Study of the ZN-d5 and ZN-c3 in Subjects With Acute Myeloid Leukemia (AML)

A Phase 1/2 dose escalation study of BCL-2 Inhibitor ZN-d5 and the Wee1 Inhibitor ZN-c3 in Subjects with Acute Myeloid Leukemia (AML).

Inclusion Criteria:Adults with AML (including secondary or therapy-related), relapsed from or refractory to one or more prior lines of therapy, which may include venetoclax except in Expansion Cohort AECOG performance status score ≤2.Projected life expectancy of at least 12 weeks.Estimated glomerular filtration rate ≥60 mL/minWomen of childbearing potential must not be pregnant and must use effective birth control during the study and for 6 months after the last dose of study drugs.Men must agree to use a condom when having intercourse during the study and for 3 months after the last dose of study drugs.Exclusion Criteria:Known active CNS involvementDiagnosis of acute promyelocytic leukemia.Peripheral blast count of >25 × 109/L (cytoreduction permitted).Adequate washout from prior therapy including hematopoietic stem cell transplant and recovery from prior treatment-related toxicities to Grade 2 or lowerSignificant cardiovascular diseaseCorrected QT interval (QTc) of >480 msecActive hepatitis B or hepatitis C infectionConcurrent treatment with strong CYP3A inhibitors or strong or moderate CYP3A inducers