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
-

Cetuximab in Head and Neck Cancer Patients

Phase 2
Completed
Conditions
Interventions
First Posted Date
2018-12-07
Last Posted Date
2023-05-24
Lead Sponsor
University of Wisconsin, Madison
Target Recruit Count
15
Registration Number
NCT03769311
Locations
🇺🇸

University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States

Afatinib and Cetuximab in Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Positive Non-small-cell Lung Cancer

First Posted Date
2018-11-01
Last Posted Date
2023-10-18
Lead Sponsor
The Netherlands Cancer Institute
Target Recruit Count
37
Registration Number
NCT03727724
Locations
🇳🇱

Antoni van Leeuwenhoek, Amsterdam, North-Holland, Netherlands

🇳🇱

VU Medical Center, Amsterdam, Netherlands

🇳🇱

Maastricht UMC+, Maastricht, Netherlands

and more 1 locations

Cetuximab and Vemurafenib Plus FOLFIRI for BRAF V600E Mutated Advanced Colorectal Cancer (IMPROVEMENT)

First Posted Date
2018-11-01
Last Posted Date
2021-08-19
Lead Sponsor
Shanghai Changzheng Hospital
Target Recruit Count
30
Registration Number
NCT03727763
Locations
🇨🇳

Shanghai Changzheng Hospital, Shanghai, Shanghai, China

Study of Avelumab and Cetuximab Plus Gemcitabine and Cisplatin in Participants With NSCLC

First Posted Date
2018-10-24
Last Posted Date
2022-06-06
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Target Recruit Count
43
Registration Number
NCT03717155
Locations
🇭🇺

Petz Aladar Megyei Oktato Korhaz - Pulmonologiai Osztaly, Gyor, Hungary

🇭🇺

Tudogyogyintezet Torokbalint - Onkopulmonologiai es Jarobeteg centrum, Torokbalint, Hungary

🇪🇸

Hospital Universitari Vall d'Hebron - Dept of Oncology, Barcelona, Spain

and more 17 locations

GSK3359609 Plus Tremelimumab for the Treatment of Advanced Solid Tumors

First Posted Date
2018-10-03
Last Posted Date
2024-08-28
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
26
Registration Number
NCT03693612
Locations
🇨🇦

GSK Investigational Site, Toronto, Ontario, Canada

Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

First Posted Date
2018-10-02
Last Posted Date
2023-12-08
Lead Sponsor
Trisha Wise-Draper
Target Recruit Count
36
Registration Number
NCT03691714
Locations
🇺🇸

UC Health, Cincinnati, Ohio, United States

Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer

First Posted Date
2018-10-02
Last Posted Date
2024-02-02
Lead Sponsor
Pierre Fabre Medicament
Target Recruit Count
95
Registration Number
NCT03693170
Locations
🇫🇷

AP-HM CHU Timone, Marseille, France

🇫🇷

ICO- Site René Gauducheau, Saint-Herblain, France

🇫🇷

Hôpital Europeen Georges Pompidou, Paris, France

and more 37 locations

Cabozantinib in Combination With Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer

First Posted Date
2018-09-12
Last Posted Date
2024-07-23
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
20
Registration Number
NCT03667482
Locations
🇺🇸

Baptist Alliance MCI, Miami, Florida, United States

🇺🇸

Lehigh Valley Health Network, Allentown, Pennsylvania, United States

🇺🇸

Memorial Sloan Kettering Nassau, Uniondale, New York, United States

and more 6 locations

Immunotherapy +/- EGFR Inhibitor In Advanced/Metastatic cSCC: Tackling Primary And Secondary Resistance

First Posted Date
2018-09-11
Last Posted Date
2018-09-11
Lead Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Target Recruit Count
43
Registration Number
NCT03666325
Locations
🇮🇹

ASST Spedali Civili di Brescia, Brescia, BS, Italy

🇮🇹

Istituto IRCCS AOU S. Martino, Genova, Italy

🇮🇹

Istituto Europeo di Oncologia, Milan, MI, Italy

and more 4 locations

QUILT-3.091 NANT Chordoma Vaccine vs Radiation in Subjects With Unresectable Chordoma.

First Posted Date
2018-08-27
Last Posted Date
2021-03-19
Lead Sponsor
ImmunityBio, Inc.
Registration Number
NCT03647423
Locations
🇺🇸

Chan Soon-Shiong Institute for Medicine, El Segundo, California, United States

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