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.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Advanced Or Metastatic Colorectal Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion 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.

You may not be eligible for this study if the following are true:

  • Participant with known HER-2 amplification based on the local testing results. Participant with identified mutation in KRAS, NRAS, BRAF or EGFR ectodomain, or ERBB2/HER2 amplification by central circulating tumor deoxyribonucleic acid (ctDNA) testing at screening. Participant with symptomatic brain metastasis. History or known presence of leptomeningeal disease.


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