Optimizing dose selection in oncology: the rationale for the clinical dose selection of giredestrant, an oral selective estrogen receptor degrader

Key Points

• This research aims to challenge the traditional maximum tolerated dose (MTD) approach in drug development for oncology therapies.
• Analysis of the traditional MTD paradigm in drug development.
• Evaluation of evidence-based dose selection methods.
• Integration of preclinical data into clinical dose determination.
• The research highlights the limitations of the MTD approach.
• Demonstrates the need for a broader base of evidence in dose selection.
• Suggests that informed dose selection may enhance the clinical development of targeted therapies.