xDRIVE for Florida-based Cancer Patients

Официальное название

xDRIVE Functional Precision Medicine + Artificial Intelligence Individualized Treatments for Florida-based Cancer Patients With Relapsed/ Refractory Cancers

Обзор

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).

Подробное описание

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.

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

• Return of treatment recommendations from xDRIVE functional precision medicine platform within a clinically-actionable timeframe [Срок оценки: Return of xDRIVE data will be completed in under 2 weeks]

Вторичные конечные точки (3)

• PFS Ratio ≥1.3x [Срок оценки: 1 year after patient enrollment]
• Objective Response Rate (ORR) [Срок оценки: 1 year after enrollment]
• Disease Control Rate (DCR) [Срок оценки: 1 year after enrollment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• First Ascent Biomedical — Miami
• Florida International University — Miami

Публикации

• 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
• 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. PMID 38605166

Идентификаторы

NCT: NCT07167381 · FAB00000002 · Grant # 25C13

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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