Cetuximab

Generic Name
Cetuximab
Brand Names
Erbitux
Drug Type
Biotech
Chemical Formula
-
CAS Number
205923-56-4
Unique Ingredient Identifier
PQX0D8J21J
Background

Cetuximab is a recombinant chimeric human/mouse IgG1 monoclonal antibody that competitively binds to epidermal growth factor receptor (EGFR) and competitively inhibits the binding of epidermal growth factor (EGF). EGFR is a member of the ErbB family of receptor tyrosine kinases found in both normal and tumour cells; it is responsible for regulating epithelial tissue development and homeostasis. EGFR has been implicated in various types of cancer, as it is often overexpressed in malignant cells and EGFR overexpression has been linked to more advanced disease and poor prognosis. EGFR is often mutated in certain types of cancer and serves as a driver of tumorigenesis. In vitro, cetuximab was shown to mediate anti-tumour effects in numerous cancer cell lines and human tumour xenografts.

Approved by the FDA in February 2004 under the brand name ERBITUX, cetuximab is used for the treatment of head and neck cancer and metastatic, KRAS wild-type colorectal cancer, and metastatic colorectal cancer with a BRAF V600E mutation. It has also been investigated in advanced colorectal cancer, EGFR-expressing non-small cell lung cancer (NSCLC), and unresectable squamous cell skin cancer. Cetuximab is administered via intravenous infusion and is used as monotherapy or in combination with other chemotherapies, including platinum agents, radiation therapy, leucovorin, fluorouracil, and irinotecan.

Indication

Cetuximab indicated for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. It is indicated for treating a recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil. It is indicated for recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy.

Cetuximab is also indicated for K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with FOLFIRI, a chemotherapy combination that includes leucovorin, fluorouracil, and irinotecan; in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy; or as monotherapy in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.

Additionally, cetuximab is also indicated for metastatic colorectal cancer that is BRAF V600E mutation-positive (as determined by an FDA-approved test) in combination with encorafenib but only after prior therapy.

Cetuximab is not indicated for the treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown.

Associated Conditions
Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN), Metastatic Colorectal Cancer (CRC), Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC), Regionally Advanced Squamous Cell Carcinoma of the Head and Neck, Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Associated Therapies
-

Avelumab Plus Cetuximab in Pre-treated RAS Wild Type Metastatic Colorectal Cancer

First Posted Date
2020-09-23
Last Posted Date
2022-05-05
Lead Sponsor
University of Campania "Luigi Vanvitelli"
Target Recruit Count
77
Registration Number
NCT04561336
Locations
🇮🇹

Università della Campania Luigi Vanvitelli, Napoli, Italy

MoLiMoR - A Study With FOLFIRI-based First-line Therapy With or Without Intermittent Cetuximab

First Posted Date
2020-09-18
Last Posted Date
2024-04-10
Lead Sponsor
TheraOp
Target Recruit Count
144
Registration Number
NCT04554836
Locations
🇩🇪

Onkologisches Zentrum (Dachau II), Dachau, Germany

🇩🇪

Kliniken-Essen-Mitte Evang. Huyssens-Stiftung, Essen, Germany

🇩🇪

Universitätsklinikum Knappschaftskrankenhaus, Bochum, Germany

and more 1 locations

AVELUMAB and CETUXIMAB and mFOLFOXIRI as Initial Therapy for Unresectable Metastatic Colorectal Cancer Patients

First Posted Date
2020-08-14
Last Posted Date
2023-09-13
Lead Sponsor
Gruppo Oncologico del Nord-Ovest
Target Recruit Count
58
Registration Number
NCT04513951
Locations
🇮🇹

U.O. Oncologia Medica 2 Universitaria - Azienda Ospedaliero-Universitaria Pisana Dipartimento di Ricerca Traslazionale e Nuove Tecnologie - University of Pisa, Pisa, Italy

Cetuximab Re-challenge for Colorectal Cancer Liver Metastasis

First Posted Date
2020-08-12
Last Posted Date
2020-08-12
Lead Sponsor
Fudan University
Target Recruit Count
50
Registration Number
NCT04509635

MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01)

Phase 1
Completed
Conditions
Interventions
First Posted Date
2020-08-03
Last Posted Date
2024-05-16
Lead Sponsor
Menarini Group
Target Recruit Count
29
Registration Number
NCT04495621
Locations
🇺🇸

The Oncology Institute of Hope and Innovation, Anaheim, California, United States

🇺🇸

MultiCare Health System Institute for Research and Innovation, Tacoma, Washington, United States

🇫🇷

ICO - Site Paul Papin, Angers, France

and more 24 locations

TTX-080 HLA-G Antagonist in Subjects with Advanced Cancers

First Posted Date
2020-07-24
Last Posted Date
2024-12-05
Lead Sponsor
Tizona Therapeutics, Inc
Target Recruit Count
240
Registration Number
NCT04485013
Locations
🇺🇸

Arizona Oncology Associates, Tucson, Arizona, United States

🇺🇸

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

🇺🇸

Hoag Memorial Hospital, Newport Beach, California, United States

and more 35 locations

Efficacy and Safety Study of Combination of CPGJ602 and Chemotherapy, in First Line, With Wild KRAS/NRAS/BRAF in Metastatic Colorectal Cancer

First Posted Date
2020-07-10
Last Posted Date
2021-08-23
Lead Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Target Recruit Count
75
Registration Number
NCT04466254
Locations
🇨🇳

Chinese PLA General Hospital, Beijing, Beijing, China

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

First Posted Date
2020-06-29
Last Posted Date
2024-12-09
Lead Sponsor
Genentech, Inc.
Target Recruit Count
498
Registration Number
NCT04449874
Locations
🇺🇸

UPMC - Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Univ of Calif, San Francisco; Breast Cancer Center, San Francisco, California, United States

and more 72 locations
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