Acute Myeloid LeukemiaPhase 1NCT04872478
Pharmacokinetic and Safety Study of MRX-2843 in Adolescents and Adults With Relapsed/Refractory AML, ALL, or MPAL
A Phase 1 study testing MRX-2843 in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Meryx, Inc. at 3 sites in United States.
Trial summary
This is a Phase I, open-label, non-randomized, dose escalation study in adolescents and adults with relapsed/refractory acute myeloid leukemia, acute lymphoblastic leukemia, or mixed phenotype acute leukemia. Patients will receive continuous oral MRX-2843 in 28 day cycles at predefined dose cohorts. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia
- What is being tested?
- MRX-2843
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Apr 2022to Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient is a male or female at least 12 years of age.
- Patient must weigh at least 40 Kg.
- Patient has histologically or cytologically confirmed diagnosis of AML as defined by the World Health Organization (WHO) criteria (2017), ALL, or MPAL and is in second or later relapse or is refractory to at least one induction regimen.
- The effects of MRX-2843 on developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to remain abstinent, or agree to practice double barrier forms of birth control in which 2 of the following precautions are used during the study and for 4 months after last dose of study drug(s): vasectomy, tubal ligation (or other transcervical sterilization procedures), vaginal diaphragm, intrauterine device, birth control pills, birth control implant, or condom or sponge with spermicide.
- Female patients of childbearing potential must be nonpregnant, nonlactating, and have a negative pregnancy test result at Screening and a negative pregnancy test on Day 1 of Cycles 1-4.
- Patient is able to provide written, informed consent or assent for patients < 18 years of age is provided along with parent/guardian consent before initiation of any study related procedures, and patient is able, in the opinion of the investigator, to comply with all the requirements of the study.
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- Patient is able to swallow oral medication.
- Patient has white blood cell (WBC) lower than 25,000/mm3 at Screening prior to initiation of MRX-2843. Patients who are otherwise medically eligible for enrollment but have WBC above 25,000/mm3 are allowed concurrent treatment with hydroxyurea to stabilize the WBC. In these situations, hydroxyurea will be discontinued once WBC is below 10,000/mm3 and at least 1 day prior to start of study treatment. Treatment with hydroxyurea will be allowed during Cycle 1 if deemed needed by the Investigator.
- The Patient has laboratory values at Screening:
- Bilirubin ≤ 1.5 the upper limit of normal (ULN). For patients with documented Gilbert's disease, bilirubin ≤ 3.0 mg/dL
- Creatinine clearance (CrCl) ≥ 60 mL/min. For creatinine clearance estimation, the Cockcroft and Gault equation should be used:
- Male: CrCl (mL/min) = (140 - age) × wt (kg) / (serum creatinine × 72) (For females: Multiply above result by 0.85)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN
- Patient has Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Lansky/Karnofsky ≥ 50.
- For the FLT3ITD expansion cohort at RP2D, the FLT3ITD+ patients should have previously been treated with at least one FLT3 inhibitor prior to enrollment.
Who cannot join
- To be eligible for this study, each of the following criteria must be satisfied with a "NO" answer:
- All Subjects:
- Patient has diagnosis of acute promyelocytic leukemia (or AML M3).
- Patients with known active CNS leukemia.
- Patient has any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study drug, or any other condition that may place the patient at risk.
- Patient has a history of other malignancies that have required systemic treatment within the last 2 years or are deemed by the investigator to have a potential to interfere with the safety and efficacy assessment of MRX2843. Patients with treated nonmelanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed.
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- Patient has received radionuclide treatment within 6 weeks of the first dose of study treatment.
- Patient has received systemic antineoplastic therapy within 14 days of study treatment or 6 weeks for nitrosoureas or mitomycin C. (However, hydroxyurea can be given for the purposes of cytoreduction up to 1 day prior to enrollment, with the exceptions noted above in the inclusion criteria).
