Clinical trial Recruiting at 44 sites Phase1; Phase2 Interventional Ages 18 and up

Amivantamab treatment for advanced colorectal cancer

Official title: 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

Run by Janssen Research & Development, LLC · NCT05379595 · Data updated 2026-11-12

This study is testing if a new drug called amivantamab, alone or with regular chemotherapy, can help people with advanced colorectal cancer.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment225 (estimated)
SponsorJanssen Research & Development, LLC
Industry-sponsored
Drugs / interventionsAmivantamab, chemotherapy
Locations53 sites (Birmingham, Alabama and 52 other locations)
StatusRecruiting
StartedJuly 29, 2022
Main results expectedApril 27, 2027
Study endsMay 11, 2031
Registry record updatedNovember 3, 2026
Trial IDNCT05379595 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals diagnosed with unresectable or metastatic adenocarcinoma of the colon or rectum who meet specific eligibility criteria.

Probably not a fit

Patients with resectable colorectal cancer or those who do not have measurable disease may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of amivantamab, both as a standalone treatment and in combination with standard chemotherapy, for patients with advanced or metastatic colorectal cancer. It aims to assess the anti-tumor activity and safety of amivantamab, a bispecific antibody targeting EGF and MET receptors, in various cohorts. Participants will undergo a screening period followed by treatment cycles, with safety monitored through physical exams and performance status assessments.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced colorectal cancer who have limited treatment choices.

How similar studies have gone: Previous studies have shown promise with similar bispecific antibody approaches, indicating potential for success in this novel application.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • University of California, Los Angeles UCLA
    Los Angeles, California, United States
    Recruiting
  • University of Michigan Health System
    Ann Arbor, Michigan, United States
    Recruiting
  • 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
  • Vanderbilt Ingram Cancer Center
    Nashville, Tennessee, United States
    Recruiting
Show 44 more locations
  • 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
  • The Ottawa Hospital Cancer Centre
    Ottawa, Ontario, Canada
    Recruiting
  • Princess Margaret Cancer Centre University Health Network
    Toronto, Ontario, Canada
    Recruiting
  • 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
  • O Neal Comprehensive Cancer Center at UAB
    Birmingham, Alabama, United States
    Completed
  • University of Southern California
    Los Angeles, California, United States
    Completed
  • 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
  • Start Midwest
    Grand Rapids, Michigan, United States
    Completed

+3 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.