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NCT05379595From ClinicalTrials.govRecruiting

A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer

A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer

  • Advanced or Metastatic Colorectal Cancer

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Janssen Research & Development, LLC
Enrolment target
225
Started
29 July 2022
Main results due
27 April 2027
Study sites
53
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

The purpose of this study is to assess the anti-tumor activity of amivantamab as a monotherapy (Cohorts A, B, and C), to assess the recommended phase 2 combination dose (RP2CD) of amivantamab when added to SoC chemotherapy (Ph1b cohorts) and to characterize the safety of amivantamab when added to standard-of care (SoC) chemotherapy in participants with metastatic colorectal cancer (mCRC) (Ph2 cohorts).

Study sites(53)

  • O Neal Comprehensive Cancer Center at UAB

    Birmingham, Alabama, United States

    Completed

  • University of Southern California

    Los Angeles, California, United States

    Completed

  • University of California, Los Angeles UCLA

    Los Angeles, California, United States

    Recruiting

  • Georgetown University Hospital

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

    Completed

  • H Lee Moffitt Cancer Center

    Tampa, Florida, United States

    Completed

  • University of Maryland School of Medicine

    Baltimore, Maryland, United States

    Completed

  • University of Michigan Health System

    Ann Arbor, Michigan, United States

    Recruiting

  • Start Midwest

    Grand Rapids, Michigan, United States

    Completed

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, United States

    Recruiting

  • NYU Langone Long Island Clinical Research Associates

    New York, New York, United States

    Recruiting

  • Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

    New York, New York, United States

    Recruiting

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, United States

    Completed

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee, United States

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, United States

    Recruiting

  • Institut Jules Bordet

    Anderlecht, Belgium

    Recruiting

  • Cliniques Universitaires Saint Luc

    Brussels, Belgium

    Recruiting

  • UZ Antwerpen

    Edegem, Belgium

    Recruiting

  • Universitair Ziekenhuis Gasthuisberg

    Leuven, Belgium

    Recruiting

  • BC Cancer Agency - Vancouver BC

    Vancouver, British Columbia, Canada

    Completed

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, Canada

    Recruiting

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario, Canada

    Recruiting

  • The Second Hospital To Dalian Medical University

    Dalian, China

    Completed

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

    Guangzhou, China

    Recruiting

  • The Second Affiliated Hospital of Zhejiang University College of Medicine

    Hangzhou, China

    Recruiting

  • Hubei province tumor hospital

    Wuhan, China

    Recruiting

  • Asklepios Klinik Altona

    Hamburg, Germany

    Recruiting

  • Ludwig-Maximilians-Universitaet Muenchen

    Munich, Germany

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Italy

    Recruiting

  • A O Ospedale Niguarda Ca Granda

    Milan, Italy

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Italy

    Recruiting

  • University Malaya Medical Centre

    Kuala Lumpur, Malaysia

    Recruiting

  • Hospital Umum Sarawak

    Kuching, Malaysia

    Recruiting

  • Beacon Hospital Sdn Bhd

    Petaling Jaya, Malaysia

    Recruiting

  • Ad Vance Medical Research

    Ponce, Puerto Rico

    Recruiting

  • Pan American Center for Oncology Trials LLC

    Rio Piedras, Puerto Rico

    Recruiting

  • Seoul National University Hospital

    Seoul, South Korea

    Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, South Korea

    Recruiting

  • Asan Medical Center

    Seoul, South Korea

    Recruiting

  • Samsung Medical Center

    Seoul, South Korea

    Recruiting

  • The Catholic University of Korea Seoul St Mary s Hospital

    Seoul, South Korea

    Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, Spain

    Recruiting

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, Spain

    Recruiting

  • Hosp. Univ. Ramon Y Cajal

    Madrid, Spain

    Recruiting

  • Hosp Univ Fund Jimenez Diaz

    Madrid, Spain

    Recruiting

  • Hosp Univ Hm Sanchinarro

    Madrid, Spain

    Recruiting

  • Hosp. Univ. Marques de Valdecilla

    Santander, Spain

    Recruiting

  • Hosp. Clinico Univ. de Valencia

    Valencia, Spain

    Recruiting

  • Changhua Christian Hospital

    Changhua, Taiwan

    Recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, Taiwan

    Recruiting

  • Chi Mei Medical Center Liu Ying

    Liou Ying Township, Taiwan

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, Taiwan

    Recruiting

  • National Taiwan University Hospital

    Taipei, Taiwan

    Recruiting

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, Taiwan

    Recruiting

Showing 53 of 53 sites. 44 of the 53 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05379595. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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