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

Running, not enrolling · Phase 2

Conditions studied: Metastatic Colorectal Cancer, CRC, KRAS/NRAS Mutation

In brief

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.

Key facts

Study ID

NCT06106308

Run by

Cardiff Oncology

People needed

110

Starts

2024-02-27

Expected to finish

2027-01-01

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 avoid pregnancy.
• Imaging computed tomography (CT) or magnetic resonance imaging (MRI) of chest/abdomen/pelvis and other scans as necessary to document all sites of disease performed within 28 days prior to the first dose of onvansertib.
• Must have acceptable organ function

You may not qualify if…

• Concomitant KRAS or NRAS and BRAF-V600 mutation or microsatellite instability high/deficient mismatch repair.
• Prior treatment with a VEGF inhibitor, including bevacizumab or biosimilars.
• Previous oxaliplatin treatment within 12 months prior to randomization, when arm open.
• Known dihydropyrimidine dehydrogenase (DPD) deficiency.
• Anticancer chemotherapy or biologic therapy administered within 28 days prior to the first dose of study drug.
• Untreated or symptomatic brain metastasis.
• Gastrointestinal (GI) disorder(s) that would significantly impede the absorption of an 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

Where it is running

• Mayo Clinic - Arizona — Phoenix, Arizona, United States
• The University of Arizona Cancer Center — Tucson, Arizona, United States
• St. Bernards Medical Center — Jonesboro, Arkansas, United States
• Highlands Oncology Group — Springdale, Arkansas, United States
• Pacific Cancer Medical Center — Anaheim, California, United States
• Comprehensive Blood and Cancer Center - Bakersfield — Bakersfield, California, United States
• Orange Coast Memorial Medical Center — Fountain Valley, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Norris Comprehensive Cancer Center — Los Angeles, California, United States
• UCLA Department of Medicine-Hematology/Oncology — Los Angeles, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• Torrance Memorial Physician Network - Cancer Care and Infusion Center — Torrance, California, United States
• PIH Health — Whittier, California, United States
• Memorial Cancer Institute — Hollywood, Florida, United States
• Mayo Clinic - Florida — Jacksonville, Florida, United States
• Cleveland Clinic Martin Health — Stuart, Florida, United States
• Kaiser Permanente — Honolulu, Hawaii, United States
• Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States
• The University of Kansas Cancer Center - Westwood — Westwood, Kansas, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion — Grand Rapids, Michigan, United States
• Mayo Clinic Cancer Center — Rochester, Minnesota, United States
• Saint Luke's Hospital — Kansas City, Missouri, United States
• Washington University School of Medicine Center for Advanced Medicine — St Louis, Missouri, United States
• CCCN — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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