A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer (OrigAMI-1)
Last Updated March 5, 2025
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CR109215
OVERVIEW
-
Sexes Eligible for Study
all -
Age
years -
Phase
phase 11 -
Sites
Sites -
Status
Recruiting
SUMMARY
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.
CONDITIONS
- Advanced or Metastatic Colorectal Cancer
ELIGIBILITY
Inclusion Criteria:
* Participant must have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum
* For Phase 1 dose confirmation cohorts (Cohorts Ph1b-D and Ph1b-E): Participant must have evaluab
DETAILS
LOCATIONS
Locations in:
United States, Belgium, Canada, China, Germany, Italy, South Korea, Malaysia, Puerto Rico, Spain, Taiwan
| Country (11) | City or Province (53) | Status |
| United States | Birmingham O Neal Comprehensive Cancer Center at UAB |
RECRUITING
|
| United States | Los Angeles University of California, Los Angeles UCLA |
RECRUITING
|
| United States | Washington Georgetown University Hospital |
RECRUITING
|
| United States | Baltimore University of Maryland School of Medicine |
RECRUITING
|
| United States | Ann Arbor University of Michigan Health System |
RECRUITING
|
| United States | Grand Rapids Start Midwest |
RECRUITING
|
| United States | Hattiesburg Hattiesburg Clinic |
RECRUITING
|
| United States | New York NYU Langone Long Island Clinical Research Associates |
RECRUITING
|
| United States | New York Herbert Irving Comprehensive Cancer Center Columbia University Medical Center |
RECRUITING
|
| United States | Oklahoma City Stephenson Cancer Center |
RECRUITING
|
| United States | Nashville Vanderbilt Ingram Cancer Center |
RECRUITING
|
| United States | Houston MD Anderson Cancer Center |
RECRUITING
|
| Belgium | Anderlecht Institut Jules Bordet |
RECRUITING
|
| Belgium | Bruxelles Cliniques Universitaires Saint Luc |
RECRUITING
|
| Belgium | Edegem UZ Antwerpen |
RECRUITING
|
| Belgium | Leuven Universitair Ziekenhuis Gasthuisberg |
RECRUITING
|
| Canada | Vancouver BC Cancer Agency - Vancouver BC |
RECRUITING
|
| Canada | Ottawa The Ottawa Hospital Cancer Centre |
RECRUITING
|
| Canada | Toronto Princess Margaret Cancer Centre University Health Network |
RECRUITING
|
| China | Da Lian Shi The Second Hospital To Dalian Medical University |
RECRUITING
|
| China | Guangzhou Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital |
RECRUITING
|
| China | Hangzhou The Second Affiliated Hospital of Zhejiang University College of Medicine |
RECRUITING
|
| China | Wu Han Shi Hubei province tumor hospital |
RECRUITING
|
| Germany | Hamburg Asklepios Klinik Altona |
RECRUITING
|
| Germany | Munich Ludwig-Maximilians-Universitaet Muenchen |
RECRUITING
|
| Italy | Milano Fondazione IRCCS Istituto Nazionale dei Tumori |
RECRUITING
|
| Italy | Milano A O Ospedale Niguarda Ca Granda |
RECRUITING
|
| Italy | Pisa Azienda Ospedaliero Universitaria Pisana |
RECRUITING
|
| South Korea | Seoul Seoul National University Hospital |
RECRUITING
|
| South Korea | Seoul Severance Hospital Yonsei University Health System |
RECRUITING
|
| South Korea | Seoul Asan Medical Center |
RECRUITING
|
| South Korea | Seoul Samsung Medical Center |
RECRUITING
|
| South Korea | Seoul The Catholic University of Korea Seoul St Mary s Hospital |
RECRUITING
|
| Malaysia | Kuala Lumpur University Malaya Medical Centre |
RECRUITING
|
| Malaysia | Kuching Hospital Umum Sarawak |
RECRUITING
|
| Malaysia | Petaling Jaya Beacon Hospital Sdn Bhd |
RECRUITING
|
| Puerto Rico | Ponce Ad Vance Medical Research |
RECRUITING
|
| Puerto Rico | Rio Piedras Pan American Center for Oncology Trials LLC |
RECRUITING
|
| Spain | Barcelona Hosp Univ Vall D Hebron |
RECRUITING
|
| Spain | Madrid Hosp. Gral. Univ. Gregorio Maranon |
RECRUITING
|
| Spain | Madrid Hosp. Univ. Ramon Y Cajal |
RECRUITING
|
| Spain | Madrid Hosp Univ Fund Jimenez Diaz |
RECRUITING
|
| Spain | Madrid Hosp Univ Hm Sanchinarro |
RECRUITING
|
| Spain | Santander Hosp. Univ. Marques de Valdecilla |
RECRUITING
|
| Spain | Valencia Hosp. Clinico Univ. de Valencia |
RECRUITING
|
| Taiwan | Changhua Changhua Christian Hospital |
RECRUITING
|
| Taiwan | Kaohsiung Kaohsiung Chang Gung Memorial Hospital |
RECRUITING
|
| Taiwan | Liou Ying Township Chi Mei Medical Center Liu Ying |
RECRUITING
|
| Taiwan | Tainan National Cheng Kung University Hospital |
RECRUITING
|
| Taiwan | Taipei National Taiwan University Hospital |
RECRUITING
|
| Taiwan | Taoyuan Linkou Chang Gung Memorial Hospital |
RECRUITING
|
| United States | Los Angeles University of Southern California |
COMPLETED
|
| United States | Tampa H Lee Moffitt Cancer Center |
COMPLETED
|
Geo Locations
33.52066, -86.80249
34.05223, -118.24368
38.89511, -77.03637
39.29038, -76.61219
42.27756, -83.74088
42.96336, -85.66809
31.32712, -89.29034
40.71427, -74.00597
40.71427, -74.00597
35.46756, -97.51643
36.16589, -86.78444
29.76328, -95.36327
50.83619, 4.31454
50.85045, 4.34878
51.15662, 4.44504
50.87959, 4.70093
49.24966, -123.11934
45.41117, -75.69812
43.70011, -79.4163
38.8852299, 121.5831
23.11667, 113.25
30.29365, 120.16142
30.5081999, 114.397
53.57532, 10.01534
48.13743, 11.57549
45.46427, 9.18951
45.46427, 9.18951
43.70853, 10.4036
37.566, 126.9784
37.566, 126.9784
37.566, 126.9784
37.566, 126.9784
37.566, 126.9784
3.1412, 101.68653
1.54999, 110.33333
3.10726, 101.60671
18.01108, -66.61406
18.39745, -66.04989
41.38879, 2.15899
40.4165, -3.70256
40.4165, -3.70256
40.4165, -3.70256
40.4165, -3.70256
43.46472, -3.80444
39.46975, -0.37739
24.07327, 120.56276
22.61626, 120.31333
23.2806957, 120.3550808
22.99083, 120.21333
25.04776, 121.53185
24.95233, 121.20193
34.05223, -118.24368
27.94752, -82.45843
x
50
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10
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5
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Corresponds to individual site.