MRX-2843 for Advanced Refractory Cancer

Not currently recruiting at 1 trial location

Overseen By Meryx

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Meryx, Inc.

Must not be taking: Corticosteroids, Anticoagulants

Disqualifiers: Type 1 diabetes, Hypertension, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effects of a new treatment, MRX-2843, for individuals with advanced solid tumors unresponsive to other treatments. The goal is to determine how well the body tolerates various doses of MRX-2843. Suitable candidates for this trial have solid tumors that have recurred or spread, have tried other treatments without success, and lack other approved treatment options. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, certain treatments like chemotherapy, corticosteroids, and some anticoagulants must be stopped before starting the study drug. 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 shows that MRX-2843 is being tested for safety in people with recurrent or hard-to-treat cancers. Earlier patients generally tolerated MRX-2843 well. Participants in these studies experienced some side effects, but they were mostly manageable. This treatment targets specific proteins linked to cancer growth, potentially enhancing its effectiveness in the body. As this is an early-phase study, researchers are still determining the best dose to minimize side effects. Safety data from studies in people with acute myeloid leukemia showed similar results, with no unexpected safety concerns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for advanced refractory cancer, which often include chemotherapy and targeted therapies, MRX-2843 offers a fresh approach by specifically targeting a unique mechanism. MRX-2843 is designed to inhibit the Mer and Axl receptor tyrosine kinases, which play a crucial role in cancer cell survival and proliferation. This targeted action could potentially lead to more effective outcomes with fewer side effects compared to traditional therapies. Researchers are excited because MRX-2843 not only tackles the cancer cells directly but also might overcome resistance seen in current treatment options.

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

Research has shown that MRX-2843, a drug targeting specific proteins, holds promise in fighting cancer. In early animal studies, MRX-2843 significantly reduced tumor size and improved survival rates in mice compared to untreated ones. It also increased cancer cells' responsiveness to chemotherapy. Although this trial focuses on MRX-2843 alone, previous studies have demonstrated that combining it with another drug, venetoclax, enhances its effectiveness. These findings suggest that MRX-2843 could help treat advanced cancers by directly attacking tumor cells and enhancing the effects of other treatments. ^{1 3 4 6 7}

Who Is on the Research Team?

R. Donald Harvey, Pharm D

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

Adults with advanced solid tumors that have relapsed or spread, who've tried at least one treatment without success. They must be over 18, able to take oral meds, and not pregnant or breastfeeding. Participants need normal organ function tests and agree to use effective contraception during the trial.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

I am a man who can father children and will use birth control.

I am not pregnant, not breastfeeding, and my pregnancy test was negative.

Exclusion Criteria

Subject has QT interval corrected (QTc) >480 ms at Screening

I had surgery less than a month ago or have ongoing wound issues.

Subject has specific prothrombin time/International Normalized Ratio or partial thromboplastin time test results at screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Successive dose escalation cohorts to determine the maximum tolerated dose (MTD) of MRX-2843

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 is testing MRX-2843's safety and how it moves through the body (pharmacokinetics) in people with stubborn cancers that haven't responded well to other treatments. It's an early-stage trial where everyone gets MRX-2843.

How Is the Trial Designed?

Group I: MRX-2843 Experimental Treatment 1 Intervention

MRX-2843: Dose Escalation Successive dose escalation cohorts to determine MTD

Who Is Running the Clinical Trial?

Meryx, Inc.

Lead Sponsor

Trials

2

Recruited

90+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03510104

Pharmacokinetic and Safety Study of MRX-2843 in Adults ... This first-in-human open-label, dose escalation study is designed to evaluate the safety, tolerability, and PK of MRX-2843 in subjects with ...

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

UNC2025, a MERTK small molecule inhibitor, is ... UNC2025 inhibited MERTK in bone marrow leukemia cells and had significant therapeutic effects in xenograft models, with dose-dependent decreases in tumor burden ...

3. researchgate.net researchgate.net/publication/264433992_UNC2025_a_potent_and_orally_bioavailable_MERFLT3_dual_inhibitor

UNC2025, a potent and orally bioavailable MER/FLT3 dual ... MRX-2843 and related MERTK TKIs mediate direct tumor cell killing in preclinical models and promote sensitivity to chemotherapy in vitro and in murine models of ...

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 ... Combined treatment with MRX-2843 and venetoclax provided enhanced therapeutic efficacy compared to MRX-2843 or venetoclax alone. The interaction ...

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

The MERTK/FLT3 inhibitor MRX-2843 overcomes ... Treatment with MRX-2843 significantly prolonged survival relative to that of vehicle-treated mice, with median survival increasing from 37 days ...

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. georgiacancerinfo.org georgiacancerinfo.org/clinical-trials/detail/5251

Pharmacokinetic and Safety Study of MRX-2843 in ... Summary. This is a Phase I, open-label, non-randomized, dose escalation study in adolescents and adults with relapsed/refractory acute myeloid leukemia, ...