A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer
Start Date
7/29/2022
Completion Date
10/31/2030
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).
Detailed Description
Colorectal cancer (CRC) is a major global health concern and the third most common cancer worldwide. Amivantamab (also known as RYBREVANT or JNJ-61186372) is a fully human immunoglobulin (Ig) G1-based bispecific antibody (Ab) directed against the epidermal growth factor (EGF) and mesenchymal epithelial transition (MET) receptors, with evidence of preclinical activity against non-small cell lung cancer (NSCLC) tumors with activating EGF receptor (EGFR) mutations, the T790M and C797S second-site resistance EGFR mutations, overexpressed wild-type EGFR, as well as with activation of the MET pathway. Amivantamab has demonstrated activity in both EGFR- and MET-driven NSCLC, with preclinical evidence demonstrating its ability to recruit immune effector cells. While two anti-EGFR antibodies are incorporated as part of the SoC for CRC patients, MET is highly expressed or amplified in subsets of CRC and additionally plays a role in mediating resistance to anti-EGFR treatments. The study consists of up to 28 days screening period, treatment period will begin on Cycle 1 Day 1 (C1D1) (for Cohorts A, B, and C) or C1D -2 (for Ph1b-D, Ph1b-E, Cohorts D, E and F) with the administration of the study treatment and continue as 28-day cycles until the end of treatment visit, up to 30 days after discontinuation of study treatment. The safety of amivantamab as a monotherapy or in addition to SoC chemotherapy will be assessed by physical examinations, Eastern Cooperative Oncology Group (ECOG) criteria for performance status (PS), laboratory tests, vital signs, monitoring of adverse events, and concomitant medication usage.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Amivantamab IV
Fluorouracil
Leucovorin
Oxaliplatin
Irinotecan
Amivantamab
Conditions
Locations
O Neal Comprehensive Cancer Center at UAB
Birmingham, Alabama 35233
United States
University of Southern California
Los Angeles, California 90033
United States
University of California, Los Angeles UCLA
Los Angeles, California 90404
United States
Georgetown University Hospital
Washington D.C., District of Columbia 20007
United States
H Lee Moffitt Cancer Center
Tampa, Florida 33612
United States
University of Maryland School of Medicine
Baltimore, Maryland 21201
United States
University of Michigan Health System
Ann Arbor, Michigan 48103
United States
Start Midwest
Grand Rapids, Michigan 49546
United States
Hattiesburg Clinic
Hattiesburg, Mississippi 39401
United States
NYU Langone Long Island Clinical Research Associates
New York, New York 10016
United States
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York 10032
United States
Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee 37232
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Institut Jules Bordet
Anderlecht, 1070
Belgium
Cliniques Universitaires Saint Luc
Brussels, 1200
Belgium
UZ Antwerpen
Edegem, 2650
Belgium
Universitair Ziekenhuis Gasthuisberg
Leuven, 3000
Belgium
BC Cancer Agency - Vancouver BC
Vancouver, British Columbia V5Z 4E6
Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario K1H 8L6
Canada
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario M5G 1X6
Canada
The Second Hospital To Dalian Medical University
Dalian, 116023
China
Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
Guangzhou, 510655
China
The Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, 310003
China
Hubei province tumor hospital
Wuhan, 430079
China
Asklepios Klinik Altona
Hamburg, 22763
Germany
Ludwig-Maximilians-Universitaet Muenchen
Munich, 81377
Germany
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Italy
A O Ospedale Niguarda Ca Granda
Milan, 20162
Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Italy
University Malaya Medical Centre
Kuala Lumpur, 59100
Malaysia
Hospital Umum Sarawak
Kuching, 93586
Malaysia
Beacon Hospital Sdn Bhd
Petaling Jaya, 46050
Malaysia
Ad Vance Medical Research
Ponce, 00717
Puerto Rico
Pan American Center for Oncology Trials LLC
Rio Piedras, 00935
Puerto Rico
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, 06591
South Korea
Hosp Univ Vall D Hebron
Barcelona, 08035
Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007
Spain
Hosp. Univ. Ramon Y Cajal
Madrid, 28034
Spain
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
Spain
Hosp Univ Hm Sanchinarro
Madrid, 28050
Spain
Hosp. Univ. Marques de Valdecilla
Santander, 39008
Spain
Hosp. Clinico Univ. de Valencia
Valencia, 46010
Spain
Changhua Christian Hospital
Changhua, 500
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Taiwan
Chi Mei Medical Center Liu Ying
Liou Ying Township, 736
Taiwan
National Cheng Kung University Hospital
Tainan, 704
Taiwan
National Taiwan University Hospital
Taipei, 10002
Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, 33305
Taiwan