xDRIVE for Florida-based Cancer Patients

NCT07167381 | Recruiting

• 2 other identifiers: FAB00000002Grant # 25C13
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Cancer; Neoplams; Refractory; Recurrence; Leukaemia; Lymphoma; Solid Tumor Malignancies; Solid Cancers

Keywords

Functional Precision Medicine; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• 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).

  Return of xDRIVE data will be completed in under 2 weeks

Secondary Outcomes (3)

• PFS Ratio ≥1.3x

  1 year after patient enrollment

• Objective Response Rate (ORR)

  1 year after enrollment

• Disease Control Rate (DCR)

  1 year after enrollment

Other Outcomes (3)

• Rates of actionable treatments

  Immediately following return of xDRIVE drug sensitivity testing and molecular tumor profiling data. Actionability will be tracked independent of treatment recommendations being returned within the 2 week timeframe for the primary objective

• Progression-free survival (PFS)

  1 year following enrollment

• Overall Survival (OS)

  1 year following enrollment

Study Arms (1)

xDRIVE Profiling

EXPERIMENTAL

Patients will receive tumor profiling via xDRIVE Functional Precision Medicine and Artificial Intelligence analysis

Diagnostic Test: xDRIVE Tumor Profiling

Interventions

xDRIVE Tumor Profiling DIAGNOSTIC_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.

xDRIVE Profiling

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Ascent Biomedical Inc.: lead

Study Sites (2)

First Ascent Biomedical

Miami, Florida, 33183, United States

RECRUITING

Florida International University

Miami, Florida, 33199, United States

ACTIVE NOT RECRUITING

Related Publications (2)

• 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.

  PMID: 39567286 BACKGROUND

• Acanda 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.

  PMID: 38605166 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Recurrence; Leukemia; Lymphoma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 11, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: If published, will be shared via open access publication.
• Access Criteria: Data will be anonymized and will be published in open access journal. Access will be enabled through the publication and associated data

Locations

US (2)