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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