A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML

Condition(s) studied

Investigational drug(s) / intervention(s)

CHM-029: oral

Study summary

The goal of this study is to evaluate the safety of CHM-029, an investigational oral medicine, and to evaluate its activity in treating certain types of acute myeloid leukemia (AML) in adults. The main questions the study aims to answer are:

* What is an appropriate dose of CHM-029?
* What side effects may occur with CHM-029?
* How does the body process CHM-029?

Researchers will evaluate increasing dose levels of CHM-029 to better understand its safety and how the body responds to treatment.

Participants will visit the study clinic regularly for safety assessments, blood tests, electrocardiograms (ECGs), and bone marrow evaluations to monitor their health and response to treatment.

Eligibility

Primary outcome measure(s)

• Number of participants with dose limiting toxicities (DLTs) — Baseline through Day 28
  A DLT is defined as any Adverse Event (AE) which meets DLT criteria, not clearly due to the underlying disease or extraneous causes, that occurs within the DLT observation period.
• Number of participants with adverse events (AEs) — Baseline through study completion, an average of 3 years
  An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
• Number of participants with adverse events (AEs) by severity — Baseline through study completion, an average of 3 years
  Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0
• Number of participants with laboratory value abnormalities and/or adverse events (AEs) — Baseline through study completion, an average of 3 years
  Number of participants with potentially clinically significant laboratory values.
• Rates of dose modification due to adverse events (AEs) according to NCI CTCAE — Baseline through study completion, an average of 3 years
  Safety and tolerability will be evaluated by dose interruption, modification, and discontinuation due to adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.6.0
• Maximum tolerated dose (MTD) and/or optimal biological dose (OBD) of CHM-029 — Baseline through study completion, an average of 3 years
  Maximum tolerated dose or optimal biological dose will be determined by the sponsor based on the Safety Review Committee's recommendation considering the totality of the available clinical safety, clinical efficacy, pharmacokinetics (PK), and pharmacodynamic data

Trial sites (4)