xDRIVE in Metastatic Colorectal Cancer

NCT06929338 | Not Yet Recruiting

• 1 other identifier: FAB00000001
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Metastatic Colon Adenocarcinoma; Metastatic Colon Cancer; Metastatic Rectal Adenocarcinoma; Metastatic Rectal Carcinoma; Metastatic Rectum Cancer

Keywords

functional precision medicine; artificial intelligence; molecular tumor profiling; metastatic colorectal cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (1)

• Feasibility of returning xDRIVE functional precision medicine data in a clinically-actionable timeframe

  Timeframe for successful return of data is within 4 weeks. Previous studies have demonstrated a median 10-day turnaround time.

Other Outcomes (1)

• Assessment of physician experience with xDRIVE functional precision medicine through post-hoc questionnaire

  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.

Study Arms (1)

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

Interventions

Functional precision medicine DIAGNOSTIC_TEST

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.

Metastatic colorectal cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Ascent Biomedical Inc.: lead
• Mayo Clinic: collaborator
• Florida International University: collaborator

Related Publications (2)

• Acanda de la Rocha AM, Berlow NE, Azzam DJ. Functional precision medicine: the future of cancer care. Trends Mol Med. 2025 May;31(5):404-408. doi: 10.1016/j.molmed.2024.10.015. Epub 2024 Nov 19.

  PMID: 39567286 BACKGROUND

• Acanda De La Rocha AM, Berlow NE, Fader M, Coats ER, Saghira C, Espinal PS, Galano J, Khatib Z, Abdella H, Maher OM, Vorontsova Y, Andrade-Feraud CM, Daccache A, Jacome A, Reis V, Holcomb B, Ghurani Y, Rimblas L, Guilarte TR, Hu N, Salyakina D, Azzam DJ. Feasibility of functional precision medicine for guiding treatment of relapsed or refractory pediatric cancers. Nat Med. 2024 Apr;30(4):990-1000. doi: 10.1038/s41591-024-02848-4. Epub 2024 Apr 11.

  PMID: 38605166 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Live tumor tissue samples with DNA and RNA isolated for tumor profiling and treatment identification

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noah E Berlow, PhD

CONTACT

18063708119; nberlow@firstascentbio.com

James Foote, MBA

CONTACT

13602811620; jfoote@firstascentbio.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 16, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share