Advancing Oncology Therapeutics: Innovative Approaches to Dose Optimisation in Phase I/II Trials (FDA Project Optimus)

The Oncology Center of Excellence (OCE) Project Optimus aims to refine dose optimisation in oncology by focusing on the safety and tolerability of a drug and not just efficacy.

The goals for Project Optimus include the undertaking to “Develop strategies for dose finding and dose optimization that leverages nonclinical and clinical data in dose selection, including randomized evaluations of a range of doses in trials. An emphasis of such strategies will be placed on performing these studies as early as possible in the development program and as efficiently as possible to bring promising new therapies to patients”.1

Our seminar, held in central London in June 2024, addressed some of the impacts of Project Optimus which we are beginning to see on some of our recent studies, as well as feedback from the FDA itself, which some of our sponsors have shared with us.

The agenda included a short introduction to Project Optimus, its objectives, challenges, and how a CRO such as Simbec-Orion can support sponsors in planning their early phase studies considering this initiative.

We then went on to cover the Impact of Project Optimus on your Clinical Development Plan, and discussed the corresponding Opportunities and Challenges in Statistical Design to Support Project Optimus application in our clinical trials


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