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New hope for colorectal cancer: amivantamab plus chemotherapy in clinical trial

NCT ID NCT05379595

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study is testing a drug called amivantamab, either alone or with standard chemotherapy, in people with advanced or metastatic colorectal cancer. The goal is to see if the combination can shrink tumors and to find the safest dose. About 225 participants will take part across multiple groups.

What this could mean

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

Active substance
amivantamab (RYBREVANT) and standard chemotherapy drugs (fluorouracil, leucovorin, oxaliplatin, irinotecan)
What this could lead to
If it works, this could offer a new treatment option for people with advanced colorectal cancer that hasn't responded to other therapies.
What could go wrong
This is an early-phase trial (phase 1b/2), so it's still testing safety and the right dose. It may not work for everyone, and side effects could be serious.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 225 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Oct 2030

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: * Participant must have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum * Participant must have tumor previously characterized as having wild-type Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), v-raf murine sarcoma viral oncogene homolog B (BRAF), and without evidence of Erb-b2 receptor tyrosine kinase 2/human epidermal growth factor receptor 2 (ERBB2/HER2) amplification. Additional cohort-specific requirements: * Phase (Ph) 2 (Cohorts A, B, and C) Amivantamab monotherapy: Participant must have received at least 2 but not more than 3 prior lines of systemic therapy in the metastatic setting. Participant must have been diagnosed with left-sided colorectal cancer (CRC) (Cohort A and B) and right-sided (Cohort C)and have received or been intolerant to standard of care (SoC) fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and an anti-vascular endothelial growth factor (VEGF) treatment. Participant must be anti-EGFR treatment naive in Cohort A, an anti-epidermal growth factor receptor (EGFR) treatment Cohort B, with or without an anti-EGFR treatment in Cohort C * Ph 1b Dose Confirmation Cohorts (Ph1b-D and Ph1b-E), Ph2 (Cohorts D and E) Amivantamab+mFOLFOX6/FOLFIRI: Participant must been diagnosed with CRC and have received no more than 1 prior line of systemic therapy in the metastatic setting. Cohort Ph1b-D/Cohort D: Participant must be anti-EGFR treatment naïve, have not received oxaliplatin-based chemotherapy in the metastatic setting, and be eligible for treatment with mFOLFOX6 according to local regulatory approvals and SoC guidelines. Cohort Ph1b-E/Cohort E: Participant must be anti-EGFR treatment naïve, have not received irinotecan-based chemotherapy in the metastatic setting, and be eligible for treatment with FOLFIRI according to local regulatory approvals and SoC guidelines * Ph2 Cohorts F Amivantamab subcutaneous (SC) + mFOLFOX6: Participants must be treatment-naive for right-sided unresectable or metastatic CRC and be eligible for treatment with mFOLFOX6 according to local regulatory approvals and SoC guidelines * For Phase 1 dose confirmation cohorts (Cohorts Ph1b-D and Ph1b-E): Participant must have evaluable disease. For Phase 2: Participant must have measurable disease according to Response Criteria in Solid Tumors (RECIST) Version 1.1. If only one measurable lesion exists, it may be used for the screening biopsy as long as baseline tumor assessment scans are performed greater than or equal to (\>=) 7 days after the biopsy * Participant must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 * Participant must have a tumor lesion amenable for biopsy and agree to mandatory protocol-defined screening biopsy. Biopsies are required if clinically feasible for participants in Ph1b-D, Ph1b-E, and Cohort F. For Cohort F, archival tissue is required if a fresh biopsy is not feasible * A female participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study. Note: Participant must not be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study Exclusion Criteria: * Cohorts A, B, C, Ph1b-D, D, Ph1b-E, and E: Participant with identified mutation in Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), v-raf murine sarcoma viral oncogene homolog B (BRAF), or epidermal growth factor receptor (EGFR) ectodomain, or ERBB2/HER2 amplification by central circulating tumor deoxyribonucleic acid (ctDNA) testing at screening; Cohort F: Participant with identified mutation in KRAS, NRAS, BRAF V600, or PTEN, identified fusions in ALK, ROS-1, RET, and NTRK 1, ERBB2/HER2 amplification, or identified to have MSI-H status by central ctDNA testing at screening * Participant with symptomatic or untreated brain metastasis * History or known presence of leptomeningeal disease * Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments

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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.

