Recruiting

xDRIVE FPM AI

Sponsor:

First Ascent Biomedical Inc.

Code:

NCT07167381

Conditions

Cancer

Neoplams

Refractory

Recurrence

Leukaemia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

xDRIVE Tumor Profiling

Study Details

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

Study ID

NCT07167381

Start date

Nov 1, 2025

Status verified date

May, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

210 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: xDRIVE Profiling

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

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.

Primary outcome measure

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

Central Contacts and Locations

Locations

First Ascent Biomedical

Recruiting

Miami, Florida, United States, 33183

Contacts

Chandler Fox

757-634-7635cfox@firstascentbio.com

More Information

Sponsor

First Ascent Biomedical Inc.

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

  • Functional Precision Medicine
  • Artificial Intelligence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by First Ascent Biomedical Inc. on 2026-05-19.