A Study of HMPL-306 in Patients With IDH1 and/or IDH2 Mutation of Relapsed/Refractory Myeloid Leukemia/Neoplasms

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hutchison Medipharma Limited

Criteria

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.