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A 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
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).
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
225
Start Date
2022-07-29
Completion Date
2030-10-31
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
Amivantamab IV
Amivantamab will be administered as intravenous infusion.
Fluorouracil
Fluorouracil will be administered as intravenous infusion.
Leucovorin
Leucovorin will be administered as intravenous infusion.
Oxaliplatin
Oxaliplatin will be administered as intravenous infusion.
Irinotecan
Irinotecan will be administered as intravenous infusion.
Amivantamab
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 District, Taiwan