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.
Participants with mCRC who need clinical tumor biopsy or resection and need to start systemic therapy for measurable disease.
Case-only
Prospective
Functional precision medicine
Diagnostic testThe results of the drug sensitivity assay and genetic screening will be used to inform treating physician about patient-specific drug sensitivity or resistance guiding best therapy choices. Treatment will not be given as part of the study.
Accurate prediction of clinical benefit (complete response, partial response or stable disease) to physician-selected treatment among among enrolled patients with mCRC
The primary objective is to determine the accuracy of clinical benefit prediction by xDRIVE testing in participants with advanced CRC who receive SOC therapies. Response to SOC therapy will be determined by RECIST guidelines, with disease response measured through radiographic imaging. Accurate prediction of RECIST-determined clinical response (complete response, partial response, stable disease, or progressive disease) by xDRIVE tumor in 20 of 25 participants (80%) is sufficient to reject the null hypothesis (≤50% accuracy) with 90% power (α = 0.05). Enrollment will be a total of 30 subjects.
Feasibility of returning xDRIVE functional precision medicine data in a clinically-actionable timeframe
The secondary objective is to determine the feasibility of using xDRIVE to provide treatment recommendation in a clinically-actionable timeframe. Feasibility will be demonstrated if treatment recommendations are returned within 4 weeks for at least 16 of 25 patients (64%), which is sufficient to reject the null hypothesis (≤35% treatment recommendations) with 90% power (α = 0.05).
Assessment of physician experience with xDRIVE functional precision medicine through post-hoc questionnaire
The exploratory objective is to assess treating oncologists' perspective on the use of precision oncology platform in participants with advanced CRC, investigated through a post-hoc questionnaire of physician experience.
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First Ascent Biomedical Inc.
Lead sponsor
Mayo Clinic
Collaborator
Florida International University
Collaborator
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