xDRIVE in Metastatic Colorectal Cancer

Metastatic colorectal cancer (mCRC) remains a critical unmet clinical need, necessitating innovative approaches to improve patient outcomes. Functional precision medicine (FPM)-guided interventions offer the potential to enhance treatment decision-making by tailoring therapies based on individual patient responses. This study aims to evaluate the clinical utility of xDRIVE, a precision oncology platform, in predicting treatment response to standard-of-care (SOC) therapies in patients with advanced colorectal cancer. By integrating cutting-edge biobanking and personalized medicine approaches, the study seeks to determine whether xDRIVE can provide accurate and timely treatment recommendations, ultimately optimizing clinical management for patients with mCRC. The primary objective is to assess the accuracy of xDRIVE in predicting clinical benefit, defined as a complete response, partial response, or stable disease. Success will be determined by achieving at least 80% accuracy in 20 of 25 participants, allowing for rejection of the null hypothesis (≤50% accuracy) with 90% statistical power. A total of 30 participants will be enrolled to ensure robust evaluation. The secondary objective is to evaluate the feasibility of utilizing xDRIVE in a clinically actionable timeframe, with success defined as delivering treatment recommendations within four weeks for at least 64% of cases. This feasibility threshold will allow for rejection of the null hypothesis (≤35% feasibility) with 90% power. Additionally, the study will explore oncologists' perspectives on integrating xDRIVE into clinical decision-making. A post-hoc survey will be conducted to assess physician experiences, providing insights into the potential impact and adoption of precision oncology platforms in routine practice.