Abstract
Experimental oncotherapeutics programs have been in place at major academic centres for over four decades. The emergence of molecular targeting agents and the recent introduction of immuno-oncology drugs have expanded the scope and eligibility for first-in-human trials. Improved understanding of tumor biology coupled with the ability to screen for tumor associated targets, as well as, genetic alterations have heralded the era of personalized (personalized or precision) cancer treatment. Molecular targeting agents with their improved tolerability and sustained responses compared to conventional cytotoxic chemotherapy have contributed to remarkable improvements in clinical outcomes Dramatic phase 1 observations of anti-tumor activity of novel molecules in the relapsed or refractory setting have ofen led to their investigation as monotherapy or in combinatorial strategies early in the course of cancer treatment. Studies have thus evolved from the traditional role of dose and toxicity-fnding studies to innovative enrichment study designs which match patients with study agents, thus increasing the potential of clinical efcacy, even in the early dose escalation setting.
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