A Phase 1/2 Dose Escalation Study of the BCL-2 Inhibitor ZN-d5 and the WEE1 Inhibitor ZN-c3 in Subjects With Acute Myeloid Leukemia

Description

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).This is an open-label multicenter Phase 1/2 dose escalation study, evaluating the safety, tolerability, clinical activity, pharmacokinetics and pharmacodynamics of the novel BCL-2 inhibitor ZN-d5 and Wee1 inhibitor ZN-c3 in subjects with AML.

Trial Eligibility

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 A * ECOG performance status score ≤2. * Projected life expectancy of at least 12 weeks. * Estimated glomerular filtration rate ≥60 mL/min * Women 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 involvement * Diagnosis 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 lower * Significant cardiovascular disease * Corrected QT interval (QTc) of \>480 msec * Active hepatitis B or hepatitis C infection * Concurrent treatment with strong CYP3A inhibitors or strong or moderate CYP3A inducers

Study Info

Interventions

Locations Recruiting

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