cetuximab
Trade name: erbitux
mAbapprovedOrphan Drug FDA
Approved
Feb 12, 2004
Cetuximab, sold under the brand name Erbitux, is an epidermal growth factor receptor (EGFR) inhibitor medication used for the treatment of metastatic colorectal cancer and head and neck cancer. Cetuximab is a chimeric (mouse/human) monoclonal antibody given by intravenous infusion. — Wikipedia
Clinical trial activity
934 trials · 572 clinical orgs · 2 marketing orgs
Phase 1
282
Phase 2
727
Phase 3
120
Phase 4
9
Earliest trial started Apr 1, 1999 (NCT00004227)
Timeline
Indications
Studied for
- Adenocarcinoma · Phase 3
- Adenocarcinoma of Lung · Phase 2
- Aged · Phase 3
- Antibody-Dependent Cell Cytotoxicity · Phase 2
- Antineoplastic Agents · Phase 3
- Anus Neoplasms · Phase 2
- Appendiceal Neoplasms · Phase 1/Phase 2
- Appendix · Phase 1
- Astrocytoma · Phase 2
- Barrett Esophagus · Phase 2
- Basal Cell Carcinoma · Phase 1/Phase 2
- Bile Duct Neoplasms · Phase 2
- Biliary Tract Neoplasms · Phase 2
- Brain Neoplasms · Phase 2
- Breast Neoplasms · Phase 2
- Capecitabine · Phase 3
- Carcinoma · Phase 2
- Carcinoma, Adenoid Cystic · Phase 1/Phase 2
- Carcinoma, Hepatocellular · Phase 2
- Carcinoma, Mucoepidermoid · Phase 1/Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 3
- Carcinoma, Pancreatic Ductal · Phase 1
- Carcinoma, Renal Cell · Phase 1/Phase 2
- Carcinoma, Squamous Cell · Phase 3
- Carcinoma, Transitional Cell · Phase 1/Phase 2
- Carcinoma, Verrucous · Phase 2
- Castleman Disease · Phase 1
- Cetuximab · Phase 3
- Cholangiocarcinoma · Phase 2
- Chordoma · Phase 2
- Colonic Neoplasms · Phase 4
- Complex Regional Pain Syndromes · Phase 2
- Diffuse Intrinsic Pontine Glioma · Phase 1/Phase 2
- Digestive System Neoplasms · Phase 1
- Disease Progression · Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 3
- Drugs, Investigational · Phase 2
- Endometrial Neoplasms · Phase 2
- Epidermal Growth Factor · Phase 2
- ErbB Receptors · Phase 2
- Erdheim-Chester Disease · Phase 1
- Esophageal Neoplasms · Phase 3
- Esophageal Squamous Cell Carcinoma · Phase 2
- Fallopian Tube Neoplasms · Phase 2
- Gallbladder Neoplasms · Phase 2
- Gastrointestinal Neoplasms · Phase 1/Phase 2
- Gastrointestinal Stromal Tumors · Phase 1/Phase 2
- General Surgery · Phase 2
- Genes, erbB-2 · Phase 1/Phase 2
- Genes, ras · Phase 1
- Glioblastoma · Phase 2
- Glioma · Phase 2
- Graft vs Host Disease · Phase 2
- Granuloma · Phase 1/Phase 2
- Hamartoma · Phase 2
- Head and Neck Neoplasms · Phase 4
- Healthy Volunteers · Phase 1
- Hypopharyngeal Neoplasms · Phase 3
- Immunotherapy · Phase 2
- Intestinal Neoplasms · Phase 2
- Kidney Neoplasms · Phase 1
- Laryngeal Neoplasms · Phase 3
- Lip · Phase 2
- Liver Diseases · Phase 2
- Liver Neoplasms · Phase 4
- Lung Diseases · Phase 1
- Lung Neoplasms · Phase 3
- Lymphangioleiomyomatosis · Phase 1
- Lymphoma · Phase 1
