A Phase 1/2, Multicenter, First-in-Human, Dose Escalation and Expansion Study Evaluating CHM-029 as Monotherapy in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) With NPM1 Mutations, KMT2A or NUP98 Rearrangements

Study Identifier:
CHM-029-01
CT.gov Identifier:
NCT07751991
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
N/A
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: CHM-029 Backfill
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Drug: Participants will receive CHM-029 orally at a dose level already evaluated by the Safety Review Committee (SRC).
Drug: Drug: CHM-029
Drug: CHM-029 is administered orally.
Drug: EXPERIMENTAL: CHM-029 Dose Escalation
Drug: Participants will receive CHM-029 orally. Dose levels will be escalated based on dose limiting toxicities (DLTs) as evaluated by the Safety Review Committee (SRC).
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
Inclusion criteria
  • * 18 years old and above
  • * Relapsed or refractory (R/R) acute myeloid leukemia (AML) and has had treatment with any available standard therapies
  • * Positive for NPM1 mutation, or KMT2A or NUP98 rearrangements
Exclusion criteria
  • White blood cell (WBC) count higher than 25,000 u/L that cannot be maintained below threshold with hydroxyurea treatment
  • * Extramedullary only AML
  • * Has current complications related to hematopoietic stem cell transplant (HSCT)
  • * Other cancers that require treatment
  • * Active Hepatitis or HIV infection
  • * Moderate hepatic or renal impairment
  • * Acute promyelocytic leukemia
  • * Baseline prolongation of QT/QTc interval (≥ 470 ms) or additional risk factors for Torsades de Pointes (TdP)
  • * Congestive heart failure NYHA Class 3 or 4
  • * Central nervous system involvement refractory to intrathecal chemotherapy and/or standard cranial-spinal radiation

Clinical Study Information for Healthcare Providers

By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Andrew Sochacki
Status
Recruiting
Condition(s) Treated at Site