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

Stopped early · Phase 1/Phase 2

Conditions studied: Acute Myeloid Leukemia (AML)

In brief

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).

Key facts

Study ID

NCT05682170

Run by

K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.

People needed

40

Starts

2022-12-01

Expected to finish

2024-07-26

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California San Francisco — San Francisco, California, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• NYU Langone Health — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Albert Einstein College of Medicine - Montefiore Medical Center — The Bronx, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• James Cancer Hospital and Solove Research Institute — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Tristar Bone Marrow Transplant — Nashville, Tennessee, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• The Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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