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Also known as HuMax-EGFr
zalutumumab · 4 trials · 3 indications
| Name | Type | Description |
|---|---|---|
| Zalutumumab | DRUG | Individual dose titration weekly i.v doses |
| Control | OTHER | Best Supportive Care |
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Zalutumumab is an investigational monoclonal antibody developed for head and neck cancer, including squamous cell carcinoma of the head and neck and head and neck neoplasms. It has been studied in patients with non-curable head and neck cancer. It is not an approved therapy and remains in clinical development.
Zalutumumab targets EGFR, the epidermal growth factor receptor. It is an antagonist monoclonal antibody, meaning it binds EGFR and blocks receptor signaling rather than activating it. EGFR is a validated oncology target frequently overexpressed in squamous cell carcinoma of the head and neck.
Zalutumumab is developed by Genmab A/S, a Danish biotechnology company that trades under the ticker GMAB. Genmab is the sponsor behind the clinical program evaluating the antibody in head and neck cancer.
Zalutumumab has reached Phase 3 clinical development. Its Phase 3 trial enrolled patients with non-curable head and neck cancer. The program also includes earlier Phase 1 and Phase 2 studies. Zalutumumab is investigational and has not been approved by the FDA.
Zalutumumab has been studied in completed trials including NCT00382031, a Phase 3 study in non-curable head and neck cancer, NCT00542308, a Phase 2 study in non-curable squamous cell carcinoma of the head and neck, NCT01054625, a Phase 1/2 pharmacokinetics study, and NCT00093041, a Phase 1/2 study in head and neck neoplasms.
Across its clinical program, zalutumumab trials enrolled a total of 407 patients. The largest was the Phase 3 study NCT00382031 with 286 patients, followed by the Phase 2 study NCT00542308 with 90 patients. The Phase 1/2 studies enrolled 31 and 28 patients respectively.