Amivantamab treatment for advanced 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
Run by Janssen Research & Development, LLC · NCT05379595 · Data updated 2026-11-12
This study is testing if a new drug called amivantamab, alone or with regular chemotherapy, can help people with advanced colorectal cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 225 (estimated) |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | Amivantamab, chemotherapy |
| Locations | 53 sites (Birmingham, Alabama and 52 other locations) |
| Status | Recruiting |
| Started | July 29, 2022 |
| Main results expected | April 27, 2027 |
| Study ends | May 11, 2031 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT05379595 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals diagnosed with unresectable or metastatic adenocarcinoma of the colon or rectum who meet specific eligibility criteria.
✕Probably not a fit
Patients with resectable colorectal cancer or those who do not have measurable disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of amivantamab, both as a standalone treatment and in combination with standard chemotherapy, for patients with advanced or metastatic colorectal cancer. It aims to assess the anti-tumor activity and safety of amivantamab, a bispecific antibody targeting EGF and MET receptors, in various cohorts. Participants will undergo a screening period followed by treatment cycles, with safety monitored through physical exams and performance status assessments.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced colorectal cancer who have limited treatment choices.
How similar studies have gone: Previous studies have shown promise with similar bispecific antibody approaches, indicating potential for success in this novel application.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant must have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum * Participant must have tumor previously characterized as having wild-type Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), v-raf murine sarcoma viral oncogene homolog B (BRAF), and without evidence of Erb-b2 receptor tyrosine kinase 2/human epidermal growth factor receptor 2 (ERBB2/HER2) amplification. Additional cohort-specific requirements: * Phase (Ph) 2 (Cohorts A, B, and C) Amivantamab monotherapy: Participant must have received at least 2 but not more than 3 prior lines of systemic therapy in the metastatic setting. Participant must have been diagnosed with left-sided colorectal cancer (CRC) (Cohort A and B) and right-sided (Cohort C)and have received or been intolerant to standard of care (SoC) fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and an anti-vascular endothelial growth factor (VEGF) treatment. Participant must be anti-EGFR treatment naive in Cohort A, an anti-epidermal growth factor receptor (EGFR) treatment Cohort B, with or without an anti-EGFR treatment in Cohort C * Ph 1b Dose Confirmation Cohorts (Ph1b-D and Ph1b-E), Ph2 (Cohorts D and E) Amivantamab+mFOLFOX6/FOLFIRI: Participant must been diagnosed with CRC and have received no more than 1 prior line of systemic therapy in the metastatic setting. Cohort Ph1b-D/Cohort D: Participant must be anti-EGFR treatment naïve, have not received oxaliplatin-based chemotherapy in the metastatic setting, and be eligible for treatment with mFOLFOX6 according to local regulatory approvals and SoC guidelines. Cohort Ph1b-E/Cohort E: Participant must be anti-EGFR treatment naïve, have not received irinotecan-based chemotherapy in the metastatic setting, and be eligible for treatment with FOLFIRI according to local regulatory approvals and SoC guidelines * Ph2 Cohorts F Amivantamab subcutaneous (SC) + mFOLFOX6: Participants must be treatment-naive for right-sided unresectable or metastatic CRC and be eligible for treatment with mFOLFOX6 according to local regulatory approvals and SoC guidelines * For Phase 1 dose confirmation cohorts (Cohorts Ph1b-D and Ph1b-E): Participant must have evaluable disease. For Phase 2: Participant must have measurable disease according to Response Criteria in Solid Tumors (RECIST) Version 1.1. If only one measurable lesion exists, it may be used for the screening biopsy as long as baseline tumor assessment scans are performed greater than or equal to (\>=) 7 days after the biopsy * Participant must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 * Participant must have a tumor lesion amenable for biopsy and agree to mandatory protocol-defined screening biopsy. Biopsies are required if clinically feasible for participants in Ph1b-D, Ph1b-E, and Cohort F. For Cohort F, archival tissue is required if a fresh biopsy is not feasible * A female participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study. Note: Participant must not be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study Exclusion Criteria: * Cohorts A, B, C, Ph1b-D, D, Ph1b-E, and E: Participant with identified mutation in Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), v-raf murine sarcoma viral oncogene homolog B (BRAF), or epidermal growth factor receptor (EGFR) ectodomain, or ERBB2/HER2 amplification by central circulating tumor deoxyribonucleic acid (ctDNA) testing at screening; Cohort F: Participant with identified mutation in KRAS, NRAS, BRAF V600, or PTEN, identified fusions in ALK, ROS-1, RET, and NTRK 1, ERBB2/HER2 amplification, or identified to have MSI-H status by central ctDNA testing at screening * Participant with symptomatic or untreated brain metastasis * History or known presence of leptomeningeal disease * Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Where it's running
