definiens: means a human clinical trial of a Product, the principal purpose of which is to evaluate safety in healthy individualsor patients, to determine pharmacokinetic parameters and other key pharmaceutical properties of the Product ( including absorption, metabolism, andelimination ), or to determine the appropriate range of doses to evaluate in further clinical trials, in each case as described in 21 C.F.R. § 312.21(a ), asamended from time to time, or the corresponding foreign regulation . However, Phase I Clinical Trial with oncology Products diﬀer from other Phase IClinical Trials in that they are evaluated in patients rather than healthy volunteers the goal of an oncology Phase I Clinical Trial is to find out if a Product issafe, ﬁnd the best route to administer the new treatment, and determine if there are signs that cancer responds to the new Product . An oncology Phase IClinial Trial usually includes 15 to 30 patients who are divided into small cohorts and the dose is increased with each new cohort until the best dose forfuture testing is established