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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 | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

A Phase 2, Randomized, Open-label 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 Patients With a KRAS or NRAS Mutation

NCT06106308•Cardiff Oncology

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 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

Exclusion Criteria

•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.
+3 more criteria

Locations (41)

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

Key Dates

Start Date

February 27, 2024

Primary Completion Date

November 1, 2026

Completion Date

January 1, 2027

Last Updated

January 12, 2026

Enrollment

113

ACTUAL participants

Conditions

Metastatic Colorectal CancerCRCKRAS/NRAS Mutation

Interventions

Onvansertib

DRUG

FOLFIRI

DRUG

Bevacizumab

DRUG

FOLFOX

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

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