A Study of HMPL-306 in Patients With IDH1 and/or IDH2 Mutation of Relapsed/Refractory Myeloid Leu… (NCT04272957) | Clinical Trial Compass
UnknownPhase 1
A Study of HMPL-306 in Patients With IDH1 and/or IDH2 Mutation of Relapsed/Refractory Myeloid Leukemia/Neoplasms
China75 participantsStarted 2020-05-14
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Safety and tolerability: Incidence of adverse events
Timeframe: Baseline up to the last patient has completed the 24 weeks of treatment
2
Maximum tolerated dosage (MTD) and/or recommended phase 2 dosage (RP2D)
Timeframe: Baseline up to the last patient has completed the 24 weeks of treatment