Actively Recruiting

Phase Not Applicable
All Genders
ID07167381

xDRIVE Functional Precision Medicine and Artificial Intelligence Individualized Treatments for Florida-based Cancer Patients with Relapsed or Refractory Cancers

Led by First Ascent Biomedical Inc. · Updated on 2026-05-19

210

Participants Needed

2

Research Sites

21 weeks

Total Duration

On this page

Sponsors

F

First Ascent Biomedical Inc.

Lead Sponsor

F

Florida International University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the feasibility of providing the xDRIVE Functional Precision Medicine and Artificial Intelligence platform to cancer patients across Florida, especially those from underserved groups such as pediatric patients and minorities. This study aims to assess patient clinical benefit and health economic impacts by offering personalized cancer treatment support to patients with relapsed or refractory cancers. The program builds on previous promising results demonstrating actionable treatment recommendations and improved progression-free survival in pediatric patients with aggressive cancers. Participants in this single-arm feasibility study will undergo tumor profiling using the xDRIVE platform. This platform analyzes tumor samples to generate individualized treatment recommendations, which are returned to the treating physician within two weeks and may be used to guide the patient's next line of therapy. The study includes both pediatric and adult patients who have relapsed or refractory cancers and have received prior standard therapy. Blood or buccal swab samples will also be collected for matched normal DNA comparison during profiling. During the study, patients will provide tumor tissue through biopsy, excision, or resection, and treatment and outcome information from prior therapies. The research team will review progression-free survival, objective response rate, and disease control rate one year after enrollment. The study focuses on monitoring the return of treatment recommendations within a clinically actionable timeframe and gathering data on clinical benefit and health economics. Participation includes blood draws or swabs and clinical follow-up as needed, with the total study duration varying by patient.

CONDITIONS

Brief Title

xDRIVE for Florida-based Cancer Patients

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with recurrent or refractory cancer up to age 18 who are willing to sign assent if ages 7 to 17 years
  • Patients with recurrent or refractory cancer aged 18 years or older
  • Patients who have received at least one prior line of standard of care therapy
  • Patients able to provide treatment and outcome information from previous therapies
  • Patients with sufficient health status to undergo cancer therapy (ECOG performance status 0, 1, or 2 for adults)
  • Patients scheduled for or who have recently undergone tumor biopsy, excision, or resection
  • Patients willing to have a blood draw or buccal swab for matched normal DNA for tumor profiling
Not Eligible

You will not qualify if you...

  • Patients without malignant tissue available or accessible
  • Patients with insufficient malignant tissue for ex vivo drug testing or genetic profiling (less than 0.3g for resections or core/fine-needle biopsies without malignant tissue)
  • Patients with insufficient health indicators to undergo therapeutic intervention

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Return of xDRIVE data will be completed in under 2 weeks

Participants undergo tumor profiling via xDRIVE Functional Precision Medicine and Artificial Intelligence analysis to inform their next line of cancer treatment.

1 visit for tumor biopsy or sample collection

Follow-up

Duration - 1 year after enrollment

Participants are monitored for treatment outcomes such as progression-free survival and response rates over the course of 1 year after enrollment.

Periodic follow-up visits as determined by the treating physician

Trial Site Locations

Total: 2 locations

1

First Ascent Biomedical

Miami, Florida, United States, 33183

Actively Recruiting

2

Florida International University

Miami, Florida, United States, 33199

Active, Not Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Similar Trials

Use of [F-18] FLT for Imaging With Positron Emission Tomogra...

Brain and Central Nervous System Tumors

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Feasibility of functional precision medicine for guiding treatment of relapsed or refractory pediatric cancers.

Arlet M Acanda De La Rocha, Noah E Berlow, Maggie Fader...

https://pubmed.ncbi.nlm.nih.gov/38605166