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

• Status: Recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.

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