xDRIVE for Florida-based Cancer Patients

NCT ID: NCT07167381

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-04-01

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).

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; Solid Tumor Malignancies; Solid Cancers

Keywords

Functional Precision Medicine; Artificial Intelligence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

xDRIVE Profiling

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

Group Type: EXPERIMENTAL

xDRIVE Tumor Profiling

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Ascent Biomedical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

First Ascent Biomedical

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Chandler Fox

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 39567286 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38605166 (View on PubMed)

Other Identifiers

FAB00000002

Identifier Type: -

Identifier Source: org_study_id