A Multi-Arm Two-Stage (MATS) Design for Proof-of-Concept and Dose Optimization in Early-Phase Oncology Trials

Zhenghao Jiang, Gu Mi, Ji Lin +2

The Project Optimus initiative by the FDA's Oncology Center of Excellence is widely viewed as a groundbreaking effort to change the $\text{status quo}$ of conventional dose-findi…