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

NCT03510104 | Completed Phase 1 FDA Drug

• 1 other identifier: 2843-1001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Advanced Cancer; Metastatic Cancer; Neoplasms; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes

Keywords

MerTK

Outcome Measures

Primary Outcomes (2)

• Percentage of subjects with Dose Limiting Toxicities (DLTs)

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

• 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

  Baseline up to 14 days after last dose of study treatment (up to approximately 12 months)

Secondary Outcomes (10)

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

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

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

  Day 1 and Day 16 of Cycle 1

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

  Day 1 and Day 16 of Cycle 1

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

  Day 1 and Day 16 of Cycle 1

• Cmax: maximum observed plasma concentration

  Day 1 and Day 16 of Cycle 1

Study Arms (1)

MRX-2843

EXPERIMENTAL

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

Drug: MRX-2843

Interventions

MRX-2843 DRUG

MRX-2843 capsules

MRX-2843

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Meryx, Inc.: lead

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

Location

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms; Neoplastic Processes; Pathologic Processes

Interventions

MRX-2843

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

• Donald Harvey

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: April 27, 2018
• Study Start: May 22, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)