Determining the dose to be injected in the first clinical trials with monoclonal antibodies: not so easy!

• Published in: M.S. Médecine sciences Vol. 35; no. 12; p. 1121
• Main Authors: Viala, Marie, Tosi, Diego
• Format: Journal Article
• Language: French
• Published: France 06.01.2020
• Subjects: Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal - adverse effects; Antineoplastic Agents, Immunological - administration & dosage; Antineoplastic Agents, Immunological - adverse effects; Clinical Trials as Topic - methods; Dose-Response Relationship, Immunologic; Drug Dosage Calculations; Drug-Related Side Effects and Adverse Reactions - prevention & control; Humans; Research Design - standards
• ISSN: 1958-5381
• DOI: 10.1051/medsci/2019209

Monoclonal antibodies are a therapeutic tool frequently used in oncology, as they allow the specific targeting of molecules expressed by cancer cells and, in most cases, induce minimal toxic effects on healthy tissues. Because monoclonal antibodies frequently lack significant toxicity and are not associated to a direct relationship between dose and effect, the methods of clinical development traditionally used for chemotherapy agents are scarcely useful for this class of drugs. In addition, no consensus exists on the definition of parameters different from toxicity that could assist the process of dose selection of monoclonal antibody in early clinical trials.