- Patient has not fully recovered from acute toxic effects due to all prior therapies, except alopecia and other non-clinically significant AEs prior to enrollment.
- Patient has active clinically significant GvHD.
- Patient has received calcineurin inhibitors within four weeks of study treatment.
- Patient is known to have human immunodeficiency virus infection (HIV).
- Patient has used a small molecular kinase inhibitor or any investigational drug or product within 28 days or 5 half lives, whichever is longer, before study drug dosing.
- Patient has a diagnosis of active hepatitis B or C.
- Patient has an active uncontrolled infection.
- Patient has a history of Type 1 Diabetes (T1D) or is considered at high risk for T1D, where high risk is defined as
- Patient has 1 first-degree relative (FDR; defined as parents, offspring or siblings) with T1D AND A1C value > 6.5% or
- Patient has 2+FDR with T1D
- Patient has known or suspected history of retinitis pigmentosa or known or suspected familial history of retinitis pigmentosa.
- Patient requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or coumadin-related agents, thrombin or FXa inhibitors, and antiplatelet agents (e.g., clopidogrel). Low dose aspirin (≤ 81 mg/day), low-dose warfarin (≤1 mg/day), and prophylactic Low Molecular Weight Heparin (LMWH) are permitted.
- Patient has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patient with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within 3 months prior to study entry results in a left ventricular ejection fraction that is ≥ 45%.
- Patient has QTcF > 480 ms.
- Patient has had major surgery within 4 weeks of the first dose of study drug.
- The patient is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Emory University - WINSHIP Cancer Center
Atlanta, Georgia, 30322
William Blum, MD
- Recruiting
Emory University, Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Melinda Pauly, MD
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Dr. Neerav Shukla
Neerav Shukla
About this study
Official title: An Open Label Evaluation Phase 1 Trial of the Safety and Pharmacokinetics of MRX-2843 in Adolescents and Adults With Relapsed/Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Mixed Phenotype Acute Leukemia
This is a Phase I, open-label, non-randomized, dose escalation study in adolescents and adults with relapsed/refractory acute myeloid leukemia, acute lymphoblastic leukemia, or mixed phenotype acute leukemia. Patients will receive continuous oral MRX-2843 in 28 day cycles at predefined dose cohorts.
Read the detailed description
This is a Phase I, open-label, non-randomized, dose escalation study in up to 50 adolescent or adult patients with relapsed/refractory acute myeloid leukemia, acute lymphoblastic leukemia, or mixed phenotype acute leukemia. Patients will receive a single dose of MRX-2843 followed by continuous oral MRX-2843 in 28 day cycles at predefined dose cohorts.
A dose expansion arm of approximately 12 patients (with 6 patients being FLT3 ITD+ and 6 patients being Mer+/FLT3 WT) will be accrued to further evaluate patients at the RP2D.