- Lymphoma, Non-Hodgkin · Phase 2
- Margins of Excision · Phase 1/Phase 2
- Melanoma · Phase 1
- Molecular Sequence Data · Phase 3
- Mouth Neoplasms · Phase 3
- Multiple Myeloma · Phase 2
- Mutation · Phase 3
- Nasopharyngeal Carcinoma · Phase 3
- Nasopharyngeal Neoplasms · Phase 2
- Neoadjuvant Therapy · Phase 2
- Neoplasm Metastasis · Phase 4
- Neoplasm Recurrence, Local · Phase 1
- Neoplasm, Residual · Phase 1
- Neoplasms, Mesothelial · Phase 1
- Neoplasms, Second Primary · Phase 2
- Neoplasms, Squamous Cell · Phase 2
- Neoplasms, Unknown Primary · Phase 2
- Neoplastic Cells, Circulating · Phase 2
- Neuralgia · Phase 2
- Neuroblastoma · Phase 1/Phase 2
- Neurofibromatosis 2 · Phase 1
- Nose Neoplasms · Phase 2
- Oligodendroglioma · Phase 1/Phase 2
- Oropharyngeal Neoplasms · Phase 3
- Ovarian Neoplasms · Phase 2
- Pancreatic Neoplasms · Phase 3
- Papilloma, Inverted · Phase 1/Phase 2
- Papillomaviridae · Phase 2
- Paranasal Sinus Neoplasms · Phase 2
- Penile Neoplasms · Phase 1
- Peritoneal Neoplasms · Phase 2
- Pharmacological and Toxicological Phenomena · Phase 1
- Pharyngeal Neoplasms · Phase 2
- Pleural Effusion, Malignant · Phase 2
- Precancerous Conditions · Phase 3
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 1
- Prostatic Neoplasms · Phase 2
- Prostatic Neoplasms, Castration-Resistant · Phase 1
- Proto-Oncogene Proteins B-raf · Phase 2
- Quality of Life · Phase 3
- ras GTPase-Activating Proteins · Phase 1/Phase 2
- ras Proteins · Phase 2
- Rectal Neoplasms · Phase 2
- Rhabdomyosarcoma · Phase 1
- Safety · Phase 2
- Salivary Gland Neoplasms · Phase 2
- Sarcoma · Phase 2
- Skin Diseases · Phase 2
- Skin Neoplasms · Phase 2
- Soft Tissue Neoplasms · Phase 1
- Squamous Cell Carcinoma of Head and Neck · Phase 3
- Stomach Neoplasms · Phase 3
- Thoracic Surgery, Video-Assisted · Phase 2
- Thymoma · Phase 2
- Thyroid Neoplasms · Phase 1
- Tongue Neoplasms · Phase 2
- Triple Negative Breast Neoplasms · Phase 1/Phase 2
- Urinary Bladder Neoplasms · Phase 2
- Urologic Neoplasms · Phase 2
- Uterine Cervical Neoplasms · Phase 2
Mechanism of action
EGFR inhibitor
Approval history
- approvedAcceleratedFeb 12, 2004
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- WikipediaCetuximab ↗
- NCATSPQX0D8J21J ↗
- ChEMBLCHEMBL6068223 ↗
- ChEMBLCHEMBL1201577 ↗
Also known as
- c225
- c225
- c-225
- centuximab
- cetuximab
- cetuximab
- cetuximab
- cetuximab
- cetuximab
- cetuximab
- cetuximab
- cetuximab
- cetuximab
- cetuximab
- cetuximab
- cétuximab
- cétuximab
- cetuximab (genetical recombination)
- cetuximabum
- cetxuimab
- erbitux
- erbitux
- erbitux
- erbitux
- imc-225
- imc-c225
- imc-c225
- imc-c225
- immunoglobulin g 1 (human-mouse monoclonal c 225 gamma 1 - chain anti-human epidermal growt factor receptor), disulfide wit human-mouse monoclonal c 225 kappa - chain, dimer
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07286149 | Phase 1/Phase 2 (Phase 2) | Feb 9, 2026 | Daiichi Sankyo, Merck |
