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

Description

The purpose of this study is to assess the anti-tumor activity of amivantamab as a monotherapy (Cohorts A, B, and C), to characterize the safety of amivantamab when added to standard-of care (SoC) chemotherapy in participants with metastatic colorectal cancer (mCRC) (Ph2 cohorts), and to assess the recommended phase 2 combination dose (RP2CD) of amivantamab when added to SoC chemotherapy (Ph1b cohorts).

Conditions

Advanced or Metastatic Colorectal Cancer

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Study Overview

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Study Details

Study overview

The purpose of this study is to assess the anti-tumor activity of amivantamab as a monotherapy (Cohorts A, B, and C), to characterize the safety of amivantamab when added to standard-of care (SoC) chemotherapy in participants with metastatic colorectal cancer (mCRC) (Ph2 cohorts), and to assess the recommended phase 2 combination dose (RP2CD) of amivantamab when added to SoC chemotherapy (Ph1b cohorts).

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

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

Condition
Advanced or Metastatic Colorectal Cancer
Intervention / Treatment

-

Contacts and Locations

Birmingham

O Neal Comprehensive Cancer Center at UAB, Birmingham, Alabama, United States, 35233

Los Angeles

University of Southern California, Los Angeles, California, United States, 90033

Los Angeles

University of California, Los Angeles UCLA, Los Angeles, California, United States, 90404

Washington

Georgetown University Hospital, Washington, District of Columbia, United States, 20007

Tampa

H Lee Moffitt Cancer Center, Tampa, Florida, United States, 33612

Baltimore

University of Maryland School of Medicine, Baltimore, Maryland, United States, 21201

Ann Arbor

University of Michigan Health System, Ann Arbor, Michigan, United States, 48103

Grand Rapids

Start Midwest, Grand Rapids, Michigan, United States, 49546

Hattiesburg

Hattiesburg Clinic, Hattiesburg, Mississippi, United States, 39401

New York

NYU Langone Long Island Clinical Research Associates, New York, New York, United States, 10016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participant must have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum
  • * For Phase 1 dose confirmation cohorts (Cohorts Ph1b-D and Ph1b-E): Participant must have evaluable disease. For Phase 2 dose expansion cohorts (Cohorts D and E): 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
  • * 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
  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

2027-04-27