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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: Recruiting Phase 1 study of Advanced or Metastatic Colorectal Cancer, sponsored by Janssen Research & Development.
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (275% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
ORR is defined as the percentage of participants who achieve either a partial response (PR) or complete response (CR), as defined by investigator assessment using Response Criteria in Solid Tumors (RECIST) version 1.1.
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 |
What NCT05379595 shows while recruiting
NCT05379595 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (275% higher).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05379595's enrollment target sits among peer trials
225 224th of 2000 higher than 1,774 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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