CancerNCT07167381
xDRIVE for Florida-based Cancer Patients
A study testing xDRIVE Tumor Profiling in people with Cancer and Neoplams, run by First Ascent Biomedical Inc. at 2 sites in United States.
Trial summary
Through this study funded by the Florida Cancer Innovation Fund, First Ascent will demonstrate state-wide feasibility of providing xDRIVE Functional Precision Medicine + Artificial Intelligence platform by assessing patient clinical benefit and health economics impacts. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer, Neoplams, Refractory
- What is being tested?
- xDRIVE Tumor Profiling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2025to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with recurrent/refractory cancer patients up to age 18 (willing to sign assent if ages 7 - 17 years)
- -OR- Patients with recurrent/refractory cancer ≥18 years of age.
- Patients who have received at least one prior line of standard of care therapy.
- Patients able to provide treatment and outcome information from previous line(s) of therapy.
- Patients with sufficient health status to undergo cancer therapy, e.g., Eastern Cooperative Group (ECOG) performance status of 0, 1, or 2 for adult patients.
- Patients who are scheduled for or have recently undergone a tumor biopsy, excision, or resection.
- Patients willing to have a blood draw or buccal swab performed for matched normal material for comparison during tumor DNA profiling.
Who cannot join
- Patients who do not have malignant tissue available and accessible, patients where the amount of excised malignant tissue is insufficient material for ex vivo drug testing and/or genetic profiling, defined as <0.3g for resections or core/fine-needle biopsies not containing malignant tissue by pathology review, or insufficient malignant tissue in peripheral blood or bone marrow aspirate samples.
- Patients with insufficient health indicators to undergo therapeutic intervention.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
First Ascent Biomedical
Miami, Florida, 33183
Chandler Fox, 757-634-7635, cfox@firstascentbio.com
- Active, not recruiting
Florida International University
Miami, Florida, 33199
About this study
Official title: xDRIVE Functional Precision Medicine + Artificial Intelligence Individualized Treatments for Florida-based Cancer Patients With Relapsed/ Refractory Cancers
Through this study funded by the Florida Cancer Innovation Fund, First Ascent will demonstrate state-wide feasibility of providing xDRIVE Functional Precision Medicine + Artificial Intelligence platform by assessing patient clinical benefit and health economics impacts. As this is a feasibility study, results will be returned to the physician and the physician may use the data to inform the next line of treatment. The investigator will run a prospective single-arm feasibility study providing the xDRIVE FPM AI platform to n = 210+ cancer patients throughout the state of Florida, especially those from underserved populations (pediatric patients and patients in Black, Brown, Hispanic, and rural communities).
Read the detailed description
Cancer remains a leading cause of death in Florida, presenting formidable challenges across different patient populations resulting in over with 138,000 deaths in the previous 5 years. For children, cancer is the leading cause of death by disease, with pediatric malignancies often being particularly aggressive. Notably, 5-year overall survival rates for children with certain aggressive subtypes often fall below 30%. Similarly, adult cancer patients, especially those in minority and rural communities, face significant health and economic disparities that impede their access to care and contribute to poorer outcomes. For both pediatric and adult patients, these challenges are often compounded by systemic barriers, including insurance denials for potentially effective off-label drug use and the prohibitive cost of travel required to access specialized care at major cancer centers. To address these critical gaps, First Ascent is opening a clinical program, funded by the Florida Cancer Innovation Fund, that will provide cutting-edge personalized cancer treatment to cancer patients throughout Florida. The program will provide the xDRIVE Functional Precision Medicine (FPM) and Artificial Intelligence platform to serve both pediatric and adult patients, with a particular focus on ensuring access for underserved communities.
Results from the clinical feasibility study on advanced pediatric solid and hematological cancers (NCT03860376) recently published in Nature Medicine demonstrated that 21 of 24 patients (87.5%) enrolled in the clinical trial had actionable treatment recommendations returned within median 10 days. Additionally, 83% (5/6) of FPM-guided patients had >30% longer progression-free survival (PFS) compared to their own previous regimens, with a median 8.5-fold increase in PFS. In contrast, only 13% (1/8) patients in the physician's choice arm had >30% longer PFS. These ongoing clinical programs serving patients at Nicklaus Children's Hospital and Cleveland Clinic Florida have demonstrated the feasibility and clinical benefit of xDRIVE FPM, which has been extended to patients around Florida and around the country. Updated outcomes from the ongoing FPM studies demonstrate that 92% of patients receive individualized treatment recommendations, and 95% of patients receive clinical benefit from FPM-guided treatment, even in heavily-pretreated recurrent/refractory patients.
