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

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

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05682170

Patient View

This Phase 1/2 open-label, multicenter study assesses the safety, tolerability, and clinical activity of the BCL-2 inhibitor ZN-d5 and Wee1 inhibitor ZN-c3 in adults with relapsed or refractory AML. Eligible participants must have an ECOG score ≤2 and a life expectancy of at least 12 weeks. The study involves oral administration of ZN-d5 and ZN-c3, with specific contraceptive requirements for participants.

Patient Parameters

Program Overview

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).

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.

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

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