Amivantamab Monotherapy in Chemorefractory RAS/BRAF Wild-Type Metastatic Colorectal Cancer: Results From OrigAMI-1, an Open-Label, Phase Ib/II Study.
Paul E Oberstein, J Randolph Hecht, Kanwal Raghav...
https://pubmed.ncbi.nlm.nih.gov/42013403Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID05379595
A Phase 1b/2 Study of Amivantamab Alone and with Standard Chemotherapy in Advanced or Metastatic Colorectal Cancer
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
225
Participants Needed
53
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the anti-tumor activity of amivantamab alone and combined with standard chemotherapy in people with advanced or metastatic colorectal cancer. This study aims to find the recommended dose of amivantamab when added to chemotherapy and to assess its safety in these patients. Colorectal cancer is a common global cancer, and amivantamab targets specific receptors involved in tumor growth and resistance to treatment. Participants will receive amivantamab as an intravenous infusion either by itself or with chemotherapy regimens like mFOLFOX6 or FOLFIRI. Treatment cycles last 28 days, with doses adjusted based on body weight and prior therapies. The study includes multiple groups: those receiving amivantamab alone, and those receiving it combined with chemotherapy, with dosing schedules starting from Cycle 1 Day 1 or Day -2 depending on the group. During the study, participants undergo physical exams, performance status assessments, lab tests, vital sign monitoring, and adverse event tracking. Tumor response will be measured using criteria like RECIST over up to 4 years and 3 months. Participants may also have tumor biopsies and pregnancy tests as needed. The study continues until treatment discontinuation, with follow-up visits up to 30 days after stopping treatment to monitor safety and outcomes.
CONDITIONS
Brief Title
A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Previously diagnosed with unresectable or metastatic adenocarcinoma of the colon or rectum confirmed by histology or cytology
- Tumor with wild-type KRAS, NRAS, BRAF, and no ERBB2/HER2 amplification
- For Cohorts A, B, and C: Received 2 to 3 prior systemic therapies for metastatic disease with specified chemotherapy and anti-VEGF treatment
- For Cohorts Ph1b-D, Ph1b-E, D, and E: No more than 1 prior systemic therapy for metastatic disease and eligible for specific chemotherapy regimens
- Cohort F: Treatment-naive for right-sided unresectable or metastatic CRC and eligible for mFOLFOX6 chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Tumor lesion suitable for biopsy and agreement to mandatory biopsy when required
- Female participants of childbearing potential must have negative pregnancy tests and agree to ongoing testing
- Measurable or evaluable disease as per criteria
You will not qualify if you...
- Identified mutations in KRAS, NRAS, BRAF, EGFR ectodomain, or ERBB2/HER2 amplification by ctDNA testing for most cohorts
- Cohort F: Additional exclusions include mutations in PTEN, ALK, ROS-1, RET, NTRK1 fusions, or MSI-H status
- Symptomatic or untreated brain metastases
- History or presence of leptomeningeal disease
- Any condition that could compromise participant well-being or interfere with study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - Up to 28 days
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - 28-day cycles until end of treatment
Participants receive study treatment including Amivantamab alone or in combination with standard chemotherapy regimens in repeated 28-day cycles until discontinuation.
Multiple infusion visits on specified cycle days depending on cohort assignment
Follow-up
Duration - Up to 30 days after discontinuation of study treatment
Participants are monitored for safety and adverse events after treatment ends, including physical exams and laboratory tests.
1 end of treatment visit and follow-up visits as needed
Trial Site Locations
Total: 53 locations
1
O Neal Comprehensive Cancer Center at UAB
Birmingham, Alabama, United States, 35233
Completed
2
University of Southern California
Los Angeles, California, United States, 90033
Completed
3
University of California, Los Angeles UCLA
Los Angeles, California, United States, 90404
Actively Recruiting
4
Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Completed
5
H Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
Completed
6
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Completed
7
University of Michigan Health System
Ann Arbor, Michigan, United States, 48103
Actively Recruiting
8
Start Midwest
Grand Rapids, Michigan, United States, 49546
Completed
9
Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
Actively Recruiting
10
NYU Langone Long Island Clinical Research Associates
New York, New York, United States, 10016
Actively Recruiting
11
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
12
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Active, Not Recruiting
13
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
14
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
15
Institut Jules Bordet
Anderlecht, Belgium, 1070
Actively Recruiting
16
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
Actively Recruiting
17
UZ Antwerpen
Edegem, Belgium, 2650
Actively Recruiting
18
Universitair Ziekenhuis Gasthuisberg
Leuven, Belgium, 3000
Actively Recruiting
19
BC Cancer Agency - Vancouver BC
Vancouver, British Columbia, Canada, V5Z 4E6
Completed
20
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
21
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, Canada, M5G 1X6
Actively Recruiting
22
The Second Hospital To Dalian Medical University
Dalian, China, 116023
Completed
23
Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
Guangzhou, China, 510655
Actively Recruiting
24
The Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, China, 310003
Actively Recruiting
25
Hubei province tumor hospital
Wuhan, China, 430079
Actively Recruiting
26
Asklepios Klinik Altona
Hamburg, Germany, 22763
Actively Recruiting
27
Ludwig-Maximilians-Universitaet Muenchen
Munich, Germany, 81377
Actively Recruiting
28
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
29
A O Ospedale Niguarda Ca Granda
Milan, Italy, 20162
Actively Recruiting
30
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56126
Actively Recruiting
31
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
32
Hospital Umum Sarawak
Kuching, Malaysia, 93586
Actively Recruiting
33
Beacon Hospital Sdn Bhd
Petaling Jaya, Malaysia, 46050
Actively Recruiting
34
Ad Vance Medical Research
Ponce, Puerto Rico, 00717
Actively Recruiting
35
Pan American Center for Oncology Trials LLC
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
36
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
37
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
38
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
39
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
40
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, South Korea, 06591
Actively Recruiting
41
Hosp Univ Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
42
Hosp. Gral. Univ. Gregorio Maranon
Madrid, Spain, 28007
Actively Recruiting
43
Hosp. Univ. Ramon Y Cajal
Madrid, Spain, 28034
Actively Recruiting
44
Hosp Univ Fund Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
45
Hosp Univ Hm Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
46
Hosp. Univ. Marques de Valdecilla
Santander, Spain, 39008
Actively Recruiting
47
Hosp. Clinico Univ. de Valencia
Valencia, Spain, 46010
Actively Recruiting
48
Changhua Christian Hospital
Changhua, Taiwan, 500
Actively Recruiting
49
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 83301
Actively Recruiting
50
Chi Mei Medical Center Liu Ying
Liou Ying Township, Taiwan, 736
Actively Recruiting
51
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Actively Recruiting
52
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
53
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan, 33305
Actively Recruiting
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Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Frequently Asked Questions
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