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NCT05379595 · ClinicalTrials.gov registry record · Phase 1
A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer
A Phase 1 study of Advanced or Metastatic Colorectal Cancer, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 225
- Enrollment target
- 20
- Study locations
NCT05379595 is a Phase 1 study of Advanced or Metastatic Colorectal Cancer that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 225 participants. The trial reports 20 study locations across 14 states.
The verdict
NCT05379595, a Phase 1 study of Advanced or Metastatic Colorectal Cancer, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 225 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Conditions Studied
Interventions
- BIOLOGICAL Amivantamab IV
- BIOLOGICAL Fluorouracil
- BIOLOGICAL Leucovorin
- BIOLOGICAL Oxaliplatin
- BIOLOGICAL Irinotecan
Study Locations (20)
Other
- Institut Jules Bordet - Anderlecht
- Cliniques Universitaires Saint Luc - Brussels
- UZ Antwerpen - Edegem
- Universitair Ziekenhuis Gasthuisberg - Leuven
California
- University of Southern California - Los Angeles
- University of California, Los Angeles UCLA - Los Angeles
Michigan
- University of Michigan Health System - Ann Arbor
- Start Midwest - Grand Rapids
New York
- NYU Langone Long Island Clinical Research Associates - New York
- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center - New York
Alabama
- O Neal Comprehensive Cancer Center at UAB - Birmingham
District of Columbia
- Georgetown University Hospital - Washington D.C.
Florida
- H Lee Moffitt Cancer Center - Tampa
Maryland
- University of Maryland School of Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2022-07-29 |
| Est. Completion | 2030-10-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05379595
The ClinicalTrials.gov registry entry for NCT05379595 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Advanced or Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Amivantamab IV is the first listed.
NCT05379595 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Other, California, Michigan.
Frequently Asked Questions
What is clinical trial NCT05379595 about?
NCT05379595 is a clinical study titled "A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer". 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 st...
What is the current status of trial NCT05379595?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 225 participants. The study started on 2022-07-29. Estimated completion is 2030-10-31.
What conditions does trial NCT05379595 study?
This clinical trial studies the following conditions: Advanced or Metastatic Colorectal Cancer.
What interventions are being tested in trial NCT05379595?
The interventions under investigation include: Amivantamab IV (BIOLOGICAL), Fluorouracil (BIOLOGICAL), Leucovorin (BIOLOGICAL), Oxaliplatin (BIOLOGICAL), Irinotecan (BIOLOGICAL).
Who is sponsoring clinical trial NCT05379595?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05379595 being conducted?
This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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