Joint Modeling of Safety & ctDNA to Support Recommended Phase 2 Dose Identification in Phase 1 Study
Time: 1:50 pm
day: Day 1 Track B PM
Details:
- Circulating tumor DNA (ctDNA)-based molecular response has been shown to predict clinical response earlier than RECIST response and is associated with long-term survival with different therapies across solid tumor types
- Beyond dose-limiting toxicity (DLT), pharmacodynamic markers or pharmacokinetics can be used to help identify optimal dosing of biologics
- We used an innovative integrative approach that factors in peripheral key mode of action biomarkers, ctDNA, and dose-limiting toxicity (DLT) rate from the Phase 1 HAMMER study (NCT04009681) to help identify the recommended Phase 2 dose (RP2D) for SAR444245
