Translational PK/PD and the first-in-human dose selection of a PD1/IL15: an engineered recombinant targeted cytokine for cancer immunotherapy.

After the first dose, AUC 0-∞ showed a trend of slightly exceeding the dose proportionality However, upon repeat dosing, a substantial decrease (27%–44% decrease across tested dose levels) in exposure (AUC 0-∞ ) was observed compared with the first dose.

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There was a slight trend for decrease in C max with repeated dosing; however, the ranges (mean ± SD) for C max overlapped after the first, second, and third doses.

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