Accelerating Phase 1 decisions with liquid biopsy: From early signals to actionable insights

Phase 1 oncology studies play a critical role in establishing safety, dose selection, and early signs of clinical activity. However, meaningful efficacy readouts often emerge only after substantial enrollment and follow-up, delaying key development decisions. When promising signals are absent — or when unexpected biological findings emerge — late-stage pivots can significantly increase development timelines, costs, and operational complexity.

Recent advances in liquid biopsy and epigenomic profiling offer the opportunity to generate molecular insights earlier in clinical development. By leveraging non-invasive blood-based approaches, biopharma teams can evaluate tumor dynamics, molecular response, and biologic activity before traditional endpoints mature, helping inform development strategy with greater confidence.

Attendees will learn:

• Why relying solely on traditional clinical endpoints in Phase 1 studies can delay critical development decisions and increase program risk.
• How emerging liquid biopsy technologies can provide earlier visibility into treatment response, biological activity, and patient heterogeneity.
• The utility of non-destructive methylation profiling, tumor fraction assessment, and methylation-based signatures for generating translational insights from a simple blood draw.
• How molecular response assessments may complement conventional efficacy endpoints to support dose optimization and expansion cohort strategy.
• Real-world examples demonstrating how ctDNA and epigenomic biomarkers informed dosing decisions, patient selection strategies, and early signal detection in oncology development programs.
• Practical considerations for incorporating liquid biopsy endpoints into Phase 1 study design to accelerate learning and reduce uncertainty in early development.