- Conditions
- Cancer, Neoplams, Refractory, Recurrence, Leukaemia, Lymphoma
- Being tested
- xDRIVE Tumor Profiling
- Keywords
- Functional Precision Medicine, Artificial Intelligence
- Medical subject headings
- Neoplasms, Recurrence, Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xDRIVE Tumor ProfilingDiagnostic test
Patients and physicians will receive tumor profiling data via xDRIVE Functional Precision Medicine and Artificial Intelligence analysis. As this is a feasibility study, results will be returned to the physician and the physician may use the data to inform the next line of treatment.
| Study group | Role | What they receive |
|---|---|---|
| xDRIVE Profiling | Experimental | Patients will receive tumor profiling via xDRIVE Functional Precision Medicine and Artificial Intelligence analysis Receives: Diagnostic Test: xDRIVE Tumor Profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return of treatment recommendations from xDRIVE functional precision medicine platform within a clinically-actionable timeframe
Tumor tissues provided by patients will undergo drug sensitivity testing and molecular tumor profiling in order to identify individualized treatment options. Treatment recommendations from both tumor profiling methods will be returned to the patient and physician to support clinical decision-making. Return of data in a timeframe fast enough to support decision-making is critical for showing clinical feasibility of this approach around the state of Florida. Feasibility will be demonstrated if xDRIVE treatment recommendations are returned within 2 weeks for at least 151 of 210 patients (72%), which is sufficient to reject the null hypothesis (≤60% of patients receiving treatment recommendations) with >95% power (α = 0.025).
Measured: Return of xDRIVE data will be completed in under 2 weeks
Secondary outcomes (3)
PFS Ratio ≥1.3x
Progression-free survival (PFS) ratio ≥1.3x (ratio of program PFS vs. previous PFS) in patients guided by xDRIVE individualized treatments or by treatment of physician's choice. PFS ratio ≥1.3x in 30%+ of at least 62 patients, below our published rate of 83%, will provide >85% power (α = 0.025) to reject the null hypothesis (<15% PFS ratio ≥1.3).
Measured: 1 year after patient enrollment
Objective Response Rate (ORR)
Objective responses in 45%+ in at least 76 patients, below our published 83% ORR, will provide >85% power (α = 0.025) to reject the null hypothesis (<30% ORR).
Measured: 1 year after enrollment
Disease Control Rate (DCR)
Disease control in 62%+ in at least 76 patients will provide >85% power (α = 0.025) to reject the null hypothesis (<45% ORR).
Measured: 1 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Nov 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
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 CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Ascent Biomedical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Florida International University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167381
- Sponsor's protocol ID
- FAB00000002
- Other IDs
- Grant # 25C13
- Status last verified
- May 2026
- First submitted
- 24 Aug 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient cancer types and relevant clinical outcomes data will be shared.
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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- xDRIVE Functional Precision Medicine + Artificial Intelligence Individualized Treatments for Florida-based Cancer Patients With Relapsed/ Refractory Cancers
- ClinicalTrials.gov ID
- NCT07167381
- Acronym / sponsor ID
- FAB00000002
- Conditions
- Cancer, Neoplams, Refractory, Recurrence, Leukaemia, Lymphoma
- Keywords
- Functional Precision Medicine, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- First Ascent Biomedical Inc.Industry (pharma, biotech, devices)
- Collaborators
- Florida International University
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 11 Sep 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.
Through this study funded by the Florida Cancer Innovation Fund, First Ascent will demonstrate state-wide feasibility of providing xDRIVE Functional Precision Medicine + Artificial Intelligence platform by assessing patient clinical benefit and health economics impacts. As this is a feasibility study, results will be returned to the physician and the physician may use the data to inform the next line of treatment. The investigator will run a prospective single-arm feasibility study providing the xDRIVE FPM AI platform to n = 210+ cancer patients throughout the state of Florida, especially those from underserved populations (pediatric patients and patients in Black, Brown, Hispanic, and rural communities).
