xDRIVE personalized tumor testing for Florida cancer patients
xDRIVE Functional Precision Medicine + Artificial Intelligence Individualized Treatments for Florida-based Cancer Patients With Relapsed/ Refractory Cancers
This program will try a functional precision medicine and AI platform (xDRIVE) to help guide next treatment options for Florida patients with recurrent or refractory cancer, including children and people from underserved communities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Sex | All |
| Sponsor | First Ascent Biomedical Inc. Industry-sponsored |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT07167381 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm feasibility program enrolling 210+ Florida patients with recurrent or refractory cancers to deliver the xDRIVE Functional Precision Medicine (FPM) platform combined with artificial intelligence. Sites will obtain tumor tissue (biopsy, excision, or resection) and matched normal material (blood or buccal swab) for ex vivo drug testing and molecular profiling; results are returned to the treating physician to inform next-line therapy. The study emphasizes inclusion of pediatric patients and adults from Black, Brown, Hispanic, and rural communities and also collects health economics data to measure cost and access impacts. The primary focus is statewide feasibility and clinical utility of providing the xDRIVE platform outside major tertiary centers.
Who should consider this trial
Good fit: Ideal candidates are Florida residents with recurrent or refractory cancer (pediatric patients up to 18 years or adults ≥18) who have had at least one prior standard therapy, can provide prior treatment and outcome information, have adequate performance status (ECOG 0–2 for adults), and have accessible tumor tissue for testing.
Not a fit: Patients without sufficient or accessible malignant tissue, those too medically frail for further cancer therapy (e.g., ECOG >2), newly diagnosed patients who have not received prior therapy, or people unable to provide required samples or treatment information are unlikely to benefit.
Why it matters
Potential benefit: If successful, the program could help identify personalized drug options and improve access to tailored therapies for underserved Florida patients, possibly improving outcomes and reducing travel-related costs.
How similar studies have performed: A related feasibility study in advanced pediatric solid and hematologic cancers (NCT03860376) reported positive results that were published in Nature Medicine, demonstrating prior success with this functional precision medicine approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Miami, Florida and 1 other locations
- First Ascent Biomedical — Miami, Florida, United States (Recruiting)
- Florida International University — Miami, Florida, United States (Active_not_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.