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A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer

NCT05379595 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2026-05-08

No results posted yet for this 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

  • Advanced or Metastatic Colorectal Cancer

Interventions

BIOLOGICAL

Amivantamab IV

Amivantamab will be administered as intravenous infusion.

BIOLOGICAL

Fluorouracil

Fluorouracil will be administered as intravenous infusion.

BIOLOGICAL

Leucovorin

Leucovorin will be administered as intravenous infusion.

BIOLOGICAL

Oxaliplatin

Oxaliplatin will be administered as intravenous infusion.

BIOLOGICAL

Irinotecan

Irinotecan will be administered as intravenous infusion.

BIOLOGICAL

Amivantamab

Amivantamab will be administered.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-29
Primary Completion
2027-04-27
Completion
2030-10-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • China
  • Germany
  • Italy
  • Malaysia
  • Puerto Rico
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05379595 on ClinicalTrials.gov