Clinical trial NCT06929338: xDRIVE in Metastatic Colorectal Cancer
Official title: A Feasibility Study to Evaluate a Precision Oncology Platform (xDRIVE) in Participants With Advanced Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: First Ascent Biomedical Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

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.

Primary outcomes:
measure: Accurate prediction of clinical benefit (complete response, partial response or stable disease) to physician-selected treatment among among enrolled patients with mCRC
timeFrame: 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:
measure: Feasibility of returning xDRIVE functional precision medicine data in a clinically-actionable timeframe
timeFrame: Timeframe for successful return of data is within 4 weeks. Previous studies have demonstrated a median 10-day turnaround time.
Other outcomes:
measure: Assessment of physician experience with xDRIVE functional precision medicine through post-hoc questionnaire
timeFrame: 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.
Locations:
Study officials:
affiliation: First Ascent Biomedical
name: Noah Berlow, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Hao Xie, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Lisa Boardman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.