MRX-2843 for Advanced Refractory Cancer

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

42 Participants Needed

Trial Summary

What is the purpose of this trial?

This first-in-human open-label, dose escalation study is designed to evaluate the safety, tolerability, and PK of MRX-2843 in subjects with relapsed/refractory advanced and/or metastatic solid tumors.

Research Team

R. Donald Harvey, Pharm D

Principal Investigator

Emory University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+