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New pill plus chemo shows promise for Hard-to-Treat colon cancer

NCT ID NCT06106308

Disease control Sponsor: Cardiff Oncology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether adding an experimental drug called onvansertib to standard chemotherapy and bevacizumab can shrink tumors better than chemo alone in people with advanced colorectal cancer that has a KRAS or NRAS mutation. About 110 participants who have not had prior treatment for metastatic disease will receive either the new combination or standard therapy. The study aims to find the most effective dose and see if the combo improves response rates and delays cancer growth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Onvansertib (an experimental oral drug) combined with standard chemotherapy (FOLFIRI or FOLFOX) and bevacizumab
What this could lead to
If it works, this could offer a new first-line treatment option for people with a common genetic mutation in metastatic colorectal cancer, potentially improving tumor shrinkage and delaying disease progression.
What could go wrong
This is a mid-stage trial with only 110 participants, so results may not apply to everyone. Adding a new drug to standard chemo could increase side effects, and the benefit over current therapy is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

110 people

The number who actually took part.

Started

Feb 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. * Abnormal glucuronidation of bilirubin; known Gilbert's syndrome. * Use of strong CYP3A4 or CYP2C19 inhibitors or strong CYP3A4 inducers. * QTc \>470

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal carcinoma colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CRC KRAS/NRAS mutation Metastatic colorectal cancer

Contacts and locations

Locations

  • CCCN

    Las Vegas, Nevada, 89119, United States

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

    Grand Rapids, Michigan, 49503, United States

  • Cancer Center of Kansas

    Wichita, Kansas, 67214, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic Martin Health

    Stuart, Florida, 34994, United States

  • Comprehensive Blood and Cancer Center - Bakersfield

    Bakersfield, California, 93309, United States

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46804, United States

  • Highlands Oncology Group

    Springdale, Arkansas, 72762, United States

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • Kaiser Permanente

    Honolulu, Hawaii, 96819, United States

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

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

    New York, New York, 10016, United States

  • Mayo Clinic - Arizona

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic - Florida

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905, United States

  • Memorial Cancer Institute

    Hollywood, Florida, 33021, United States

  • Norris Comprehensive Cancer Center

    Los Angeles, California, 90089, United States

  • Oncology Consultants, PA

    Houston, Texas, 77024, United States

  • Orange Coast Memorial Medical Center

    Fountain Valley, California, 92708, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • PIH Health

    Whittier, California, 90602, United States

  • Pacific Cancer Medical Center

    Anaheim, California, 92801, United States

  • Saint Luke's Hospital

    Kansas City, Missouri, 64111, United States

  • Sharp Memorial Hospital

    San Diego, California, 92123, United States

  • St. Bernards Medical Center

    Jonesboro, Arkansas, 72401, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85724, United States

  • The University of Kansas Cancer Center - Westwood

    Westwood, Kansas, 66205, United States

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911, United States

  • Torrance Memorial Physician Network - Cancer Care and Infusion Center

    Torrance, California, 90505, United States

  • Trihealth Kenwood

    Cincinnati, Ohio, 45242, United States

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92037, United States

  • UCLA Department of Medicine-Hematology/Oncology

    Los Angeles, California, 90095, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84124, United States

  • VCU Massey Cancer Center

    Richmond, Virginia, 23298, United States

  • Virginia Mason Medical Center

    Seattle, Washington, 98101, United States

  • Washington University School of Medicine Center for Advanced Medicine

    St Louis, Missouri, 63110, United States

  • West Cancer Clinic

    Germantown, Tennessee, 38138, United States

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