A Study of the Drug REC-4881 For Treating People with Advanced Cancers with an APC or AXIN1 Mutation

About the Study

This study is looking at how well the research drug REC-4881 works and how safe it is for the treatment of people with advanced or metastatic cancers with an APC or AXIN1 mutation. REC-4881 is a type of targeted therapy drug known as a MEK1/2 inhibitor. 

What the Study Involves

Participants will be assigned to one of two groups based on the results of tumor testing. All participants will receive the drug REC-4881.

• Group 1: tumors with AXIN1 mutations
• Group 2: tumors with APC mutations (this may include people with an inherited APC mutation and/or a type of inherited syndrome known as Familial Adenomatous Polyposis (FAP or AFAP) 

Participants will take REC-4881 once daily by mouth for up to 2 years. Follow up will include office visits, lab tests and imaging to track response to the treatment. 

Study Locations

Note: For all study locations, the contact is: trials@tempus.com.

Arizona

• Yuma, AZ
  Yuma Regional Medical Center

Arkansas 

• Springdale, AR
  Highlands Oncology

California

• Cerritos, CA
  TOI Clinical Research
• Fullerton, CA
  Providence Medical Foundation (Fullerton)
• Long Beach, CA
  MemorialCare
• Los Alamitos, CA
  Cancer and Blood Research Center
• San Diego, CA
  Sharp HealthCare
• Santa Barbara, CA
  Ridley-Tree Cancer Center
• Santa Rosa, CA
  Providence Medical Foundation (Santa Rosa)

Connecticut

• Norwich, CT
  Eastern Connecticut Hematology & Oncology Associates

Florida

• Fort Lauderdale, FL
  Holy Cross Hospital
• Jacksonville, FL
  Cancer Specialists of North Florida
• Lakeland, FL
  TOI Florida

Georgia

• Athens, GA
  University Cancer & Blood Center

Illinois

• Hinsdale, IL
  Hope and Healing Cancer Services
• Rolling Meadows, IL
  Northwest Oncology & Hematology

Indiana

• Fort Wayne, IN
   Fort Wayne Medical Oncology and Hematology
• Indianapolis, IN
  Community Health Network

Louisiana

• Baton Rouge, LA
  Our Lady of the Lake

Maryland

• Germantown, MD
  The Center for Cancer and Blood Disorders

Massachusetts

• Fairhaven, MA
  Southcoast Centers for Cancer Care

Missouri 

• Saint Joseph, MO
  Mosaic Life Care

Nebraska 

• Omaha, NE
  Nebraska Cancer Specialists

Nevada

• Las Vegas, NV
  OptumCare Cancer Care
• Las Vegas, NV
  Comprehensive Cancer Centers of Nevada

New Jersey

• Belleville, NJ
  New Jersey Cancer Care
• Englewood, NJ
  Englewood Health
• Florham Park, NJ
  Summit Medical Group

New York

• East Syracuse, NY
  HOACNY

North Dakota

• Fargo, ND
  Sanford Health - Fargo

Ohio

• Canton, OH
  Aultman Medical Group
• Cincinnati, OH
  TriHealth Cancer Institute
• Toledo, OH
  The Toledo Clinic

Oklahoma

• Oklahoma City, OK
  Ssm Health Care Of Oklahoma- Inc.
• Tulsa, OK
  Oklahoma Cancer Specialists and Research Institute

Oregon

• Salem, OR
  Oregon Oncology Specialists

Pennsylvania

• Gettysburg, PA
  PCSRI - Gettysburg
• York, PA
  Cancer Care Associates of York

South Carolina

• Greenville, SC
  Bon Secours (Greenville) - St. Francis Cancer Center

South Dakota

• Sioux Falls, SD
  Sanford Health
• Sioux Falls, SD
  Avera Cancer Institute

Texas

• Houston, TX
  Oncology Consultants
• Sugar Land, TX
  Lumi Research

Utah

• Salt Lake City, UT
  Utah Cancer Specialists

Virginia

• Fredericksburg, VA
  Hematology Oncology Associates of Fredericksburg

Washington

• Bellingham, WA
  PeaceHealth
• Olympia, WA
  Vista Oncology
• Spokane, WA
  Cancer Care Northwest
• Tacoma, WA
  Northwest Medical Specialties

Wisconsin

• Appleton, WI
  ThedaCare
• La Crosse, WI
  Gundersen Health System

• People with the following may be eligible:
• 55 years of age or older with locally advanced, or metastatic solid tumor with AXIN1 or APC mutation.
• People with an APC mutation with colorectal cancer must not have a RAS / RAF mutation.
• Have experienced progressive disease, relapsed disease, or be intolerant to at least one established standard systemic treatment, or are ineligible for standard therapy.
• Have measurable disease.

The following people are not eligible:

• People who received treatment with MEK inhibitor drug must wait at least 2 months before the first dose of REC-4881.
• People with heart disease measured by echocardiogram (ECHO) or MUGA scan.