Metastatic Colon AdenocarcinomaNCT06929338
xDRIVE in Metastatic Colorectal Cancer
An observational study of Metastatic Colon Adenocarcinoma and Metastatic Colon Cancer, run by First Ascent Biomedical Inc..
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colon Adenocarcinoma, Metastatic Colon Cancer, Metastatic Rectal Adenocarcinoma
- What is being tested?
- Functional precision medicine
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 30 Jun 2027
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with mCRC who need clinical tumor biopsy or resection and need to start systemic therapy for measurable disease.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Metastatic Colon Adenocarcinoma, Metastatic Colon Cancer, Metastatic Rectal Adenocarcinoma, Metastatic Rectal Carcinoma, Metastatic Rectum Cancer
- Being tested
- Functional precision medicine
- Keywords
- functional precision medicine, artificial intelligence, molecular tumor profiling, metastatic colorectal cancer
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional precision medicineDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic colorectal cancer patients | Participants with mCRC who need clinical tumor biopsy or resection and need to start systemic therapy for measurable disease. Receives: Diagnostic Test: Functional precision medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: Timeframe for successful return of data is within 4 weeks. Previous studies have demonstrated a median 10-day turnaround time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start15 Sep 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Why it stopped: Unable to finalize study agreements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colon AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Ascent Biomedical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic, Florida International University
- Responsible party
- Sponsor
- Investigators
- Noah Berlow, PhD, Principal investigator, First Ascent BiomedicalHao Xie, MD PhD, Principal investigator, Mayo ClinicLisa Boardman, MD, Principal investigator, Mayo ClinicDiana J Azzam, PhD, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929338
- Sponsor's protocol ID
- FAB00000001
- Status last verified
- Aug 2026
- First submitted
- 27 Mar 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 39567286Acanda 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.
PubMed 38605166
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate a Precision Oncology Platform (xDRIVE) in Participants With Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06929338
- Acronym / sponsor ID
- FAB00000001
- 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
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to finalize study agreements
- Enrolment
- 0 participants (actual)
- Lead sponsor
- First Ascent Biomedical Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic, Florida International University
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic colorectal cancer patients | – | Diagnostic Test: Functional precision medicineParticipants with mCRC who need clinical tumor biopsy or resection and need to start systemic therapy for measurable disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with mCRC who need clinical tumor biopsy or resection and need to start systemic therapy for measurable disease.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional precision medicineThe 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. | Diagnostic test | Metastatic colorectal cancer patients |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 39567286Acanda 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.
- Background: PubMed 38605166Acanda 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Berlow, PhD principal investigator
First Ascent Biomedical
Hao Xie, MD PhD principal investigator
Mayo Clinic
Lisa Boardman, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colon Adenocarcinoma and Metastatic Colon Cancer, run by First Ascent Biomedical Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06929338, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.