| NCT07217028 | Phase 1 | Jan 31, 2026 | Vanderbilt University |
| NCT07302841 | Phase 4 | Jan 20, 2026 | Tianjin Medical University |
| NCT07252739 | Phase 2 | Jan 14, 2026 | Merck |
| NCT07004413 | Phase 3 | Jan 1, 2026 | Humboldt University |
| NCT07294261 | Phase 2 | Dec 23, 2025 | Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd, Sun Yat-Sen University |
| NCT07042295 | Phase 2 | Dec 22, 2025 | National Cancer Institute (NCI), SWOG Cancer Research Network |
| NCT07247110 | Phase 1 | Dec 1, 2025 | Merck |
| NCT07223047 | Phase 1/Phase 2 (Phase 2) | Nov 26, 2025 | Bristol-Myers Squibb |
| NCT07209111 | Phase 2 | Nov 24, 2025 | Merck |
| NCT07300150 | Phase 1 | Nov 21, 2025 | PAQ Therapeutics, Inc. |
| NCT07094893 | Phase 4 | Nov 15, 2025 | Gruppo Oncologico del Nord-Ovest, Merck Serono |
| NCT07216105 | Phase 1 | Nov 4, 2025 | Fate Therapeutics |
| NCT06943664 | Phase 2 | Nov 1, 2025 | Rakuten, State University of New York, Buffalo |
| NCT07257653 | Phase 2 | Oct 21, 2025 | Zhejiang University |
| NCT07204340 | Phase 1 | Oct 9, 2025 | Treeline Biosciences, Inc. |
| NCT07198841 | Phase 2 | Sep 30, 2025 | Guangdong Association of Clinical Trials, Innovent Biologics (Suzhou) Co. Ltd. |
| NCT06998069 | Phase 3 | Sep 30, 2025 | Brown University, Rhode Island Hospital |
| NCT06912087 | Phase 1 | Sep 29, 2025 | Exelixis, University of Chicago |
| NCT06865664 | Phase 1 | Sep 22, 2025 | National Cancer Institute (NCI) |
Showing 20 of 934 trials
Page 1 / 47
Organizations
Research & Development (572)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Government | 130 | 47 | 4 | 1999 |
| Bristol-Myers Squibb | For profit | 88 | 14 | 4 | 2003 |
| Merck | For profit | 48 | 15 | 3 | 2004 |
| Merck KGaA | For profit | 44 | 22 | 3 | 2004 |
| Eli Lilly | For profit | 43 | 28 | 3 | 2003 |
| Imclone | For profit | 42 | 16 | 3 | 1999 |
| University of Texas at Houston | Academic/Hospital | 40 | 29 | 3 | 2004 |
| Fudan University | Academic/Hospital | 32 | 23 | 5 | 2006 |
| Pfizer | For profit | 25 | 10 | 5 | 2004 |
| Sun Yat-Sen University | Academic/Hospital | 21 | 21 | 3 | 2008 |
| Harvard University | Academic/Hospital | 20 | 14 | 3 | 2004 |
| Merck Serono | For profit | 19 | 3 | 4 | 2007 |
| Roche | For profit | 18 | 9 | 3 | 2004 |
| Sanofi | For profit | 18 | 2 | 4 | 2004 |
| University of Pittsburgh | Academic/Hospital | 18 | 14 | 2 | 2005 |
| Cornell University | Academic/Hospital | 17 | 12 | 4 | 1999 |
| Huazhong University of Science and Technology | Academic/Hospital | 14 | 6 | 3 | 2009 |
| Jiao Tong University | Academic/Hospital | 14 | 12 | 2 | 2009 |
| Southwest Oncology Group | Academic/Hospital | 14 | 10 | 3 | 2004 |
| Eastern Cooperative Oncology Group | Academic/Hospital | 13 | 8 | 2 | 1999 |
572 organizations
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