Abstract: Provided herein are methods for adaptive design of a treatment regimen for treatment of subjects with a therapeutic agent. In some embodiments, the methods can determine the optimal dosing regimen, such as dose level and/or schedule to administer to a subject. In some embodiments, the methods can be used for determining dosing regimens in clinical trials, such as Phase I clinical trials. In some embodiments, one or more of or all of the steps of the method occur at an electronic device containing one or more processors and memory, such as implemented by a computer. Also provided are methods of administering a therapeutic agent to a subject in accord with an adaptive dosing regimen designed to identify an optimal dose and/or schedule of a therapeutic agent for treating a disease or condition.