Study of the ZN-d5 and ZN-c3 in Subjects With Acute Myeloid Leukemia (AML)
Purpose
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).
Condition
- Acute Myeloid Leukemia (AML)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Acute Myeloid Leukemia |
Phase 1: Dose Escalation- c3 monotherapy and d5+c3 combination Phase 2: Dose Expansion |
|
Recruiting Locations
University of Alabama at Birmingham
Birmingham, Alabama 35233
Birmingham, Alabama 35233
More Details
- Status
- Recruiting
- Sponsor
- K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
Study Contact
K-Group Alpha, Inc. a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.medicalaffairs@zentalis.com
Detailed 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.