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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
Organization
K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
Primary Outcome
Observed dose limiting toxicities
Interventions
Locations Recruiting
University of Alabama at Birmingham
United States, Alabama, Birmingham
University of California San Francisco
United States, California, San Francisco
Dana Farber Cancer Institute
United States, Massachusetts, Boston
University of Minnesota
United States, Minnesota, Minneapolis
Albert Einstein College of Medicine - Montefiore Medical Center
United States, New York, Bronx
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