xDRIVE Tumor Profiling for Cancer

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: First Ascent Biomedical Inc.

Disqualifiers: Insufficient malignant tissue, Insufficient health, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

210 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called the xDRIVE Functional Precision Medicine + Artificial Intelligence platform, which assists doctors in determining the best next steps in cancer treatment. By analyzing a patient's tumor, the platform can identify which therapies might be most effective, potentially improving outcomes and reducing costs. The trial is open to patients with difficult-to-treat cancers who have previously tried standard therapies and can provide details of those treatments. Participants must have had a recent tumor biopsy or surgery and be prepared for a blood test or cheek swab for further analysis. As an unphased study, this trial allows patients to contribute to cutting-edge research that could shape future cancer treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the xDRIVE Functional Precision Medicine + Artificial Intelligence platform is safe for cancer patients?

Research has shown that the xDRIVE Functional Precision Medicine + Artificial Intelligence platform is promising in terms of safety. This platform uses AI to analyze cancer tumors and identify the most effective treatments from those already approved by the FDA. It does not involve administering a new drug but aids doctors in selecting the most effective existing treatments.

As xDRIVE primarily serves as a decision-making tool, it does not present direct safety concerns like new medications might. The focus is on using AI to determine which treatments might work best for each patient, so the platform itself does not have side effects like a drug.

Overall, the platform is considered safe because it relies on treatments that are already approved, making safety a minor concern with this approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the xDRIVE Functional Precision Medicine and Artificial Intelligence platform because it offers a personalized approach to cancer treatment. Unlike traditional methods that often rely on a one-size-fits-all strategy, xDRIVE uses advanced AI to analyze a patient's tumor at a molecular level. This allows for highly tailored treatment options that can potentially improve effectiveness and outcomes. By leveraging cutting-edge technology, xDRIVE aims to match patients with the most effective therapies faster and more accurately than ever before.

What evidence suggests that the xDRIVE platform is effective for cancer?

Research has shown that the xDRIVE Functional Precision Medicine + Artificial Intelligence platform, provided to participants in this trial, can enhance cancer treatment outcomes. AI technology identifies new markers, improving the accuracy of cancer diagnosis and treatment. Evidence from First Ascent Biomedical indicated that patients with hard-to-treat cancers benefit 83% more from this approach compared to traditional methods. This platform combines drug testing, genetic analysis, and AI to offer personalized cancer treatment options. These advancements suggest that xDRIVE might effectively improve progression-free survival, measuring how long patients live without their cancer worsening. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for Florida-based cancer patients up to age 18, or adults with recurrent/refractory cancers. Participants must have had at least one standard treatment and be healthy enough for therapy (ECOG status 0-2). They should provide past treatment data, agree to a biopsy and blood draw or cheek swab, and aim to help underserved communities.

Inclusion Criteria

I am 18 or younger with cancer that has come back or didn’t respond to treatment.

I am 18 or older with cancer that has come back or didn't respond to treatment.

I have undergone at least one standard treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

2 weeks

Data returned within 2 weeks for treatment recommendations

Follow-up

Participants are monitored for disease control and progression-free survival

1 year

What Are the Treatments Tested in This Trial?

Interventions

• xDRIVE Functional Precision Medicine + Artificial Intelligence platform

Trial Overview The xDRIVE Functional Precision Medicine + AI platform is being tested in this study. It profiles tumors to guide future treatments. The single-arm feasibility study will enroll over 210 patients across Florida, returning results to doctors for informed decision-making on subsequent therapies.

How Is the Trial Designed?

Group I: xDRIVE Profiling Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

First Ascent Biomedical Inc.

Lead Sponsor

Trials

1

Recruited

70+

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT07167381

NCT07167381 | xDRIVE for Florida-based Cancer Patients Progression-free survival (PFS), Individual cancer types with sufficient patient enrollment and outcomes will be compared against historical PFS data, 1 year ...

2. ctv.veeva.com ctv.veeva.com/study/xdrive-for-florida-based-cancer-patients

xDRIVE for Florida-based Cancer Patients - ClinicalTrials.Veeva Notably, 5-year overall survival rates for children with certain aggressive subtypes often fall below 30%. Similarly, adult cancer patients, especially those in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9846804/

Artificial intelligence assists precision medicine in cancer ... AI can find new biomarkers from data to assist tumor screening, detection, diagnosis, treatment and prognosis prediction.

4. clpmag.com clpmag.com/disease-states/cancer/ai-driven-platform-aims-bring-personalized-cancer-treatment-more-patients/

AI-Driven Platform Aims to Bring Personalized Cancer ... First Ascent Biomedical's published clinical evidence shows that refractory cancer patients benefit 83% better than a functional precision ...

5. fightcolorectalcancer.org fightcolorectalcancer.org/advocacy/research-advocacy/funded-researchers/

Funded Researchers | Fight CRC By integrating functional drug testing, genetic analysis, and artificial intelligence, First Ascent's xDRIVE platform will provide oncologists ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07167381

NCT07167381 | xDRIVE for Florida-based Cancer Patients Patients and physicians will receive tumor profiling data via xDRIVE Functional Precision Medicine and Artificial Intelligence analysis. As this is a ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11957836/

Hallmarks of artificial intelligence contributions to precision ... In this Review, we discuss ten AI hallmarks in precision oncology, organized into three groups: (1) cancer prevention and diagnosis, encompassing cancer ...

8. oncologycompass.com oncologycompass.com/digest/issue14/

THE POWER OF FUNCTIONAL PRECISION MEDICINE IN ... The article explores how ex vivo tumor sample testing, drug responsiveness analysis, and resistance profiling are reshaping decision making in oncology.

9. ehoonline.biomedcentral.com ehoonline.biomedcentral.com/articles/10.1186/s40164-022-00333-7

Introducing AI to the molecular tumor board: one direction ... Introducing cutting-edge artificial intelligence (AI) technology and information and communication technology to MTBs while reducing the burden on MTB members.