Acute Myeloid Leukemia Clinical Trial

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

Summary

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).

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Full Description

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.

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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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

95

Study ID:

NCT05682170

Recruitment Status:

Recruiting

Sponsor:

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

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There are 3 Locations for this study

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Investigative Site 0108
Birmingham Alabama, 35233, United States
Site 0266
San Francisco California, 94110, United States
Site 0105
New York New York, 10065, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

95

Study ID:

NCT05682170

Recruitment Status:

Recruiting

Sponsor:


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

How clear is this clinincal trial information?

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