Study on ZN-d5 and ZN-c3 for Patients 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

Provider View

This clinical trial is testing two new drugs, ZN-d5 and ZN-c3, to see if they are safe and effective for treating patients with Acute Myeloid Leukemia (AML).

Patient Parameters

Program Overview

This study is in its early stages (Phase 1/2) and aims to find the right dose of two new drugs, ZN-d5 and ZN-c3, for patients with Acute Myeloid Leukemia (AML). The study will look at how safe these drugs are, how well patients can tolerate them, and how they affect the body and the cancer.

Description

This clinical trial is open to patients with Acute Myeloid Leukemia (AML) who have not responded to previous treatments or whose cancer has returned. The study will take place at multiple centers and will test different doses of two new drugs, ZN-d5 and ZN-c3, to find the safest and most effective dose. Researchers will monitor patients closely to see how their bodies respond to the treatment and to check for any side effects. The study will also gather information on how the drugs move through the body and how they affect the cancer cells.

Eligibility Criteria

Inclusion Criteria

  • Adults diagnosed with Acute Myeloid Leukemia (AML), including those whose cancer has returned or did not respond to previous treatments.
  • Must have a performance status score of 2 or lower, meaning they are able to carry out all self-care but unable to carry out any work activities.
  • Expected to live for at least 12 more weeks.
  • Must have good kidney function, with a filtration rate of 60 mL/min or higher.
  • Women who can become pregnant must not be pregnant and must use effective birth control during the study and for 6 months after the last dose.
  • Men must agree to use a condom during intercourse while in the study and for 3 months after the last dose.

Exclusion Criteria

  • Active cancer involvement in the central nervous system (CNS).
  • Diagnosis of a specific type of leukemia called acute promyelocytic leukemia.
  • High number of cancer cells in the blood, but treatment to reduce this is allowed.
  • Must have recovered from previous treatments, including stem cell transplants, to a certain level.
  • Significant heart disease.
  • Heart rhythm issues with a QT interval over 480 milliseconds.
  • Active hepatitis B or C infections.
  • Cannot be taking certain medications that strongly affect liver enzymes.

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