Recruiting
Phase 1

CHM-029

Sponsor:

Charm Therapeutics

Code:

NCT07751991

Conditions

AML (Acute Myeloid Leukemia)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CHM-029

Study Details

Brief 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.

Conditions

AML (Acute Myeloid Leukemia)

Study ID

NCT07751991

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

CHM-029

CHM-029 is administered orally.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Charm Study Contact

312-682-0586clinicaltrials@charmtx.com

Locations

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

More Information

Sponsor

Charm Therapeutics

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • CHM-029
  • AML
  • Menin
  • leukemia
  • NPM1
  • KMT2A
  • NUP98
  • Charm

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Charm Therapeutics on 2026-08-07.