Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

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).

Official Title

A Phase 1/2 Dose Escalation Study of the BCL-2 Inhibitor ZN-d5 and the WEE1 Inhibitor ZN-c3 in Subjects With Acute Myeloid Leukemia

Details

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.

Keywords

Acute Myeloid Leukemia (AML), BCL-2 Inhibitors, Wee1 Inhibitors, AML, Leukemia, Myeloid Leukemia, Leukemia, Myeloid, Acute, Acute Myeloid Leukemia

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94110 United States
  • University of Texas MD Anderson Cancer Center accepting new patients
    Houston Texas 77030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
ID
NCT05682170
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 95 study participants
Last Updated