CI-TRIAL-00045567unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase I, multicenter study to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of HMPL-306 in Patients of Relapsed/Refractory Myeloid Leukemia/Neoplasms with IDH1 and/or IDH2 Mutation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HMPL-306 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HMPL-306
- description
- HMPL-306 administered continuously as a single agent orally every day in a 28-day cycle.
- interventionNames
- Drug: HMPL-306
Primary outcomes (2)
- measure
- Safety and tolerability: Incidence of adverse events
- timeFrame
- Baseline up to the last patient has completed the 24 weeks of treatment
- description
- Incidence of adverse events.
- measure
- Maximum tolerated dosage (MTD) and/or recommended phase 2 dosage (RP2D)
- timeFrame
- Baseline up to the last patient has completed the 24 weeks of treatment
- description
- Measured by adverse event profile.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥18 years of age; * Signed Informed Consent Form; * Relapsed/refractory Acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia(CMML) and others myeloid neoplasm; * IDH1 and/or IDH2 mutated disease status as assessed by local laboratory; * Cooperative Oncology Group (ECOG) performance status of 0-2; * Subjects must be amenable to serial bone marrow biopsies, peripheral blood sampling, and urine sampling during the study. Exclusion Criteria: * Previously treated with any prior IDH1 inhibitor, IDH2 inhibitor, or IDH1/IDH2 double-targeted therapy and had disease progression during treatment; * with known involvement or clinical symptoms of central nervous system (CNS); * Patients who have undergone HSCT within 60 days; * Without adequate liver or kidney function; * With known infection with active hepatitis B or C; * With known infection with human immunodeficiency virus (HIV); * History of clinically significant or active cardiac disease; * Active clinically significant infection; * Taking known strong cytochrome P450 (CYP) 2C8 inducers or inhibitors; * Pregnancy or breast-feeding.
References
Publications (1)
- DERIVEDHu L, Wei X, Zhao W, Hu Y, Li J, Dong Y, Gong T, Zhang X, Xu Y, Zhang Y, Xu C, Zhang C, Cai Z, Jing H, Mi R, Wu W, He W, Wang H, Tang Q, Jiang Z, Liu H, Chen G, Sun J, Chen J, Yan S, Yan H, Wangwu J, Zhong Z, Wang L, Fan S, Shi M, Su W, Huang X. HMPL-306 in relapsed or refractory IDH1- and/or IDH2-mutated acute myeloid leukemia: A phase 1 study. Med. 2025 Jun 13;6(6):100575. doi: 10.1016/j.medj.2025.100575. Epub 2025 Jan 31. PMID 39892383