xDRIVE in Metastatic Colorectal Cancer

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.

NCT Number	NCT06929338
Lead Sponsor	First Ascent Biomedical Inc. Collaborators: Mayo Clinic, Florida International University
Conditions	Metastatic Colon Adenocarcinoma, Metastatic Colon Cancer, Metastatic Rectal Adenocarcinoma, Metastatic Rectal Carcinoma, Metastatic Rectum Cancer
Enrollment	30 participants
Start Date	2025-09-15
Primary Completion	2026-06-30 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-09-16