A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer
NCT ID: NCT05379595
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
225 participants
INTERVENTIONAL
2022-07-29
2031-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohorts A, B, and C: Amivantamab Monotherapy
Participants with left-sided colorectal cancer (CRC) in Cohort A (no prior anti-epidermal growth factor receptor \[EGFR\] therapy) and in Cohort B (post anti-EGFR therapy), and right-sided CRC in Cohort C (with or without anti-EGFR therapy), will be administered intravenous (IV) infusion of amivantamab 1050 milligrams (mg) if body weight (BW) is less than (\<) 80 kilograms (kg) or 1400 mg if BW is greater than or equal to (\>=) 80 kg, as monotherapy on Days 1 and 15 of Cycle 2 (28-days cycle).
Amivantamab IV
Amivantamab will be administered as intravenous infusion.
Cohorts Ph1b-D and D: Amivantamab+5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX6)
Participants who are anti-EGFR treatment naïve, have not received oxaliplatin-based chemotherapy in the metastatic setting, will be administered IV infusion of amivantamab 1050 or 700 mg (dose level 0 \[DL0\]) if BW is \<80 kg, or 1400 or 1050 mg (dose de-escalation \[DL-1\]) if BW is \>= 80 kg, on Days -1, -2, 8 and 22 of Cycle 1 and along with mFOLFOX6 SOC chemotherapy on Days 1 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 (each cycle of 28 days) in Phase 1b dose confirmation Cohort (Cohort Ph1b-D). Participant in Phase 2 Cohort (Cohort D) will receive recommended Phase 2 combination dose (RP2CD) of amivantamab along with mFOLFOX6 SOC chemotherapy determined in Cohort Ph1b-D.
Amivantamab IV
Amivantamab will be administered as intravenous infusion.
Fluorouracil
Fluorouracil will be administered as intravenous infusion.
Leucovorin
Leucovorin will be administered as intravenous infusion.
Oxaliplatin
Oxaliplatin will be administered as intravenous infusion.
Cohorts Ph1b-E and E: Amivantamab+5-Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI)
Participants who are anti-EGFR treatment naïve, have not received irinotecan-based chemotherapy in the metastatic setting, will be administered IV infusion of Amivantamab along with FOLFIRI SOC chemotherapy on Days -1, -2, and 8 of Cycle 1 and Days 1 and 15 of Cycle 2 in Ph1b-E. For Cohort E, RP2CD determined in Ph1b-E will be administered.
Amivantamab IV
Amivantamab will be administered as intravenous infusion.
Fluorouracil
Fluorouracil will be administered as intravenous infusion.
Leucovorin
Leucovorin will be administered as intravenous infusion.
Irinotecan
Irinotecan will be administered as intravenous infusion.
Cohort F: Amivantamab + mFOLFOX6
Participant who are treatment-naïve for right-sided unresectable or metastatic CRC. Participants will receive Amivantamab along with mFOLFOX6 SoC chemotherapy.
Fluorouracil
Fluorouracil will be administered as intravenous infusion.
Leucovorin
Leucovorin will be administered as intravenous infusion.
Oxaliplatin
Oxaliplatin will be administered as intravenous infusion.
Amivantamab
Amivantamab will be administered.
Interventions
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Amivantamab IV
Amivantamab will be administered as intravenous infusion.
Fluorouracil
Fluorouracil will be administered as intravenous infusion.
Leucovorin
Leucovorin will be administered as intravenous infusion.
Oxaliplatin
Oxaliplatin will be administered as intravenous infusion.
Irinotecan
Irinotecan will be administered as intravenous infusion.
Amivantamab
Amivantamab will be administered.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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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 District, , Taiwan
Countries
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Central Contacts
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Other Identifiers
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61186372GIC2002
Identifier Type: OTHER
Identifier Source: secondary_id
2021-006629-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-506517-22-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109215
Identifier Type: -
Identifier Source: org_study_id