- Being tested
- MRX-2843
- Keywords
- MerTK Inhibitor
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Biphenotypic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRX-2843Drug
MRX-2843 capsules
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation - Level 1 | Experimental | MRX-2843 capsules, QD - 28 day cycles Receives: Drug: MRX-2843 |
| Dose Escalation - Level 2 | Experimental | MRX-2843 capsules, QD - 28 day cycles Receives: Drug: MRX-2843 |
| Dose Escalation - Level 3 | Experimental | MRX-2843 capsules, QD - 28 day cycles Receives: Drug: MRX-2843 |
| Dose Escalation - Level 4 | Experimental | MRX-2843 capsules, QD - 28 day cycles Receives: Drug: MRX-2843 |
| Dose Escalation - Level 5 | Experimental | MRX-2843 capsules, QD - 28 day cycles Receives: Drug: MRX-2843 |
| Expansion Arm at RP2D | Experimental | MRX-2843 capsules, QD - 28 day cycles Receives: Drug: MRX-2843 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with Dose Limiting Toxicities (DLTs)
Measured: Baseline to the end of Cycle 1 (up to 28 days)
Percentage of subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs) graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5
Measured: Baseline up to 14 days after last dose of study treatment (up to approximately 8 months)
Secondary outcomes (10)
Determine Maximum Tolerated Dose (MTD) in mg of MRX-2843
Measured: Baseline to end of Cycle 1 (up to 28 days)
AUC0-t: area under the concentration-time curve from time 0 to the time of the last
Measured: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
AUC0-inf: area under the concentration-time curve from time 0 to infinity
Measured: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
AUC0-τ: area under the concentration-time curve from time 0 to tau, where tau is the dosing interval
Measured: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
Cmax: maximum observed plasma concentration
Measured: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
Tmax: time to reach maximum observed plasma concentration
Measured: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
λz: terminal phase elimination rate constant
Measured: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
t1/2: apparent terminal elimination half-life
Measured: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
CL/F: apparent total body clearance
Measured: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
Vz/F: apparent volume of distribution of the terminal phase
Measured: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start1 Apr 2022
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Patients will be accrued using a 3+3 approach. Cohorts will be escalated based on review of safety data for each patient and cohort. The highest dose level administered prior to the dose in which ≥ 33% of patients experience a dose-limiting toxicity \[DLT\]) will be defined as the MTD. Based on PK, pharmacodynamic data, efficacy, safety and patient tolerability, a recommended dose for further development (RP2D) may be identified that is less than the formal MTD. A dose expansion arm of approximately 12 patients (with 6 patients being FLT3 ITD+ and 6 patients being Mer+/FLT3 WT) will be accrued to further evaluate patients at the RP2D.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meryx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melinda Pauley, MD, Principal investigator, Emory University, Children's Healthcare of AtlantaWilliam Blum, MD, Principal investigator, Emory UniversityThomas Alexander, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center, Children'sJoshua Zeidner, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872478
- Sponsor's protocol ID
- 2843-1003
- Status last verified
- Jan 2026
- First submitted
- 29 Apr 2021
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Evaluation Phase 1 Trial of the Safety and Pharmacokinetics of MRX-2843 in Adolescents and Adults With Relapsed/Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Mixed Phenotype Acute Leukemia
- ClinicalTrials.gov ID
- NCT04872478
- Acronym / sponsor ID
- 2843-1003
- Keywords
- MerTK Inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meryx, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I, open-label, non-randomized, dose escalation study in adolescents and adults with relapsed/refractory acute myeloid leukemia, acute lymphoblastic leukemia, or mixed phenotype acute leukemia. Patients will receive continuous oral MRX-2843 in 28 day cycles at predefined dose cohorts.
Detailed description
This is a Phase I, open-label, non-randomized, dose escalation study in up to 50 adolescent or adult patients with relapsed/refractory acute myeloid leukemia, acute lymphoblastic leukemia, or mixed phenotype acute leukemia. Patients will receive a single dose of MRX-2843 followed by continuous oral MRX-2843 in 28 day cycles at predefined dose cohorts.
A dose expansion arm of approximately 12 patients (with 6 patients being FLT3 ITD+ and 6 patients being Mer+/FLT3 WT) will be accrued to further evaluate patients at the RP2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Patients will be accrued using a 3+3 approach. Cohorts will be escalated based on review of safety data for each patient and cohort. The highest dose level administered prior to the dose in which ≥ 33% of patients experience a dose-limiting toxicity [DLT]) will be defined as the MTD. Based on PK, pharmacodynamic data, efficacy, safety and patient tolerability, a recommended dose for further development (RP2D) may be identified that is less than the formal MTD. A dose expansion arm of approximately 12 patients (with 6 patients being FLT3 ITD+ and 6 patients being Mer+/FLT3 WT) will be accrued to further evaluate patients at the RP2D.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation - Level 1 | Experimental | Drug: MRX-2843MRX-2843 capsules, QD - 28 day cycles |
| Dose Escalation - Level 2 | Experimental | Drug: MRX-2843MRX-2843 capsules, QD - 28 day cycles |
| Dose Escalation - Level 3 | Experimental | Drug: MRX-2843MRX-2843 capsules, QD - 28 day cycles |
| Dose Escalation - Level 4 | Experimental | Drug: MRX-2843MRX-2843 capsules, QD - 28 day cycles |
| Dose Escalation - Level 5 | Experimental | Drug: MRX-2843MRX-2843 capsules, QD - 28 day cycles |
| Expansion Arm at RP2D | Experimental | Drug: MRX-2843MRX-2843 capsules, QD - 28 day cycles |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Patient is a male or female at least 12 years of age.
