A Study of REC-4881 in Participants with Cancers Which Have an AXIN1 or APC Mutation

Last updated: November 26, 2024
Sponsor: Recursion Pharmaceuticals Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Neuroblastoma

Colon Cancer

Treatment

REC-4881

Clinical Study ID

NCT06005974
REC-4881-221
  • Ages > 55
  • All Genders

Study Summary

This is a multi-center, open-label study to investigate the safety, efficacy and pharmacokinetics of REC-4881 (12 mg PO daily doses) for the treatment of participants with unresectable locally advanced or metastatic solid tumors with AXIN1 or APC mutation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 55 years of age or older with histologically-confirmed unresectable, locallyadvanced, or metastatic solid tumor with AXIN1 or APC mutation. If a participant hascolorectal cancer, then they must be RAS / RAF wild type to enroll into the APCmutant cohort

  2. Have experienced progressive disease, relapsed disease, or be intolerant to at leastone established standard systemic anti-cancer treatment, or in the opinion of theInvestigator have been considered ineligible for standard therapy

  3. Measurable disease at baseline per RECIST 1.1 criteria

  4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Exclusion

Exclusion Criteria:

  1. Received treatment with another mitogen-activated protein kinase (MEK) inhibitorwithin two months of first dose of REC-4881

  2. Left ventricular ejection fraction (LVEF) <50% as measured by echocardiogram (ECHO)or multigated acquisition (MUGA) scan

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: REC-4881
Phase: 2
Study Start date:
January 15, 2024
Estimated Completion Date:
January 31, 2027

Study Description

Approximately 60 individuals will be enrolled in this open-label Phase 2 study, allocated 1:1 between the 2 cohorts - AXIN1 mutation or APC mutation. The purpose of the study is to investigate the safety, efficacy, and pharmacokinetics of REC-4881 for the treatment of participants with unresectable locally advanced or metastatic solid tumors with either mutation. Participants will receive treatment with REC-4881 (12mg PO daily) for up to 2 years.

Connect with a study center

  • Yuma Regional Medical Center

    Yuma, Arizona 85364
    United States

    Site Not Available

  • Highlands Oncology

    Springdale, Arkansas 72762
    United States

    Site Not Available

  • TOI Clinical Research

    Cerritos, California 90703
    United States

    Site Not Available

  • Providence Medical Foundation (Fullerton)

    Fullerton, California 92835
    United States

    Site Not Available

  • MemorialCare

    Long Beach, California 90806
    United States

    Site Not Available

  • Cancer and Blood Research Center

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Sharp HealthCare

    San Diego, California 92123
    United States

    Site Not Available

  • Sharp Memorial Hospital

    San Diego, California 92123
    United States

    Site Not Available

  • Ridley-Tree Cancer Center

    Santa Barbara, California 93105
    United States

    Site Not Available

  • Sansum Clinic

    Santa Barbara, California 93105
    United States

    Site Not Available

  • Providence Medical Foundation (Santa Rosa)

    Santa Rosa, California 95405
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers

    Denver, Colorado 80218
    United States

    Site Not Available

  • Eastern Connecticut Hematology & Oncology Associates

    Norwich, Connecticut 06360
    United States

    Site Not Available

  • Medical Oncology Hematology Consultants

    Newark, Delaware 19713
    United States

    Site Not Available

  • Cancer Specialists of North Florida

    Fleming Island, Florida 32003
    United States

    Site Not Available

  • Holy Cross Hospital

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Cancer Specialists of North Florida

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • TOI Florida

    Lakeland, Florida 33812
    United States

    Site Not Available

  • Ocala Oncology

    Ocala, Florida 34474
    United States

    Site Not Available

  • University Cancer & Blood Center

    Athens, Georgia 30607
    United States

    Site Not Available

  • Hope and Healing Cancer Services

    Hinsdale, Illinois 60521
    United States

    Site Not Available

  • Northwest Oncology & Hematology

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Community Health Network

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Beacon Health System

    South Bend, Indiana 46601
    United States

    Site Not Available

  • Mission Cancer And Blood

    Des Moines, Iowa 50314
    United States

    Site Not Available

  • Our Lady of the Lake

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • Pontchartrain

    Covington, Louisiana 70433
    United States

    Site Not Available

  • American Oncology Partners of Maryland, PA

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • The Center for Cancer and Blood Disorders

    Germantown, Maryland 20874
    United States

    Site Not Available

  • Southcoast Centers for Cancer Care

    Fairhaven, Massachusetts 02719
    United States

    Site Not Available

  • Saint Luke's Hospital

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Mosaic Life Care

    Saint Joseph, Missouri 64507
    United States

    Site Not Available

  • Oncology Hematology Associates

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Nebraska Cancer Specialists

    Omaha, Nebraska 68130
    United States

    Site Not Available

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada 89169
    United States

    Site Not Available

  • OptumCare Cancer Care

    Las Vegas, Nevada 89102
    United States

    Active - Recruiting

  • New Jersey Cancer Care

    Belleville, New Jersey 07109
    United States

    Site Not Available

  • Englewood Health

    Englewood, New Jersey 07631
    United States

    Site Not Available

  • Summit Medical Group

    Florham Park, New Jersey 07932
    United States

    Site Not Available

  • Hunterdon Hematology Oncology

    Hillsborough, New Jersey 08844
    United States

    Site Not Available

  • HOACNY

    East Syracuse, New York 13057
    United States

    Site Not Available

  • Sanford Health - Fargo

    Fargo, North Dakota 58102
    United States

    Site Not Available

  • Aultman Medical Group

    Canton, Ohio 44710
    United States

    Site Not Available

  • TriHealth Cancer Institute

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • The Toledo Clinic

    Toledo, Ohio 43623
    United States

    Site Not Available

  • Ssm Health Care Of Oklahoma- Inc.

    Oklahoma City, Oklahoma 73102
    United States

    Site Not Available

  • Oklahoma Cancer Specialists and Research Institute

    Tulsa, Oklahoma 74146
    United States

    Site Not Available

  • Oregon Oncology Specialists

    Salem, Oregon 97301
    United States

    Site Not Available

  • PCSRI - Gettysburg

    Gettysburg, Pennsylvania 17325
    United States

    Site Not Available

  • Cancer Care Associates of York

    York, Pennsylvania 17403
    United States

    Site Not Available

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

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Sanford Health

    Sioux Falls, South Dakota 57104
    United States

    Active - Recruiting

  • Mary Crowley Cancer Research

    Dallas, Texas 75230
    United States

    Site Not Available

  • Mary Crowley Cancer Research Centers

    Dallas, Texas 75231
    United States

    Site Not Available

  • Oncology Consultants

    Houston, Texas 77030
    United States

    Site Not Available

  • Lumi Research

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Utah Cancer Specialists

    Salt Lake City, Utah 84106
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Hematology Oncology Associates of Fredericksburg

    Fredericksburg, Virginia 22408
    United States

    Site Not Available

  • PeaceHealth

    Bellingham, Washington 98225
    United States

    Site Not Available

  • Vista Oncology

    Olympia, Washington 98506
    United States

    Site Not Available

  • Cancer Care Northwest

    Spokane, Washington 99202
    United States

    Site Not Available

  • Northwest Medical Specialties

    Tacoma, Washington 98405
    United States

    Site Not Available

  • ThedaCare

    Appleton, Wisconsin 54911
    United States

    Site Not Available

  • Gundersen Health System

    La Crosse, Wisconsin 54061
    United States

    Site Not Available

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