Bolster your biomarker data in phase 1 using backfill

Dose escalation studies can make predictive biomarker analysis tricky. But leveraging backfill in Phase 1 can be a game-changer.

Here’s why backfill enrollment can boost your study:

🚀 Enhances data collection: Gather more data to identify the optimal biological dose (OBD) without slowing down the trial.
⏳ Maintains momentum: Enroll patients into backfill while awaiting DLT data for the current dose level.
🎯 Boosts predictive power: Limit backfill to biomarker or indication-specific groups, strengthening your biomarker analysis.

Ying Yuan recently shared some great insights on integrating backfill into trial design at #AACR25. Check out the resources in the comments! 👇

💡 Pro Tip: Use PD biomarkers to determine when to define drug activity and open backfill—don’t just rely on response alone.

What strategies are you using to make predictive biomarker analysis more robust in early-phase trials?