Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-Line Treatment of Metastatic Colorectal Cancer in Adult Participants With a KRAS or NRAS Mutation

Last updated: April 25, 2025
Sponsor: Cardiff Oncology
Overall Status: Active - Not Recruiting

Phase

2

Condition

Colorectal Cancer

Metastatic Cancer

Treatment

FOLFIRI

Bevacizumab

Onvansertib

Clinical Study ID

NCT06106308
CRDF-004
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to assess 2 different doses of onvansertib to select the lowest dose that is maximally effective, and to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of onvansertib in combination with FOLFIRI + bevacizumab or FOLFOX + bevacizumab in patients with KRAS or NRAS-mutated metastatic colorectal cancer (CRC) in the first-line setting.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed metastatic colorectal cancer.

  • Documented KRAS or NRAS mutation.

  • No previous systemic therapy in the metastatic setting.

  • Participants must be willing to submit archival tissue or undergo fresh biopsy.

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  • Women of childbearing potential must use contraception or take measures to avoidpregnancy.

  • Imaging computed tomography (CT) or magnetic resonance imaging (MRI) ofchest/abdomen/pelvis and other scans as necessary to document all sites of diseaseperformed within 28 days prior to the first dose of onvansertib.

  • Must have acceptable organ function

Exclusion

Exclusion Criteria:

  • Concomitant KRAS or NRAS and BRAF-V600 mutation or microsatellite instabilityhigh/deficient mismatch repair.

  • Prior treatment with a VEGF inhibitor, including bevacizumab or biosimilars.

  • Previous oxaliplatin treatment within 12 months prior to randomization, when armopen.

  • Known dihydropyrimidine dehydrogenase (DPD) deficiency.

  • Anticancer chemotherapy or biologic therapy administered within 28 days prior to thefirst dose of study drug.

  • Untreated or symptomatic brain metastasis.

  • Gastrointestinal (GI) disorder(s) that would significantly impede the absorption ofan oral agent.

  • Unable or unwilling to swallow study drug.

  • Uncontrolled intercurrent illness.

  • Known hypersensitivity to fluoropyrimidine or leucovorin, irinotecan, or oxalipatin.

  • Abnormal glucuronidation of bilirubin; known Gilbert's syndrome.

  • Use of strong CYP3A4 or CYP2C19 inhibitors or strong CYP3A4 inducers.

  • QTc >470

Study Design

Total Participants: 113
Treatment Group(s): 4
Primary Treatment: FOLFIRI
Phase: 2
Study Start date:
February 27, 2024
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • Mayo Clinic - Arizona

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • The University of Arizona Cancer Center

    Tucson, Arizona 85724
    United States

    Site Not Available

  • St. Bernards Medical Center

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • Highlands Oncology Group

    Springdale, Arkansas 72762
    United States

    Site Not Available

  • Pacific Cancer Medical Center

    Anaheim, California 92801
    United States

    Site Not Available

  • Comprehensive Blood and Cancer Center - Bakersfield

    Bakersfield, California 93309
    United States

    Site Not Available

  • Orange Coast Memorial Medical Center

    Fountain Valley, California 92708
    United States

    Site Not Available

  • UC San Diego Moores Cancer Center

    La Jolla, California 92037
    United States

    Site Not Available

  • Norris Comprehensive Cancer Center

    Los Angeles, California 90089
    United States

    Site Not Available

  • UCLA Department of Medicine-Hematology/Oncology

    Los Angeles, California 90095
    United States

    Site Not Available

  • Sharp Memorial Hospital

    San Diego, California 92123
    United States

    Site Not Available

  • Torrance Memorial Physician Network - Cancer Care and Infusion Center

    Torrance, California 90505
    United States

    Site Not Available

  • PIH Health

    Whittier, California 90602
    United States

    Site Not Available

  • Memorial Cancer Institute

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Mayo Clinic - Florida

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Cleveland Clinic Martin Health

    Stuart, Florida 34994
    United States

    Site Not Available

  • Kaiser Permanente

    Honolulu, Hawaii 96819
    United States

    Site Not Available

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • The University of Kansas Cancer Center - Westwood

    Westwood, Kansas 66205
    United States

    Site Not Available

  • Cancer Center of Kansas

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Mayo Clinic Cancer Center

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Saint Luke's Hospital

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Washington University School of Medicine Center for Advanced Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • CCCN

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • Manhattan Hematology Oncology (MHO) Research Foundation, Inc.

    New York, New York 10016
    United States

    Site Not Available

  • Trihealth Kenwood

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Lehigh Valley Health Network

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • West Cancer Clinic

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Oncology Consultants, PA

    Houston, Texas 77024
    United States

    Site Not Available

  • Utah Cancer Specialists

    Salt Lake City, Utah 84124
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Inova Schar Cancer Institute

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • VCU Massey Cancer Center

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Virginia Mason Medical Center

    Seattle, Washington 98101
    United States

    Site Not Available

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin 54911
    United States

    Site Not Available

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