A Feasibility Study to Evaluate a Precision Oncology Platform (xDRIVE) in Participants With Advanced Colorectal Cancer
Trial ID: NCT06929338
Status: NOT_YET_RECRUITING
Study type: OBSERVATIONAL
Start date: 2025-09-15
Completion date: 2027-06-30
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
Interventions: Functional precision medicine
Enrollment: 30
Age range: 18 Years - None
Sex: ALL

Summary:
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.

Eligibility criteria:
Inclusion Criteria:

* 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 need to start SOC cancer-directed systemic therapy
* Participants able to provide treatment and outcome information from previous lines of therapy.
* Participants who will need a tumor biopsy, excision, or resection as part of their routine clinical care.
* Participants willing to have a blood draw performed for matched normal material.
* Participants who plan to have their first radiographic assessment of their cancer at Mayo Clinic.

Exclusion Criteria:

* 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 who cannot provide an informed consent.

Outcomes:
Accurate prediction of clinical benefit (complete response, partial response or stable disease) to physician-selected treatment among among enrolled patients with mCRC