- Patient must weigh at least 40 Kg.
- Patient has histologically or cytologically confirmed diagnosis of AML as defined by the World Health Organization (WHO) criteria (2017), ALL, or MPAL and is in second or later relapse or is refractory to at least one induction regimen.
- The effects of MRX-2843 on developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to remain abstinent, or agree to practice double barrier forms of birth control in which 2 of the following precautions are used during the study and for 4 months after last dose of study drug(s): vasectomy, tubal ligation (or other transcervical sterilization procedures), vaginal diaphragm, intrauterine device, birth control pills, birth control implant, or condom or sponge with spermicide.
- Female patients of childbearing potential must be nonpregnant, nonlactating, and have a negative pregnancy test result at Screening and a negative pregnancy test on Day 1 of Cycles 1-4.
Key exclusion criteria (24 listed)
- To be eligible for this study, each of the following criteria must be satisfied with a "NO" answer:
- Patient has diagnosis of acute promyelocytic leukemia (or AML M3).
- Patients with known active CNS leukemia.
- Patient has any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study drug, or any other condition that may place the patient at risk.
- Patient has a history of other malignancies that have required systemic treatment within the last 2 years or are deemed by the investigator to have a potential to interfere with the safety and efficacy assessment of MRX2843. Patients with treated nonmelanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRX-2843MRX-2843 capsules | Drug | Dose Escalation - Level 1, Dose Escalation - Level 2, Dose Escalation - Level 3, Dose Escalation - Level 4, Dose Escalation - Level 5, Expansion Arm at RP2D |
Primary outcome
Percentage of subjects with Dose Limiting Toxicities (DLTs)
Time frame: Baseline to the end of Cycle 1 (up to 28 days)
Percentage of subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs) graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5
Time frame: Baseline up to 14 days after last dose of study treatment (up to approximately 8 months)
10 secondary outcomes
Determine Maximum Tolerated Dose (MTD) in mg of MRX-2843
Time frame: Baseline to end of Cycle 1 (up to 28 days)
AUC0-t: area under the concentration-time curve from time 0 to the time of the last
Time frame: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
AUC0-inf: area under the concentration-time curve from time 0 to infinity
Time frame: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
AUC0-τ: area under the concentration-time curve from time 0 to tau, where tau is the dosing interval
Time frame: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
Cmax: maximum observed plasma concentration
Time frame: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
Tmax: time to reach maximum observed plasma concentration
Time frame: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
λz: terminal phase elimination rate constant
Time frame: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
t1/2: apparent terminal elimination half-life
Time frame: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
CL/F: apparent total body clearance
Time frame: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
Vz/F: apparent volume of distribution of the terminal phase
Time frame: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melinda Pauley, MD principal investigator
Emory University, Children's Healthcare of Atlanta
William Blum, MD principal investigator
Emory University
Thomas Alexander, MD principal investigator
UNC Lineberger Comprehensive Cancer Center, Children's
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MRX-2843 in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Meryx, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meryx (919-270-4667, safety@meryxpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with Dose Limiting Toxicities (DLTs) (time frame: Baseline to the end of Cycle 1 (up to 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.