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Clinical Trials in the USA / NCT07167381
Recruiting Not applicable

xDRIVE for Florida-based Cancer Patients

NCT07167381 · tracked via the Priya Life Science USA tracker
Sponsor
First Ascent Biomedical Inc
Phase
Not applicable
Started
2025-11-01
Last updated
2026-05-19

Condition(s) studied

CancerNeoplamsRefractoryRecurrenceLeukaemiaLymphomaSolid Tumor MalignanciesSolid Cancers

Investigational drug(s) / intervention(s)

xDRIVE Tumor Profiling

xDRIVE Tumor Profiling: 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 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. 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).

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Return of treatment recommendations from xDRIVE functional precision medicine platform within a clinically-actionable timeframe — 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).

Trial sites (2)

FacilityCityRegionStatus
First Ascent Biomedical Miami Florida Recruiting
Florida International University Miami Florida Active Not Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07167381 on ClinicalTrials.gov ↗ ← All trials in the USA