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Recruiting NCT07751991

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

Phase I Interventional AML (Acute Myeloid Leukemia)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CHM-029.
Who it may be relevant to
Registry conditions: AML (Acute Myeloid Leukemia). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

CHM-029-01 is a Phase 1/2, first-in-human, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antileukemic activity of orally administered CHM-029 in adults with relapsed or refractory acute myeloid leukemia (AML) with an NPM1 mutation, KMT2A rearrangement, or NUP98 rearrangement.

Interventions

  • Drug CHM-029
    CHM-029 is administered orally.

Primary outcome measures

  • Number of participants with dose limiting toxicities (DLTs) [Time frame: Baseline through Day 28]
  • Number of participants with adverse events (AEs) [Time frame: Baseline through study completion, an average of 3 years]
  • Number of participants with adverse events (AEs) by severity [Time frame: Baseline through study completion, an average of 3 years]
  • Number of participants with laboratory value abnormalities and/or adverse events (AEs) [Time frame: Baseline through study completion, an average of 3 years]
  • Rates of dose modification due to adverse events (AEs) according to NCI CTCAE [Time frame: Baseline through study completion, an average of 3 years]
  • Maximum tolerated dose (MTD) and/or optimal biological dose (OBD) of CHM-029 [Time frame: Baseline through study completion, an average of 3 years]
Secondary outcome measures (10)
  • Pharmacokinetics (PK) profile of CHM-029: Plasma concentrations [Time frame: Baseline through study completion, an average of 3 years]
  • Pharmacokinetic (PK) profile of CHM-029: Area under the curve [Time frame: Baseline through study completion, an average of 3 years]
  • Pharmacokinetic (PK) profile of CHM-029: Time of maximum concentration (Tmax) and half-life (T1/2) [Time frame: Baseline through study completion, an average of 3 years]
  • Complete remission and complete remission with partial hematological recovery (CR/CRh) rate [Time frame: Baseline to study completion, an average of 3 years]
  • Composite complete remission rate (CRc) [Time frame: Baseline through study completion, an average of 3 years]
  • Duration of response (DOR) [Time frame: Baseline through study completion, an average of 3 years]
  • Morphological leukemia free state (MLFS) rate [Time frame: Baseline through study completion, an average of 3 years]
  • Best response rate [Time frame: Baseline through study completion, an average of 3 years]
  • Overall survival (OS) [Time frame: Baseline through study completion, an average of 3 years]
  • Event free survival (EFS) [Time frame: Baseline through study completion, an average of 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • START Midwest — Grand Rapids

Identifiers

NCT: NCT07751991 · CHM-029-01 · 2026-526409-14

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