Discover the impact of Project Optimus on your oncology trial

Key aims in early oncology development are to estimate the recommended Phase 2 dose (RP2D) and investigate which patient populations are optimal for further development.

Moreover, the FDA Project Optimus initiative requires the examination of more than one dose prior to pivotal trials. This talk will outline the types of available dose escalation designs and highlight the evolving Basket designs that investigate biomarker-defined patient populations. The role of PK/PD modeling in determining the RP2D and schedule will also be emphasized.

Key topics

• Dose Escalation Design Options
• Basket Study Design Options
• PK/PD Modelling for identifying the RP2D

Speakers

• James Matcham, VP Strategic Consulting
• Michael Fössler, VP Strategic Consulting