Detailed description
Cancer remains a leading cause of death in Florida, presenting formidable challenges across different patient populations resulting in over with 138,000 deaths in the previous 5 years. For children, cancer is the leading cause of death by disease, with pediatric malignancies often being particularly aggressive. Notably, 5-year overall survival rates for children with certain aggressive subtypes often fall below 30%. Similarly, adult cancer patients, especially those in minority and rural communities, face significant health and economic disparities that impede their access to care and contribute to poorer outcomes. For both pediatric and adult patients, these challenges are often compounded by systemic barriers, including insurance denials for potentially effective off-label drug use and the prohibitive cost of travel required to access specialized care at major cancer centers. To address these critical gaps, First Ascent is opening a clinical program, funded by the Florida Cancer Innovation Fund, that will provide cutting-edge personalized cancer treatment to cancer patients throughout Florida. The program will provide the xDRIVE Functional Precision Medicine (FPM) and Artificial Intelligence platform to serve both pediatric and adult patients, with a particular focus on ensuring access for underserved communities.
Results from the clinical feasibility study on advanced pediatric solid and hematological cancers (NCT03860376) recently published in Nature Medicine demonstrated that 21 of 24 patients (87.5%) enrolled in the clinical trial had actionable treatment recommendations returned within median 10 days. Additionally, 83% (5/6) of FPM-guided patients had >30% longer progression-free survival (PFS) compared to their own previous regimens, with a median 8.5-fold increase in PFS. In contrast, only 13% (1/8) patients in the physician's choice arm had >30% longer PFS. These ongoing clinical programs serving patients at Nicklaus Children's Hospital and Cleveland Clinic Florida have demonstrated the feasibility and clinical benefit of xDRIVE FPM, which has been extended to patients around Florida and around the country. Updated outcomes from the ongoing FPM studies demonstrate that 92% of patients receive individualized treatment recommendations, and 95% of patients receive clinical benefit from FPM-guided treatment, even in heavily-pretreated recurrent/refractory patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| xDRIVE Profiling | Experimental | Diagnostic Test: xDRIVE Tumor ProfilingPatients will receive tumor profiling via xDRIVE Functional Precision Medicine and Artificial Intelligence analysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with recurrent/refractory cancer patients up to age 18 (willing to sign assent if ages 7 - 17 years)
- -OR- Patients with recurrent/refractory cancer ≥18 years of age.
- Patients who have received at least one prior line of standard of care therapy.
- Patients able to provide treatment and outcome information from previous line(s) of therapy.
- Patients with sufficient health status to undergo cancer therapy, e.g., Eastern Cooperative Group (ECOG) performance status of 0, 1, or 2 for adult patients.
Key exclusion criteria (2 listed)
- Patients who do not have malignant tissue available and accessible, patients where the amount of excised malignant tissue is insufficient material for ex vivo drug testing and/or genetic profiling, defined as <0.3g for resections or core/fine-needle biopsies not containing malignant tissue by pathology review, or insufficient malignant tissue in peripheral blood or bone marrow aspirate samples.
- Patients with insufficient health indicators to undergo therapeutic intervention.
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 |
|---|---|---|
| xDRIVE Tumor ProfilingPatients and physicians will receive tumor profiling data via xDRIVE Functional Precision Medicine and Artificial Intelligence analysis. As this is a feasibility study, results will be returned to the physician and the physician may use the data to inform the next line of treatment. | Diagnostic test | xDRIVE Profiling |
Primary outcome
Return of treatment recommendations from xDRIVE functional precision medicine platform within a clinically-actionable timeframe
Time frame: Return of xDRIVE data will be completed in under 2 weeks
Tumor tissues provided by patients will undergo drug sensitivity testing and molecular tumor profiling in order to identify individualized treatment options. Treatment recommendations from both tumor profiling methods will be returned to the patient and physician to support clinical decision-making. Return of data in a timeframe fast enough to support decision-making is critical for showing clinical feasibility of this approach around the state of Florida. Feasibility will be demonstrated if xDRIVE treatment recommendations are returned within 2 weeks for at least 151 of 210 patients (72%), which is sufficient to reject the null hypothesis (≤60% of patients receiving treatment recommendations) with >95% power (α = 0.025).
3 secondary outcomes
PFS Ratio ≥1.3x
Time frame: 1 year after patient enrollment
Objective Response Rate (ORR)
Time frame: 1 year after enrollment
Disease Control Rate (DCR)
Time frame: 1 year after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 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: Yes. Patient cancer types and relevant clinical outcomes data will be shared.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing xDRIVE Tumor Profiling in people with Cancer and Neoplams, run by First Ascent Biomedical Inc. at 2 sites in United States.
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 7 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return of treatment recommendations from xDRIVE functional precision medicine platform within a clinically-actionable timeframe (time frame: Return of xDRIVE data will be completed in under 2 weeks). 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 NCT07167381, 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 19 May 2026.