RecruitingPhase 1Phase 2NCT05379595

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

Sponsor

Janssen Research & Development, LLC

Enrollment

225 participants

Start Date

Jul 29, 2022

Study Type

INTERVENTIONAL

Conditions

Advanced or Metastatic Colorectal Cancer

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called amivantamab — either alone or combined with chemotherapy — in patients with advanced or metastatic colorectal cancer whose tumors have specific genetic features (wild-type KRAS, NRAS, and BRAF, and no HER2 amplification). **You may be eligible if...** - You have been diagnosed with advanced or metastatic colorectal cancer (cancer of the colon or rectum) - Your tumor has been tested and has normal (wild-type) KRAS, NRAS, and BRAF genes, and no HER2 amplification - You have received 2–3 prior lines of treatment for metastatic disease (for monotherapy cohorts) or 1 prior line (for combination cohorts) - You are in generally good health **You may NOT be eligible if...** - Your tumor has KRAS, NRAS, or BRAF mutations, or HER2 amplification - You have not received the required number of prior treatments - Your organ function does not meet the study's requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAmivantamab IV

Amivantamab will be administered as intravenous infusion.

BIOLOGICALFluorouracil

Fluorouracil will be administered as intravenous infusion.

BIOLOGICALLeucovorin

Leucovorin will be administered as intravenous infusion.

BIOLOGICALOxaliplatin

Oxaliplatin will be administered as intravenous infusion.

BIOLOGICALIrinotecan

Irinotecan will be administered as intravenous infusion.

BIOLOGICALAmivantamab

Amivantamab will be administered.

Locations(53)

O Neal Comprehensive Cancer Center at UAB

Birmingham, Alabama, United States

University of Southern California

Los Angeles, California, United States

University of California, Los Angeles UCLA

Los Angeles, California, United States

Georgetown University Hospital

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

H Lee Moffitt Cancer Center

Tampa, Florida, United States

University of Maryland School of Medicine

Baltimore, Maryland, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Start Midwest

Grand Rapids, Michigan, United States

Hattiesburg Clinic

Hattiesburg, Mississippi, United States

NYU Langone Long Island Clinical Research Associates

New York, New York, United States

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, New York, United States

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, 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, British Columbia, Canada

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Princess Margaret Cancer Centre University Health Network

Toronto, Ontario, 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

View Full Details on ClinicalTrials.gov

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NCT05379595