A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
ConditionAML (Acute Myeloid Leukemia)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCharm Therapeutics
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
CHM-029
Drugoral
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: CHM-029 Dose EscalationExperimental treatment 1 intervention
Group B: CHM-029 BackfillExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with dose limiting toxicities (DLTs)
A DLT is defined as any Adverse Event (AE) which meets DLT criteria, not clearly due to the underlying disease or extraneous causes, that occurs within the DLT observation period.
Time frame
Baseline through Day 282
Number of participants with adverse events (AEs)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame
Baseline through study completion, an average of 3 years3
Number of participants with adverse events (AEs) by severity
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0
Time frame
Baseline through study completion, an average of 3 years4
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant laboratory values.
Time frame
Baseline through study completion, an average of 3 yearsSecondary outcomes
1
Pharmacokinetics (PK) profile of CHM-029: Plasma concentrations
Maximum plasma concentrations of CHM-029 will be reported.
Time frame
Baseline through study completion, an average of 3 years2
Pharmacokinetic (PK) profile of CHM-029: Area under the curve
Pharmacokinetics will be calculated including the area under the plasma concentration versus time curve (AUC)
Time frame
Baseline through study completion, an average of 3 years3
Pharmacokinetic (PK) profile of CHM-029: Time of maximum concentration (Tmax) and half-life (T1/2)
Pharmacokinetic parameters will be calculated using standard non-compartmental techniques
Time frame
Baseline through study completion, an average of 3 years4
Complete remission and complete remission with partial hematological recovery (CR/CRh) rate
The CR/CRh rate is defined as the number of participants who achieved either CR or CRh at any of the post baseline visits divided by the number of participants in the analysis population.
Time frame
Baseline to study completion, an average of 3 yearsSponsors and contacts
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Source ClinicalTrials.gov