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

K

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

95 participants in 1 patient group

Acute Myeloid Leukemia
Experimental group
Description:
Phase 1: Dose Escalation- c3 monotherapy and d5+c3 combination Phase 2: Dose Expansion
Treatment:
Drug: ZN-d5 ZN-c3
Drug: ZN-c3

Trial contacts and locations

13

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Central trial contact

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

Data sourced from clinicaltrials.gov

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