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Clinical Trial 21881

Cancer Type: Gastrointestinal Tumor
Study Type: Treatment
NCT#: NCT05379595

Phase: Phase I/II
Principal Investigator: Biachi de Castria, Tiago

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Study Title

A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and in Combination with Chemotherapy in Patients 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 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).


Primary Objective- To assess the anti-tumor activity of amivantamab as a monotherapy in participants with mCRC Secondary Objective- To characterize the safety of amivantamab as a monotherapy in participants with mCRC



Chemotherapy (NOS); Immunotherapy


Amivantamab (); FOLFIRI (); FOLFOX6 (); JNJ-61186372 (Amivantamab)

Inclusion Criteria

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
  • 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
  • Other criteria may apply

  • Exclusion Criteria

    Exclusion Criteria:

  • 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.
  • Other criteria apply

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.