A Phase I Study of ZN-c3 and ZN-d5 in People with Recurrent or Persistent Acute Myeloid Leukemia

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Full 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

Purpose

The purpose of this study is to find the highest dose of the investigational drug ZN-c3 that can be given alone or with the drug ZN-d5 in people with acute myeloid leukemia (AML) that came back or continued to grow despite prior treatment. ZN-c3 targets and blocks WEE1 kinase, a protein that plays an important role in helping cancer cells repair damaged DNA. ZN-d5 targets and inhibits the activity of BCL-2, a protein that contributes to cancer cell growth.

Participants in this study will receive ZN-c3 alone or with ZN-d5. Both medications are taken orally (by mouth).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have AML that came back or continued to grow despite treatment.
  • The serious side effects of previous therapies must go away before the study treatment is given.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

Contact

For more information about this study and to ask about eligibility, please contact the office of Dr. Raajit Rampal at 646-608-3746.

Protocol

22-332

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05682170