The study aims to evaluate the clinical utility of the xDRIVE functional precision medicine + artificial intelligence (AI) platform in predicting treatment response for metastatic colorectal cancer (mCRC). The primary objective is to assess xDRIVE's accuracy in forecasting clinical benefit from standard-of-care (SOC) therapies, with a target of ≥80% accuracy in 25 participants. Achieving this threshold would provide sufficient statistical power to reject the null hypothesis of ≤50% accuracy.
The secondary goal is to determine the feasibility of utilizing xDRIVE for timely treatment recommendations. Success will be defined by the ability to provide recommendations within four weeks for at least 64% of patients, ensuring clinical applicability.
Additionally, the study includes an exploratory objective to examine oncologists' perspectives on integrating xDRIVE into clinical decision-making. This will be achieved through a post-hoc survey assessing physician experiences with the precision oncology platform.
Participants (men and women) enrolled in internal review board (IRB) 622-00 and meet the following criteria.
Participants ≥18 years of age with a diagnosis of mCRC who are willing to consent to the study
Participants with Eastern Cooperative Group (ECOG) performance status of 0, 1, or 2.
Participants with measurable disease
Participants who do not have malignant tissue available or safely accessible or do not have sufficient amount of tissue from anticipated biopsy, excision or resection for testing.
Participants who do not have measurable disease.
Participants with insufficient health indicators to undergo therapeutic intervention for mCRC based on treating oncologist's clinical assessment.
Participants with other concurrent cancers besides mCRC which also require ongoing cancer-directed therapy.
First Ascent Biomedical Inc.
Lead sponsor
Mayo Clinic
Collaborator
Florida International University
Collaborator