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Florida cancer patients get AI-Powered personalized treatment plans in new study

NCT ID NCT07167381

Knowledge-focused Sponsor: First Ascent Biomedical Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether a new tool called xDRIVE, which combines artificial intelligence and tumor profiling, can quickly suggest personalized treatment options for cancer patients in Florida whose cancer has come back or not responded to standard treatments. The goal is to see if the tool can return useful recommendations within two weeks for at least 72% of the 210 participants, including children and underserved communities. If it works, this approach could help doctors make more informed treatment decisions for hard-to-treat cancers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
xDRIVE tumor profiling (diagnostic test using AI and drug sensitivity testing)
What this could lead to
If successful, this could show that AI-driven personalized treatment recommendations are feasible and help doctors choose better therapies for hard-to-treat cancers.
What could go wrong
This is an early feasibility study, not a treatment trial. It may not improve outcomes for all patients, and results depend on timely data return and physician use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 210 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cancer childhood leukemia leukemia lymphoma neoplasm Recurrence refractory malignant neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer Leukaemia Lymphoma Neoplams Recurrence Refractory Solid cancers Solid tumor malignancies

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • First Ascent Biomedical

    RECRUITING

    Miami, Florida, 33183, United States

  • Florida International University

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33199, United States

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