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

HUTCHMED

Status and phase

Unknown

Phase 1

Conditions

Acute Myeloid Leukemia

Treatments

Drug: HMPL-306

Study type

Interventional

Funder types

Industry

Identifiers

NCT04272957

2018-306-00CH1

Details and patient eligibility

About

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.

Full description

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.

Enrollment

75 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.