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

  • STATUS
    Recruiting
  • participants needed
    75
  • sponsor
    Hutchison Medipharma Limited
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Updated on 16 February 2024
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myeloid leukemia
myelodysplastic syndromes
leukemia
chronic myelomonocytic leukemia
refractory acute myeloid leukemia (aml)
myeloid neoplasm
idh2 gene mutation
IDH2

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.

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.

Details
Condition Acute myeloid leukemia, Acute myeloid leukemia
Age 18years - 100years
Treatment HMPL-306
Clinical Study IdentifierNCT04272957
SponsorHutchison Medipharma Limited
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
Clear my responses
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myeloid leukemia
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chronic myelomonocytic leukemia
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myeloid neoplasm
idh2 gene mutation
IDH2

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