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

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
Charm Therapeutics
Study ID
NCT07751991
Phase
PHASE1
Status
Recruiting
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Conditions

  • AML (Acute Myeloid Leukemia)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CHM-029 — DRUG
    CHM-029 is administered orally.

Study Details

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.

Key Dates

First listed
Aug 7, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Mar 31, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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).
  • Experimental: CHM-029 Backfill
    Participants will receive CHM-029 orally at a dose level already evaluated by the Safety Review Committee (SRC).

Primary Outcome Measure

Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Baseline through Day 28 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
START MidwestGrand RapidsMichigan49546
Andrew Sochacki, MD

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START Midwest· Grand Rapids, MI

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