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

Purpose

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.

Condition

  • AML (Acute Myeloid Leukemia)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
CHM-029 Dose Escalation 		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).
  • Drug: CHM-029
    CHM-029 is administered orally.
Experimental
CHM-029 Backfill 		Participants will receive CHM-029 orally at a dose level already evaluated by the Safety Review Committee (SRC).
  • Drug: CHM-029
    CHM-029 is administered orally.

Recruiting Locations

START Midwest
Grand Rapids, Michigan 49546
Contact:
Andrew Sochacki, MD

More Details

Status
Recruiting
Sponsor
Charm Therapeutics

Study Contact

Charm Study Contact
312-682-0586
clinicaltrials@charmtx.com

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.