Abstract

In recent years, development of cancer therapies has been accelerated more than ever before. Within the traditional phase 1, 2 and 3 clinical trials, safety and efficacy are simultaneously assessed in phase 1 trials, and expansion cohorts are being conducted to assess the efficacy of treatments for each cancer type and to determine optimal biomarkers. It is important to be able to select patients with stable general health and to conduct paired biopsy (pre-treatment/after treatment/at tumor progress timing) in early phase trials to enable earlier cancer selection for drug development and biomarker development.

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