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Current commercial considerations reward first to market products leading to heightened emphasis on speed in oncology drug development. These headwinds disincentivize context appropriate dose-finding. This has shown up with targeted therapies and immunotherapies where the maximum tolerated dose is still the driver for dose selection even if not appropriate. Dose-finding designs that provide data on the trade-off between safety and efficacy are not commonly done. Patient convenience (e.g., fewer days hospitalized) are not considered until late in the life cycle of an oncology product. Dose-finding designs more customized to the product and indication are needed.
A case study involving a bi-specific T-cell engager will be discussed. The known features of these T-cell engagers will be utilized to introduce a novel design that uses intensive step dosing to efficiently explore the safety of a range of doses. As less frequent and more convenient dosing of T-cell engagers often leads to greater risk of safety issues, several methods to generate safety/efficacy data using multiple dose schedules with different levels of convenience will be proposed and evaluated.
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