xDRIVE in Metastatic Colorectal Cancer

September 10, 2025 updated by: First Ascent Biomedical Inc.

A Feasibility Study to Evaluate a Precision Oncology Platform (xDRIVE) in Participants With Advanced 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants with mCRC who need clinical tumor biopsy or resection and need to start systemic therapy for measurable disease.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Metastatic colorectal cancer patients
Participants with mCRC who need clinical tumor biopsy or resection and need to start systemic therapy for measurable disease.
Diagnostic test: Functional precision medicine
The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accurate prediction of clinical benefit (complete response, partial response or stable disease) to physician-selected treatment among among enrolled patients with mCRC
Time Frame: Tumor measurements will be taken at baseline before treatment and at the first post-treatment scan. RECIST will be used to assess response. Outcomes will be tracked for the duration of the study, up to one year.

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.
Tumor measurements will be taken at baseline before treatment and at the first post-treatment scan. RECIST will be used to assess response. Outcomes will be tracked for the duration of the study, up to one year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of returning xDRIVE functional precision medicine data in a clinically-actionable timeframe
Time Frame: Timeframe for successful return of data is within 4 weeks. Previous studies have demonstrated a median 10-day turnaround time.
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).
Timeframe for successful return of data is within 4 weeks. Previous studies have demonstrated a median 10-day turnaround time.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of physician experience with xDRIVE functional precision medicine through post-hoc questionnaire
Time Frame: Post-hoc questionnaire will initiated at baseline and will be completed within 2 weeks following radiographic imaging of patient response. Questionnaires will be performed on a per-participating physician basis.
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.
Post-hoc questionnaire will initiated at baseline and will be completed within 2 weeks following radiographic imaging of patient response. Questionnaires will be performed on a per-participating physician basis.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Ascent Biomedical Inc.

Collaborators

Mayo Clinic
Florida International University

Investigators

  • Principal Investigator: Noah Berlow, PhD, First Ascent Biomedical
  • Principal Investigator: Hao Xie, MD PhD, Mayo Clinic
  • Principal Investigator: Lisa Boardman, MD, Mayo Clinic
  • Principal Investigator: Diana J Azzam, PhD, Florida International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

March 27, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAB00000001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Participant Data (IPD) will be kept only at the clinical site and only for the purpose of tracking patient enrollment and outcomes, and will not be shared even with other sites in the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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