Advanced or metastatic colorectal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    44 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A O Ospedale Niguarda Ca Granda

    RECRUITING

    Milan, 20162, Italy

  • Ad Vance Medical Research

    RECRUITING

    Ponce, 00717, Puerto Rico

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Asklepios Klinik Altona

    RECRUITING

    Hamburg, 22763, Germany

  • Azienda Ospedaliero Universitaria Pisana

    RECRUITING

    Pisa, 56126, Italy

  • BC Cancer Agency - Vancouver BC

    COMPLETED

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Beacon Hospital Sdn Bhd

    RECRUITING

    Petaling Jaya, 46050, Malaysia

  • Changhua Christian Hospital

    RECRUITING

    Changhua, 500, Taiwan

  • Chi Mei Medical Center Liu Ying

    RECRUITING

    Liou Ying Township, 736, Taiwan

  • Cliniques Universitaires Saint Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    RECRUITING

    Milan, 20133, Italy

  • Georgetown University Hospital

    COMPLETED

    Washington D.C., District of Columbia, 20007, United States

  • H Lee Moffitt Cancer Center

    COMPLETED

    Tampa, Florida, 33612, United States

  • Hattiesburg Clinic

    RECRUITING

    Hattiesburg, Mississippi, 39401, United States

  • Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Hosp Univ Fund Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • Hosp Univ Hm Sanchinarro

    RECRUITING

    Madrid, 28050, Spain

  • Hosp Univ Vall D Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hosp. Clinico Univ. de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hosp. Gral. Univ. Gregorio Maranon

    RECRUITING

    Madrid, 28009, Spain

  • Hosp. Univ. Marques de Valdecilla

    RECRUITING

    Santander, 39008, Spain

  • Hosp. Univ. Ramon Y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Umum Sarawak

    RECRUITING

    Kuching, 93586, Malaysia

  • Hubei province tumor hospital

    RECRUITING

    Wuhan, 430079, China

  • Institut Jules Bordet

    RECRUITING

    Anderlecht, 1070, Belgium

  • Kaohsiung Chang Gung Memorial Hospital

    RECRUITING

    Kaohsiung City, 83301, Taiwan

  • Linkou Chang Gung Memorial Hospital

    RECRUITING

    Taoyuan, 33305, Taiwan

  • Ludwig-Maximilians-Universitaet Muenchen

    RECRUITING

    Munich, 81377, Germany

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • NYU Langone Long Island Clinical Research Associates

    RECRUITING

    New York, New York, 10016, United States

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 10002, Taiwan

  • O Neal Comprehensive Cancer Center at UAB

    COMPLETED

    Birmingham, Alabama, 35233, United States

  • Pan American Center for Oncology Trials LLC

    RECRUITING

    Rio Piedras, 00935, Puerto Rico

  • Princess Margaret Cancer Centre University Health Network

    RECRUITING

    Toronto, Ontario, M5G 1X6, Canada

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Start Midwest

    COMPLETED

    Grand Rapids, Michigan, 49546, United States

  • Stephenson Cancer Center

    COMPLETED

    Oklahoma City, Oklahoma, 73104, United States

  • Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital

    RECRUITING

    Guangzhou, 510655, China

  • The Catholic University of Korea Seoul St Mary s Hospital

    RECRUITING

    Seoul, 06591, South Korea

  • The Ottawa Hospital Cancer Centre

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • The Second Affiliated Hospital of Zhejiang University College of Medicine

    RECRUITING

    Hangzhou, 310003, China

  • The Second Hospital To Dalian Medical University

    COMPLETED

    Dalian, 116023, China

  • UZ Antwerpen

    RECRUITING

    Edegem, 2650, Belgium

  • Universitair Ziekenhuis Gasthuisberg

    RECRUITING

    Leuven, 3000, Belgium

  • University Malaya Medical Centre

    RECRUITING

    Kuala Lumpur, 59100, Malaysia

  • University of California, Los Angeles UCLA

    RECRUITING

    Los Angeles, California, 90404, United States

  • University of Maryland School of Medicine

    COMPLETED

    Baltimore, Maryland, 21201, United States

  • University of Michigan Health System

    RECRUITING

    Ann Arbor, Michigan, 48103, United States

  • University of Southern California

    COMPLETED

    Los Angeles, California, 90033, United States

  • Vanderbilt Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232, United States