Study of the ZN-d5 and ZN-c3 in Subjects With Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia (AML)
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia (AML) focused on measuring BCL-2 Inhibitors, Wee1 Inhibitors, AML
Eligibility Criteria
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
Sites / Locations
- University of Alabama at BirminghamRecruiting
- University of California San FranciscoRecruiting
- Dana Farber Cancer InstituteRecruiting
- NYU Langone HealthRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- James Cancer Hospital and Solove Research InstituteRecruiting
- University of Texas MD Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Experimental
Acute Myeloid Leukemia
Phase 1: Dose Escalation- c3 monotherapy and d5+c3 combination Phase 2: Dose Expansion