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Advanced CancerPhase 1NCT03510104

Pharmacokinetic and Safety Study of MRX-2843 in Adults With Relapsed/Refractory Advanced and/or Metastatic Solid Tumors

A Phase 1 study testing MRX-2843 in people with Advanced Cancer and Metastatic Cancer, run by Meryx, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer, Metastatic Cancer, Neoplasms
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
42 participants
Where
2 sitesUnited States
Study dates
22 May 2018to 31 Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female at least 18 years of age.
  • Histologically or cytologically confirmed, measurable (defined as those that could be accurately measured in a least 1 dimension with a longest diameter ≥20 mm using conventional techniques or ≥10 mm with spiral computed tomography scan) or evaluable solid malignancy (with the exception of primary central nervous system [CNS] tumors) per RECIST 1.1. Scans performed within 1 month of starting study drug will be accepted.
  • Received at least one systemic therapy for advanced disease, with no further approved treatment options that provide proven clinical benefit.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  • Females of childbearing potential who are sexually active with a nonsterilized male partner agree to use 2 methods of effective contraception from screening, and agree to continue using such precautions for 90 days after the final dose of study drug; cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control.
  • Nonsterilized males who are sexually active with a female of childbearing potential must agree to use an acceptable method of effective contraception from Day 1 and for 90 days after the final dose of study drug.
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  • Female subjects of childbearing potential must be nonpregnant, nonlactating, and have a negative pregnancy test result at Screening and Day 1 of Cycles 1-6.
  • Able to provide written, informed consent before initiation of any study related procedures, and is able, in the opinion of the Investigator, to comply with all the requirements of the study.
  • Able to swallow oral medication.
  • Subject has the following laboratory values at Screening:
  • Absolute neutrophil count ≥1500/mm3
  • Platelet count ≥100,000/mm3
  • Hemoglobin ≥9.0 g/dL (must be >2 weeks post-red blood cell transfusion)
  • Bilirubin ≤1.5x the upper limit of normal (ULN). For subjects with documented Gilbert's disease, bilirubin ≤3.0 mg/dL. For subjects with documented liver metastases, bilirubin ≤ 2.5x ULN.
  • Serum creatinine ≤1.5x the ULN or creatinine clearance (CrCl) ≥50 mL/min.
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3x the ULN (≤5x the ULN for subjects with liver metastases)

Who cannot join

  • Subject has an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically significant and would preclude study participation.
  • Subject has QT interval corrected (QTc) >480 ms (both males and females) at Screening (repeat values may be obtained during the period between Screening and admission to the study site).
  • Subject 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 subject at risk for such interference (for example, short bowel syndrome or inflammatory bowel disease).
  • Subject has a history of Type 1 Diabetes (T1D) or is considered at high risk for T1D, where high risk is defined as
  • Subject has 1 first-degree relative (FDR; defined as parents, offspring or siblings) with T1D AND A1C value > 6.5% or
  • Subject has 2+FDR with T1D
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  • Subject has uncontrolled hypertension, defined as a blood pressure reading >160/100 mmHg, despite maximum antihypertensive therapy.
  • Subject has received:
  • Radionuclide treatment within 6 weeks of the first dose of study drug in this study
  • Local palliative radiation therapy (XRT) (small port) ≤2 weeks before first dose of study drug
  • Treatment with therapeutic doses of metaiodobenzylguanidine (MIBG) ≤6 weeks before first dose of study drug
  • Prior total body irradiation, total craniospinal XRT, or ≥50% radiation of pelvis within 6 months of receiving first dose of study drug
  • Treatment with a monoclonal antibody within 28 days or 5 half-lives, whichever is shorter, from treatment with first dose of study drug
  • Therapy with a growth factor within 7 days of starting study drug
  • Chemotherapy within 3 weeks of starting study drug (6 weeks if prior nitrosourea)
  • Subjects receiving systemic (oral or parenteral) corticosteroid therapy within 7 days of first dose of study drug or a requirement for chronic systemic immunosuppressive therapy for any reason. Topical or inhaled steroids are allowed.
  • Subject has not fully recovered to baseline or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) ≤ Grade 1 from toxicity due to all prior therapies, except alopecia and other non-clinically significant AEs.
  • Subject has any history of human immunodeficiency virus (HIV) or immunodeficiency at Screening.
  • Subject has a diagnosis of chronic active hepatitis B or C.
  • Subject has uncontrolled intercurrent illness including, but not limited to ongoing or active bacterial, fungal, or viral infection requiring intravenous therapy (not prophylaxis) at the time of study enrollment, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Subject has a history of a major adverse cardiac event, including cerebrovascular accident or myocardial infarction within the prior 6 months, or uncontrolled congestive heart failure (New York Heart Association class 3 or 4) at Screening.
  • Subject has active, suspected, or previously documented autoimmune disease, defined as requiring systemic treatment.
  • Subject has known or suspected history of retinitis pigmentosa or known or suspected familial history of retinitis pigmentosa.
  • Subject has prothrombin time/International Normalized Ratio or partial thromboplastin time test results at screening ≥1.5 x ULN.
  • Subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin-related agents, thrombin or FXa inhibitors, or antiplatelet agents (eg, clopidogrel). Low-dose aspirin (≤81 mg/day), low-dose warfarin (≤1 mg/day), and prophylactic low molecular weight heparin are permitted.
  • Subject had surgery (excluding line insertions) within 1 month of the first dose of study drug or has lingering wound complications.
  • Subject is unable or unwilling to abide by the study protocol or cooperate fully with the Investigator or designee.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27514

