Learn how dose expansion phases in early oncology trials reduce uncertainty before larger studies by confirming safety, exploring preliminary anti-tumour activity, and refining dose and schedule in the intended population.
In this explainer, we define what a dose expansion phase is, where it sits after dose escalation in a phase one programme, and why it matters for data managers, statisticians, and sponsors. You’ll hear how clear objectives, tight eligibility, and prespecified decision rules connect back to escalation findings and support a coherent transition to phase two. We outline practical design choices, including single or multiple cohorts by tumour type, biomarker status, or treatment line. You’ll learn which endpoints are most useful in this non-comparative setting, such as objective response rate, duration of response, and time on treatment, and how pharmacokinetic and pharmacodynamic data link exposure and target engagement to clinical observations.
At Quanticate, our biometrics teams help sponsors design, run, and analyse dose expansion cohorts that are compliant, efficient, and inspection ready. Submit an RFI today.