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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Janssen Research & Development, LLC • ClinicalTrials.gov ID: NCT05379595

Registry updated: 2026-09-25
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Description

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).

Interventions

  • Amivantamab IV (Biological)
    Amivantamab will be administered as intravenous infusion.
  • Fluorouracil (Biological)
    Fluorouracil will be administered as intravenous infusion.
  • Leucovorin (Biological)
    Leucovorin will be administered as intravenous infusion.
  • Oxaliplatin (Biological)
    Oxaliplatin will be administered as intravenous infusion.
  • Irinotecan (Biological)
    Irinotecan will be administered as intravenous infusion.
  • Amivantamab (Biological)
    Amivantamab will be administered.

Eligibility criteria

Inclusion Criteria: * Participant must have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum * Participant must have tumor previously characterized as having wild-type Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), v-raf murine sarcoma viral oncogene homolog B (BRAF), and without evidence of Erb-b2 receptor tyrosine kinase 2/human epidermal growth factor receptor 2 (ERBB2/HER2) amplification. Additional cohort-specific requirements: * Phase (Ph) 2 (Cohorts A, B, and C) Amivantamab monotherapy: Participant must have received at least 2 but not more than 3 prior lines of systemic therapy in the metastatic setting. Participant must have been diagnosed with left-sided colorectal cancer (CRC) (Cohort A and B) and right-sided (Cohort C)and have received or been intolerant to standard of care (SoC) fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and an anti-vascular endothelial growth factor (VEGF) treatment. Participant must be anti-EGFR treatment naive in Cohort A, an anti-epidermal growth factor receptor (EGFR) treatment Cohort B, with or without an anti-EGFR treatment in Cohort C * Ph 1b Dose Confirmation Cohorts (Ph1b-D and Ph1b-E), Ph2 (Cohorts D and E) Amivantamab+mFOLFOX6/FOLFIRI: Participant must been diagnosed with CRC and have received no more than 1 prior line of systemic therapy in the metastatic setting. Cohort Ph1b-D/Cohort D: Participant must be anti-EGFR treatment naïve, have not received oxaliplatin-based chemotherapy in the metastatic setting, and be eligible for treatment with mFOLFOX6 according to local regulatory approvals and SoC guidelines. Cohort Ph1b-E/Cohort E: Participant must be anti-EGFR treatment naïve, have not received irinotecan-based chemotherapy in the metastatic setting, and be eligible for treatment with FOLFIRI according to local regulatory approvals and SoC guidelines * Ph2 Cohorts F Amivantamab subcutaneous (SC) + mFOLFOX6: Participants must be treatment-naive for right-sided unresectable or metastatic CRC and be eligible for treatment with mFOLFOX6 according to local regulatory approvals and SoC guidelines * For Phase 1 dose confirmation cohorts (Cohorts Ph1b-D and Ph1b-E): Participant must have evaluable disease. For Phase 2: 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. Biopsies are required if clinically feasible for participants in Ph1b-D, Ph1b-E, and Cohort F. For Cohort F, archival tissue is required if a fresh biopsy is not feasible * 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 Exclusion Criteria: * Cohorts A, B, C, Ph1b-D, D, Ph1b-E, and E: 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; Cohort F: Participant with identified mutation in KRAS, NRAS, BRAF V600, or PTEN, identified fusions in ALK, ROS-1, RET, and NTRK 1, ERBB2/HER2 amplification, or identified to have MSI-H status by central 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

Conditions

Advanced or Metastatic Colorectal Cancer

Locations

  • O Neal Comprehensive Cancer Center at UAB — Birmingham, Alabama, United States
  • University of Southern California — Los Angeles, California, United States
  • University of California, Los Angeles UCLA — Los Angeles, California, United States
  • Georgetown University Hospital — Washington D.C., District of Columbia, United States
  • H Lee Moffitt Cancer Center — Tampa, Florida, United States
  • University of Maryland School of Medicine — Baltimore, Maryland, United States
  • University of Michigan Health System — Ann Arbor, Michigan, United States
  • Start Midwest — Grand Rapids, Michigan, United States
  • Hattiesburg Clinic — Hattiesburg, Mississippi, United States
  • NYU Langone Long Island Clinical Research Associates — New York, New York, United States
  • Herbert Irving Comprehensive Cancer Center Columbia University Medical Center — New York, New York, United States
  • Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
  • Vanderbilt Ingram Cancer Center — Nashville, Tennessee, United States
  • MD Anderson Cancer Center — Houston, Texas, United States
  • Institut Jules Bordet — Anderlecht, Belgium
  • Cliniques Universitaires Saint Luc — Brussels, Belgium
  • UZ Antwerpen — Edegem, Belgium
  • Universitair Ziekenhuis Gasthuisberg — Leuven, Belgium
  • BC Cancer Agency - Vancouver BC — Vancouver, British Columbia, Canada
  • The Ottawa Hospital Cancer Centre — Ottawa, Ontario, Canada
  • Princess Margaret Cancer Centre University Health Network — Toronto, Ontario, Canada
  • The Second Hospital To Dalian Medical University — Dalian, China
  • Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital — Guangzhou, China
  • The Second Affiliated Hospital of Zhejiang University College of Medicine — Hangzhou, China
  • Hubei province tumor hospital — Wuhan, China
  • Asklepios Klinik Altona — Hamburg, Germany
  • Ludwig-Maximilians-Universitaet Muenchen — Munich, Germany
  • Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy
  • A O Ospedale Niguarda Ca Granda — Milan, Italy
  • Azienda Ospedaliero Universitaria Pisana — Pisa, Italy
  • University Malaya Medical Centre — Kuala Lumpur, Malaysia
  • Hospital Umum Sarawak — Kuching, Malaysia
  • Beacon Hospital Sdn Bhd — Petaling Jaya, Malaysia
  • Ad Vance Medical Research — Ponce, Puerto Rico
  • Pan American Center for Oncology Trials LLC — Rio Piedras, Puerto Rico
  • Seoul National University Hospital — Seoul, South Korea
  • Severance Hospital Yonsei University Health System — Seoul, South Korea
  • Asan Medical Center — Seoul, South Korea
  • Samsung Medical Center — Seoul, South Korea
  • The Catholic University of Korea Seoul St Mary s Hospital — Seoul, South Korea
  • Hosp Univ Vall D Hebron — Barcelona, Spain
  • Hosp. Gral. Univ. Gregorio Maranon — Madrid, Spain
  • Hosp. Univ. Ramon Y Cajal — Madrid, Spain
  • Hosp Univ Fund Jimenez Diaz — Madrid, Spain
  • Hosp Univ Hm Sanchinarro — Madrid, Spain
  • Hosp. Univ. Marques de Valdecilla — Santander, Spain
  • Hosp. Clinico Univ. de Valencia — Valencia, Spain
  • Changhua Christian Hospital — Changhua, Taiwan
  • Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan
  • Chi Mei Medical Center Liu Ying — Liou Ying Township, Taiwan
  • National Cheng Kung University Hospital — Tainan, Taiwan
  • National Taiwan University Hospital — Taipei, Taiwan
  • Linkou Chang Gung Memorial Hospital — Taoyuan, Taiwan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record