Other trials in United States

About this study

Official title: A Phase I Dose Escalation Study of the Safety, Pharmacokinetics and Pharmacodynamics of MRX-2843 in Adult Subjects With Relapsed/Refractory Advanced and/or Metastatic Solid Tumors

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.

Being tested
MRX-2843
Keywords
MerTK
Medical subject headings
Neoplasm Metastasis, Neoplasms, Neoplastic Processes, Pathologic Processes

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 groups in NCT03510104
Study groupRoleWhat they receive
MRX-2843ExperimentalMRX-2843: Dose Escalation Successive dose escalation cohorts to determine MTD
Receives: Drug: MRX-2843

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of subjects with Dose Limiting Toxicities (DLTs)

    Measured: Baseline to the end of Cycle 1 (up to 28 days)

  2. 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 12 months)

Secondary outcomes (10)

  1. Determine Maximum Tolerated Dose (MTD) in mg of MRX-2843

    Measured: Baseline to end of Cycle 1 (up to 28 days)

  2. AUC0-t: area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (t)

    Measured: Day 1 and Day 16 of Cycle 1

  3. AUC0-inf: area under the concentration-time curve from time 0 to infinity

    Measured: Day 1 and Day 16 of Cycle 1

  4. AUC0-τ: area under the concentration-time curve from time 0 to tau, where tau is the dosing interval

    Measured: Day 1 and Day 16 of Cycle 1

  5. Cmax: maximum observed plasma concentration

    Measured: Day 1 and Day 16 of Cycle 1

  6. Tmax: time to reach maximum observed plasma concentration

    Measured: Day 1 and Day 16 of Cycle 1

  7. λz: terminal phase elimination rate constant

    Measured: Day 1 and Day 16 of Cycle 1

  8. t1/2: apparent terminal elimination half-life

    Measured: Day 1 and Day 16 of Cycle 1

  9. CL/F: apparent total body clearance

    Measured: Day 1 and Day 16 of Cycle 1

  10. Vz/F: apparent volume of distribution of the terminal phase

    Measured: Day 1 and Day 16 of Cycle 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2018
  2. Study start22 May 2018
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03510104
Sponsor's protocol ID
2843-1001
Status last verified
Jan 2026
First submitted
16 Apr 2018
Last updated
8 Jan 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MRX-2843 in people with Advanced Cancer and Metastatic Cancer, run by Meryx, Inc. at 2 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 16 inclusion and 27 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: finished, 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 2 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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?

On the ClinicalTrials.gov record for NCT03510104.

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.

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