HealthTree Logo
search more_vert
person Sign In / Create Account

Go back to trials list

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


The purpose of this Phase I, multicenter study is 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. The first stage of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of HMPL-306 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second stage of the study is a dose expansion phase where three cohorts of patients will receive HMPL-306 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose.

Trial Eligibility

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.

Study Info



Primary Outcome

Safety and tolerability: Incidence of adverse events

Outcome Timeframe Baseline up to the last patient has completed the 24 weeks of treatment

NCTID NCT04272957

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2020-05-14

Completion Date 2021-06-30

Enrollment Target 75



Locations Recruiting

Peking University People's Hospital

China, Beijing, Beijing

Interested in joining this trial?

Our dedicated patient navigators are here to guide you through the validation and enrollment process with ease.

Get the latest thought leadership on Acute Myeloid Leukemia delivered straight to your inbox.

Subscribe to the weekly "HealthTree Community for Acute Myeloid Leukemia Newsletter" for Acute Myeloid Leukemia news, life with Acute Myeloid Leukemia stories, Acute Myeloid Leukemia clinical trials, Acute Myeloid Leukemia 101 articles and events with Acute Myeloid Leukemia experts.

Thanks to our HealthTree Community for Acute Myeloid Leukemia Sponsors:

Astellas Pharma

Follow Us

facebook twitter