xDRIVE in Metastatic Colorectal Cancer

First Ascent Biomedical Inc.

Status

Not yet enrolling

Conditions

Metastatic Rectum Cancer

Metastatic Rectal Carcinoma

Metastatic Rectal Adenocarcinoma

Metastatic Colon Adenocarcinoma

Metastatic Colon Cancer

Treatments

Diagnostic Test: Functional precision medicine

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06929338

FAB00000001

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.