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

Status
Closed
Cancer Type
Solid Tumor
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03510104
Protocol IDs
2843-1001 (primary)
NCI-2018-01102
Study Sponsor
Meryx, Inc.

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.

Eligibility

  1. Male or female at least 18 years of age.
  2. 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.
  3. Received at least one systemic therapy for advanced disease, with no further approved treatment options that provide proven clinical benefit.
  4. Eastern Cooperative Oncology Group (ECOG) performance status =2.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. Able to swallow oral medication.
  10. Subject has the following laboratory values at Screening:
  11. Absolute neutrophil count =1500/mm3
  12. Platelet count =100,000/mm3
  13. Hemoglobin =9.0 g/dL (must be >2 weeks post-red blood cell transfusion)
  14. 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.
  15. Serum creatinine =1.5x the ULN or creatinine clearance (CrCl) =50 mL/min.
  16. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3x the ULN (=5x the ULN for subjects with liver metastases)

Treatment Sites in Georgia

Emory University Hospital - Atlanta


1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

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