Spots Global Cancer Trial Database for A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer
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Trial Identification
Brief Title: A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic 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
Study ID: NCT05379595
Conditions
Study Description
Brief Summary: The purpose of this study is to assess the anti-tumor activity of amivantamab as a monotherapy (Cohorts A, B, and C), to characterize the safety of amivantamab when added to standard-of care (SoC) chemotherapy in participants with metastatic colorectal cancer (mCRC) (Ph2 cohorts), and to assess the recommended phase 2 combination dose (RP2CD) of amivantamab when added to SoC chemotherapy (Ph1b 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 and E) 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. The total duration of this study will be up to 4 years 3 months.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, 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, Bruxelles, , 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, Da Lian Shi, , 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, Wu Han Shi, , China
Asklepios Klinik Altona, Hamburg, , Germany
Ludwig-Maximilians-Universitaet Muenchen, Munich, , Germany
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
A O Ospedale Niguarda Ca Granda, Milano, , Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, , Italy
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
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
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, , 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
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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