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

K-Group Alpha

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Acute Myeloid Leukemia (AML)

Treatments

Drug: ZN-c3

Drug: ZN-d5 ZN-c3

Study type

Interventional

Funder types

Industry

Identifiers

NCT05682170

ZN-d5-004C

Details and patient eligibility

About

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).

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.

Enrollment

95 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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