MRX-2843 for Leukemia

Recruiting at 2 trial locations

Overseen By Meryx

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Meryx, Inc.

Must not be taking: Anticoagulants, Antiplatelets, Kinase inhibitors

Disqualifiers: CNS leukemia, Active infection, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days per cycle

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called MRX-2843, a potential drug for individuals with certain types of leukemia, specifically acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or mixed phenotype acute leukemia (MPAL), who have not responded to standard treatments. Researchers aim to determine the safest and most effective dose of MRX-2843 by administering it in varying amounts to observe how the body processes it. The trial is suitable for those whose leukemia has returned or who have not responded to previous treatments and can take oral medication. Participants should have a manageable white blood cell count or be willing to take medication to lower it if necessary. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, certain medications like systemic antineoplastic therapy, calcineurin inhibitors, and some anticoagulants are not allowed close to the start of the study. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that MRX-2843 is likely to be safe for humans?

Research has shown that MRX-2843 might be a promising treatment for certain types of leukemia. In early lab studies, this drug proved effective against leukemia cells, even those resistant to other treatments. This suggests MRX-2843 could be a potential treatment option.

Currently, MRX-2843 undergoes testing in early trials (Phase 1) to assess its safety. This phase is crucial for determining how well patients tolerate the drug and identifying any possible side effects. Although detailed safety information isn't available yet, these early trials typically use small doses to observe the body's reactions.

Since MRX-2843 remains in the early testing stages, participants should know that the complete safety profile is still being developed. Researchers will closely monitor participants for any side effects during the study. As the trials progress, more detailed safety information will be collected. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for leukemia, which often involve chemotherapy and targeted therapies like tyrosine kinase inhibitors, MRX-2843 offers a fresh approach. This investigational drug works by targeting the Mer and FLT3 receptors, which are involved in the growth and survival of cancer cells, offering a new mechanism of action. Researchers are excited about MRX-2843 because it has the potential to be more precise in attacking leukemia cells while sparing healthy cells, which could lead to fewer side effects. Additionally, its oral capsule form, taken daily over 28-day cycles, could offer a more convenient and less invasive treatment option compared to traditional infusions.

What evidence suggests that MRX-2843 might be an effective treatment for leukemia?

Research has shown that MRX-2843, a new drug under investigation in this trial, may help treat certain types of leukemia. It blocks two proteins, MERTK and FLT3, which can help overcome resistance to treatments often seen in acute myeloid leukemia (AML). In early studies, MRX-2843 significantly increased survival times in models of drug-resistant leukemia. It was also effective in about one-third of the leukemia samples tested, showing promise for difficult-to-treat cases. These early results suggest that MRX-2843 could be a valuable option for patients whose leukemia has returned or is not responding to other treatments. Participants in this trial will receive MRX-2843 at different dose escalation levels to determine the optimal dosing. ^{2 3 4 6 7}

Who Is on the Research Team?

Joshua Zeidner, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

William G. Blum

Principal Investigator

Emory University

Thomas B. Alexander

Principal Investigator

UNC Lineberger Comprehensive Cancer Center, Children's

Melinda Pauley, MD

Principal Investigator

Emory University, Children's Healthcare of Atlanta

Are You a Good Fit for This Trial?

This trial is for adolescents and adults at least 12 years old with relapsed/refractory acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or mixed phenotype acute leukemia (MPAL). Participants must weigh over 40 Kg, have specific blood test results within certain limits, be able to swallow pills, and not be pregnant. They should also agree to use double barrier contraception methods.

Inclusion Criteria

My kidney function, measured by creatinine clearance, is good.

I can care for myself but may not be able to do active work.

I have FLT3ITD+ and was treated with a FLT3 inhibitor before.

Exclusion Criteria

I haven't taken any experimental drugs or kinase inhibitors in the last 28 days or longer.

I have an ongoing infection that isn't under control.

I haven't had systemic treatment for other cancers in the last 2 years, except for certain skin or cervical conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive continuous oral MRX-2843 in 28 day cycles at predefined dose cohorts

28 days per cycle

Dose Expansion

A dose expansion arm to further evaluate patients at the RP2D

28 days per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MRX-2843

Trial Overview The study tests MRX-2843, an oral medication given in continuous cycles of 28 days to see its safety and how the body processes it. It's a Phase I trial where doses increase gradually among groups of patients until they find the highest dose that doesn't cause unacceptable side effects.

How Is the Trial Designed?

Group I: Expansion Arm at RP2D Experimental Treatment 1 Intervention

MRX-2843 capsules, QD - 28 day cycles

Group II: Dose Escalation - Level 5 Experimental Treatment 1 Intervention

MRX-2843 capsules, QD - 28 day cycles

Group III: Dose Escalation - Level 4 Experimental Treatment 1 Intervention

MRX-2843 capsules, QD - 28 day cycles

Group IV: Dose Escalation - Level 3 Experimental Treatment 1 Intervention

MRX-2843 capsules, QD - 28 day cycles

Group V: Dose Escalation - Level 2 Experimental Treatment 1 Intervention

MRX-2843 capsules, QD - 28 day cycles

Group VI: Dose Escalation - Level 1 Experimental Treatment 1 Intervention

MRX-2843 capsules, QD - 28 day cycles

Who Is Running the Clinical Trial?

Meryx, Inc.

Lead Sponsor

Trials

2

Recruited

90+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4855528/

The MERTK/FLT3 inhibitor MRX-2843 overcomes ... The MERTK/FLT3 inhibitor MRX-2843 overcomes resistance-conferring FLT3 mutations in acute myeloid leukemia.

2. unclineberger.org unclineberger.org/news-archives/mrx-2845/

New compound is effective against drug-resistant leukemia ... A novel compound has shown promise in preclinical studies as a treatment for acute myeloid leukemia, more than doubling median days of survival even in a drug- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5354980/

UNC2025, a MERTK small molecule inhibitor, is ... UNC2025 was effective in one-third of freshly isolated leukemia patient samples and our data from a small sample suggest that T-ALL and minimally ...

4. aacrjournals.org aacrjournals.org/cancerres/article/82/12_Supplement/3339/701416/Abstract-3339-MRX-2843-a-dual-MERTK-and-FLT3

Abstract 3339: MRX-2843, a dual MERTK and FLT3 inhibitor ... While overall outcomes have improved for patients with acute leukemia, high-risk subsets including acute myeloid leukemia (AML) and relapsed ...

5. pubs.acs.org pubs.acs.org/doi/10.1021/jm500749d

UNC2025, a Potent and Orally Bioavailable MER/FLT3 Dual ... A new potent and highly orally bioavailable Mer inhibitor, 11, capable of inhibiting Mer phosphorylation in vivo, following oral dosing.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04872478

Pharmacokinetic and Safety Study of MRX-2843 in ... 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, ...

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04946890?recrs=abdefghim

A Study of MRX2843 in Subjects With Relapsed/Refractory Acute ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.