Exposure‐tumour growth inhibition modelling of brigimadlin using phase I solid tumour data to support phase II dose selection

This research focuses on leveraging quantitative modeling to support dose selection in oncology drug development, presenting development of an exposure-tumour growth inhibition (E-TGI) model to investigate the relationship between brigimadlin exposure and tumour shrinkage using data from a phase I clinical trial. The aim was to support the selection of the recommended phase II dose (RP2D) for brigimadlin, a potent MDM2-p53 antagonist. 

• Exposure-response modeling: The E-TGI model characterized the relationship between brigimadlin exposure and tumour size dynamics
• Dose-response predictions: Simulations quantified tumour shrinkage associated with each proposed dose of brigimadlin.
• Dose selection: Based on these findings, 45 mg every 3 weeks was selected as the RP2D for phase II development

By improving understanding of dose-response relationships, these findings contribute to evidence-based decision-making in oncology drug development.