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 13 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35233, United States More Info
Pankit Vachhani, MD
Contact
205-975-7850
[email protected]
University of California San Francisco
San Francisco California, 94110, United States More Info
Catherine Smith, MD
Contact
415-353-2421
[email protected]
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Eric Winer, MD
Contact
877-442-3324
[email protected]
University of Minnesota
Minneapolis Minnesota, 53792, United States More Info
Mark Juckett, MD
Contact
612-676-4200
[email protected]
Albert Einstein College of Medicine - Montefiore Medical Center
Bronx New York, 10467, United States More Info
Ioannis Mantzaris, MD
Contact
718-920-4826
[email protected]
NYU Langone Health
New York New York, 10016, United States More Info
Mohammad Abdul Hay, MD
Contact
646-501-4818
[email protected]
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Raajit Rampal, MD
Contact
212-639-2194
[email protected]
University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27514, United States More Info
Joshua Zeidner, MD
Contact
919-966-4432
[email protected]
James Cancer Hospital and Solove Research Institute
Columbus Ohio, 43210, United States More Info
Grieselhuber Grieselhuber, MD
Contact
614-366-1164
[email protected]
Oregon Health and Science University
Portland Oregon, 97239, United States More Info
Ronan Swords, MD
Contact
503-494-9014
[email protected]
Tristar Bone Marrow Transplant
Nashville Tennessee, 37203, United States More Info
Stephen Strickland, MD
Contact
615-329-7274
[email protected]
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Guillermo Garcia-Manero, MD
Contact
713-745-3428
[email protected]
The Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Guru Subramanian Guru Murthy, MD
Contact
414-805-8900
[email protected]

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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