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cetuximab, capecitabine
cetuximab, capecitabine is a EGFR inhibitor, thymidylate synthase inhibitor Small molecule drug developed by Institute of Oncology Ljubljana. It is currently in Phase 3 development for Metastatic colorectal cancer, Head and neck cancer. Also known as: Erbitux, Xeloda.
Cetuximab is a monoclonal antibody that targets the epidermal growth factor receptor (EGFR), while capecitabine is a prodrug that is converted into 5-fluorouracil, a thymidylate synthase inhibitor.
Cetuximab is a monoclonal antibody that targets the epidermal growth factor receptor (EGFR), while capecitabine is a prodrug that is converted into 5-fluorouracil, a thymidylate synthase inhibitor. Used for Metastatic colorectal cancer, Head and neck cancer.
At a glance
| Generic name | cetuximab, capecitabine |
|---|---|
| Also known as | Erbitux, Xeloda |
| Sponsor | Institute of Oncology Ljubljana |
| Drug class | EGFR inhibitor, thymidylate synthase inhibitor |
| Target | EGFR, thymidylate synthase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Cetuximab binds to the EGFR on the surface of cancer cells, preventing the receptor from interacting with its ligands and thereby inhibiting cell proliferation. Capecitabine is converted into 5-fluorouracil, which is then incorporated into DNA, causing DNA damage and inhibiting thymidylate synthase, a key enzyme in DNA synthesis.
Approved indications
- Metastatic colorectal cancer
- Head and neck cancer
Common side effects
- Skin rash
- Diarrhea
- Fatigue
- Hand-foot syndrome
- Neutropenia
Key clinical trials
- Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors (PHASE1, PHASE2)
- A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer (PHASE1)
- Anti-EGFR Agents in Patients With Right-sided Advanced Colorectal Cancer With Wild-type RAS and AREG/EREG High Status (PHASE4)
- Holmium-166 TARE in Liver Limited Unresectable Colorectal Cancer Patients (PHASE2)
- Clinical Study of Second-line Treatment in Advanced Colorectal Cancer With Chemotherapy With Bevacizumab or Cetuximab (PHASE2)
- Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009) (PHASE2)
- Efficacy and Safety of Triweekly Cetuximab in Combination With Capecitabine as First-line Maintenance Treatment for KRAS/BRAF Wild-type Metastatic Colorectal Cancer (PHASE1, PHASE2)
- A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- cetuximab, capecitabine CI brief — competitive landscape report
- cetuximab, capecitabine updates RSS · CI watch RSS
- Institute of Oncology Ljubljana portfolio CI
Frequently asked questions about cetuximab, capecitabine
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Related
- Drug class: All EGFR inhibitor, thymidylate synthase inhibitor drugs
- Target: All drugs targeting EGFR, thymidylate synthase
- Manufacturer: Institute of Oncology Ljubljana — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic colorectal cancer
- Indication: Drugs for Head and neck cancer
- Also known as: Erbitux, Xeloda
- Compare: cetuximab, capecitabine vs similar drugs
- Pricing: cetuximab, capecitabine cost, discount & access