RecruitingPhase I/IIEN originalColorectal cancerMetastatic / advanced

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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).

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Pacjent musi mieć potwierdzony rak jelita grubego lub odbytnicy, którego nie da się operacyjnie usunąć lub który dał przerzuty.
  • Guz pacjenta musi mieć określony, 'prawidłowy' typ genów (KRAS, NRAS, BRAF) i nie może wykazywać nadmiernego wzrostu białka HER2.
  • W przypadku leczenia samym amivantamabem (Grupa A, B, C): Pacjent musiał wcześniej przejść od 2 do 3 linii leczenia.
  • Pacjent w tej grupie musiał otrzymać lub nie tolerować standardowego leczenia chemioterapią (z użyciem fluoropirymidyny, oksaliplatyny, irinotekanu) oraz leku przeciw VEGF.
  • W przypadku leczenia amivantamabem w połączeniu z chemioterapią (Grupa D, E): Pacjent musiał otrzymać nie więcej niż 1 linię leczenia dotychczas.
  • Pacjent musi kwalifikować się do standardowego leczenia chemioterapią (mFOLFOX6 lub FOLFIRI) zgodnie z wytycznymi.

✗ Disqualifies

  • Pacjent, który wcześniej otrzymał pewne rodzaje terapii (np. leki anty-EGFR, chemioterapię na bazie oksaliplatyny lub irinotekanu, w zależności od badanej grupy) może nie kwalifikować się do udziału.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 6, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (53)

O Neal Comprehensive Cancer Center at UAB

Birmingham, United States

University of Southern California

Los Angeles, United States

University of California, Los Angeles UCLA

Los Angeles, United States

Georgetown University Hospital

Washington D.C., United States

H Lee Moffitt Cancer Center

Tampa, United States

University of Maryland School of Medicine

Baltimore, United States

University of Michigan Health System

Ann Arbor, United States

Start Midwest

Grand Rapids, United States

Hattiesburg Clinic

Hattiesburg, United States

NYU Langone Long Island Clinical Research Associates

New York, United States

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, United States

Stephenson Cancer Center

Oklahoma City, United States

Vanderbilt Ingram Cancer Center

Nashville, United States

MD Anderson Cancer Center

Houston, United States

Institut Jules Bordet

Anderlecht, Belgium

Cliniques Universitaires Saint Luc

Brussels, Belgium

UZ Antwerpen

Edegem, Belgium

Universitair Ziekenhuis Gasthuisberg

Leuven, Belgium

BC Cancer Agency - Vancouver BC

Vancouver, Canada

The Ottawa Hospital Cancer Centre

Ottawa, Canada

Princess Margaret Cancer Centre University Health Network

Toronto, Canada

The Second Hospital To Dalian Medical University

Dalian, China

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

Guangzhou, China

The Second Affiliated Hospital of Zhejiang University College of Medicine

Hangzhou, China

Hubei province tumor hospital

Wuhan, China

Asklepios Klinik Altona

Hamburg, Germany

Ludwig-Maximilians-Universitaet Muenchen

Munich, Germany

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

A O Ospedale Niguarda Ca Granda

Milan, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Hospital Umum Sarawak

Kuching, Malaysia

Beacon Hospital Sdn Bhd

Petaling Jaya, Malaysia

Ad Vance Medical Research

Ponce, Puerto Rico

Pan American Center for Oncology Trials LLC

Rio Piedras, Puerto Rico

Seoul National University Hospital

Seoul, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, South Korea

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, Spain

Hosp. Univ. Ramon Y Cajal

Madrid, Spain

Hosp Univ Fund Jimenez Diaz

Madrid, Spain

Hosp Univ Hm Sanchinarro

Madrid, Spain

Hosp. Univ. Marques de Valdecilla

Santander, Spain

Hosp. Clinico Univ. de Valencia

Valencia, Spain

Changhua Christian Hospital

Changhua, Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Chi Mei Medical Center Liu Ying

Liou Ying Township, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/7/2026.

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