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University of California, Los Angeles UCLA
Los Angeles, California, United States Recruiting -
University of Michigan Health System
Ann Arbor, Michigan, United States Recruiting -
Hattiesburg Clinic
Hattiesburg, Mississippi, United States Recruiting -
NYU Langone Long Island Clinical Research Associates
New York, New York, United States Recruiting -
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, United States Recruiting -
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States Recruiting
Show 44 more locations
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MD Anderson Cancer Center
Houston, Texas, United States Recruiting -
Institut Jules Bordet
Anderlecht, Belgium Recruiting -
Cliniques Universitaires Saint Luc
Brussels, Belgium Recruiting -
UZ Antwerpen
Edegem, Belgium Recruiting -
Universitair Ziekenhuis Gasthuisberg
Leuven, Belgium Recruiting -
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada Recruiting -
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, Canada Recruiting -
Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
Guangzhou, China Recruiting -
The Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, China Recruiting -
Hubei province tumor hospital
Wuhan, China Recruiting -
Asklepios Klinik Altona
Hamburg, Germany Recruiting -
Ludwig-Maximilians-Universitaet Muenchen
Munich, Germany Recruiting -
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy Recruiting -
A O Ospedale Niguarda Ca Granda
Milan, Italy Recruiting -
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy Recruiting -
University Malaya Medical Centre
Kuala Lumpur, Malaysia Recruiting -
Hospital Umum Sarawak
Kuching, Malaysia Recruiting -
Beacon Hospital Sdn Bhd
Petaling Jaya, Malaysia Recruiting -
Ad Vance Medical Research
Ponce, Puerto Rico Recruiting -
Pan American Center for Oncology Trials LLC
Rio Piedras, Puerto Rico Recruiting -
Seoul National University Hospital
Seoul, South Korea Recruiting -
Severance Hospital Yonsei University Health System
Seoul, South Korea Recruiting -
Asan Medical Center
Seoul, South Korea Recruiting -
Samsung Medical Center
Seoul, South Korea Recruiting -
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, South Korea Recruiting -
Hosp Univ Vall D Hebron
Barcelona, Spain Recruiting -
Hosp. Gral. Univ. Gregorio Maranon
Madrid, Spain Recruiting -
Hosp. Univ. Ramon Y Cajal
Madrid, Spain Recruiting -
Hosp Univ Fund Jimenez Diaz
Madrid, Spain Recruiting -
Hosp Univ Hm Sanchinarro
Madrid, Spain Recruiting -
Hosp. Univ. Marques de Valdecilla
Santander, Spain Recruiting -
Hosp. Clinico Univ. de Valencia
Valencia, Spain Recruiting -
Changhua Christian Hospital
Changhua, Taiwan Recruiting -
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan Recruiting -
Chi Mei Medical Center Liu Ying
Liou Ying Township, Taiwan Recruiting -
National Cheng Kung University Hospital
Tainan, Taiwan Recruiting -
National Taiwan University Hospital
Taipei, Taiwan Recruiting -
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan Recruiting -
O Neal Comprehensive Cancer Center at UAB
Birmingham, Alabama, United States Completed -
University of Southern California
Los Angeles, California, United States Completed -
Georgetown University Hospital
Washington D.C., District of Columbia, United States Completed -
H Lee Moffitt Cancer Center
Tampa, Florida, United States Completed -
University of Maryland School of Medicine
Baltimore, Maryland, United States Completed -
Start Midwest
Grand Rapids, Michigan, United States Completed
+3 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Amivantamab with intrathecal pemetrexed for leptomeningeal metastasis from EGFR-mutated lung adenocarcinoma
This study tests whether giving amivantamab with intrathecal pemetrexed is safe and may help treat leptomeningeal metastasis in adults with EGFR-mutant lung cancer.
-
Amivantamab with Lazertinib or Chemotherapy before surgery in EGFR-mutated NSCLC
This study tests whether giving amivantamab together with lazertinib or with carboplatin and pemetrexed before surgery can slow or stop tumor growth in people with resectable EGFR-mutated NSCLC.
-
Amivantamab with platinum chemotherapy for metastatic EGFR‑mutant non‑small cell lung cancer
This study will try giving amivantamab together with platinum chemotherapy to adults with metastatic NSCLC who have specific EGFR mutations to see how long their cancer stays controlled and how safe the treatment is.
-
Amivantamab plus single‑agent chemotherapy for advanced non‑small cell lung cancer with EGFR exon 20 insertion in people unable to receive platinum
This trial will test whether adding amivantamab to a single chemotherapy drug helps people with metastatic non‑small cell lung cancer that has an EGFR exon 20 insertion who cannot get platinum chemotherapy.
-
Amivantamab added to pembrolizumab and platinum chemotherapy versus pembrolizumab with platinum/5‑FU for recurrent/metastatic head and neck squamous cell carcinoma
This trial will see if adding amivantamab to pembrolizumab and platinum‑based chemotherapy helps adults with recurrent or metastatic head and neck squamous cell carcinoma who have not yet had systemic treatment in the metastatic setting.
-
Clinical outcomes of amivantamab-based treatment for advanced EGFR-mutated non-small cell lung cancer in everyday care.
This project will see how amivantamab-containing treatments work for people with advanced non-small cell lung cancer who have common EGFR mutations.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.