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

Trial Summary

What is the purpose of this trial?

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.

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.

Research Team

William G. Blum

Principal Investigator

Emory University

Thomas B. Alexander

Principal Investigator

UNC Lineberger Comprehensive Cancer Center, Children's

Joshua Zeidner, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Melinda Pauley, MD

Principal Investigator

Emory University, Children's Healthcare of Atlanta

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+