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Med Sci (Paris). 2019 Dec;35(12):1121-1129. doi: 10.1051/medsci/2019209. Epub 2020 Jan 6.

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

[Article in French; Abstract available in French from the publisher]

Author information

1
Unité d'Essais de Phase Précoce (UEPP), Institut du Cancer de Montpellier (ICM), Montpellier, France.
2
Unité d'Essais de Phase Précoce (UEPP), Institut du Cancer de Montpellier (ICM), Montpellier, France - Institut de Recherche en Cancérologie de Montpellier (IRCM), Inserm U1194, Montpellier, France.

Abstract

in English, French

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.

PMID:
31903926
DOI:
10.1051/medsci/2019209

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