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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.
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.
Safety and tolerability: Incidence of adverse events
Peking University People's Hospital
China, Beijing, Beijing
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