xDRIVE for Florida-based Cancer Patients

ConditionsCancer Neoplams Refractory Recurrence Leukaemia Lymphoma Solid Tumor Malignancies Solid Cancers

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorFirst Ascent Biomedical Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

210 Participants

are divided into 1 treatment group

Group A: xDRIVE ProfilingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

Return of xDRIVE data will be completed in under 2 weeks

Secondary outcomes

PFS Ratio ≥1.3x

Progression-free survival (PFS) ratio ≥1.3x (ratio of program PFS vs. previous PFS) in patients guided by xDRIVE individualized treatments or by treatment of physician's choice. PFS ratio ≥1.3x in 30%+ of at least 62 patients, below our published rate of 83%, will provide \>85% power (α = 0.025) to reject the null hypothesis (\<15% PFS ratio ≥1.3).

Time frame

1 year after patient enrollment

Objective Response Rate (ORR)

Objective responses in 45%+ in at least 76 patients, below our published 83% ORR, will provide \>85% power (α = 0.025) to reject the null hypothesis (\<30% ORR).

Time frame

1 year after enrollment

Disease Control Rate (DCR)

Disease control in 62%+ in at least 76 patients will provide \>85% power (α = 0.025) to reject the null hypothesis (\<45% ORR).

Time frame

1 year after enrollment

Other outcomes

Rates of actionable treatments

Rates of actionable treatments from genomic tumor profiling versus xDRIVE profiling

Time frame

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)

Individual cancer types with sufficient patient enrollment and outcomes will be compared against historical PFS data

Time frame

1 year following enrollment

Overall Survival (OS)

Individual cancer types with sufficient patient enrollment and outcomes will be compared against historical PFS data

Time frame

1 year following enrollment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Ascent Biomedical Inc.

Lead sponsor

Florida International University

Collaborator

Source ClinicalTrials.gov

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