A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer
Public ClinicalTrials.gov record NCT05379595. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT05379595
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 225 participants
Conditions and interventions
Conditions
Interventions
- Amivantamab IV Biological
- Fluorouracil Biological
- Leucovorin Biological
- Oxaliplatin Biological
- Irinotecan Biological
- Amivantamab Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 28, 2022
- Primary completion
- Apr 26, 2027
- Completion
- Oct 30, 2030
- Last update posted
- Aug 27, 2026
2022 – 2030
United States locations
- U.S. sites
- 14
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| O Neal Comprehensive Cancer Center at UAB | Birmingham | Alabama | 35233 | Completed |
| University of Southern California | Los Angeles | California | 90033 | Completed |
| University of California, Los Angeles UCLA | Los Angeles | California | 90404 | Recruiting |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | Completed |
| H Lee Moffitt Cancer Center | Tampa | Florida | 33612 | Completed |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | Completed |
| University of Michigan Health System | Ann Arbor | Michigan | 48103 | Recruiting |
| Start Midwest | Grand Rapids | Michigan | 49546 | Completed |
| Hattiesburg Clinic | Hattiesburg | Mississippi | 39401 | Recruiting |
| NYU Langone Long Island Clinical Research Associates | New York | New York | 10016 | Recruiting |
| Herbert Irving Comprehensive Cancer Center Columbia University Medical Center | New York | New York | 10032 | Recruiting |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | Completed |
| Vanderbilt Ingram Cancer Center | Nashville | Tennessee | 37232 | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 39 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05379595, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 27, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05379595 live on ClinicalTrials.gov.