Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform (ELEPHAS-02)

April 24, 2026 updated by: Elephas

Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform (ELEPHAS-02)

The primary objective of this study is to develop and train the Elephas live tumor diagnostic platform and determine the ex-vivo accuracy of the Elephas Score using in-vivo RECIST 1.1 as the reference method

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Cancer is a leading cause of death and despite many new drugs, a major diagnostic challenge remains knowing which drug will work best for a patient. A new class of drugs called checkpoint inhibitors (CPIs) have revolutionized cancer treatment. However, current diagnostic methods (e.g. PDL1, MSI and TMB) do not accurately predict which patients will respond.

Elephas is developing a diagnostic platform using small 3D Live Tumor Fragments (LTFs) from participants for accurate prediction of drug response with a focus on CPIs such as Pembrolizumab (Keytruda). These LTFs contain both tumor cells and infiltrating immune cells, which are critical in determining response to CPIs and other immunotherapies.

In this observational clinical basket trial, participants will be recruited and their actual clinical response (using RECIST 1.1) to CPIs across five solid tumors (lung, head/neck, bladder, kidney, and skin) will be compared to the platform's predictive Artificial Intelligence (AI) score that is based on RNA, clinical data, and 3D microscopy images. The sensitivity and specificity of the platform's score will be determined and compared to current diagnostic methods for CPIs like PDL1, MSI, and TMB.

Study Type

Observational

Enrollment (Estimated)

416

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • CARTI Cancer Center
    • California
      • Salinas, California, United States, 93901
        • Salinas Valley Memorial Healthcare System
    • Florida
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando
      • Pembroke Pines, Florida, United States, 33026
        • Memorial Health System
      • Stuart, Florida, United States, 34994
        • Cleveland Clinic Florida
      • Tampa, Florida, United States, 33606
        • University of South Florida (Tampa General Hospital)
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville James Graham Brown Cancer Center
    • Maryland
      • Hagerstown, Maryland, United States, 21742
        • Meritus Center for Clinical Research
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center
    • New York
      • Buffalo, New York, United States, 14203
        • Roswell Park Comprehensive Cancer Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults aged 18 years or older, able to provide informed consent, and have a suspected or confirmed cancer diagnosis that meets requirements outlined in the eligibility criteria above.

Description

Inclusion Criteria --

  1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
  2. Age ≥ 18 years at the time of consent.

  3. Subjects must meet one of the following criteria:

    • Subjects suspected or diagnosed with recurrent, locally advanced or metastatic cancer:

      • Bladder: Urothelial Carcinoma (UC)
      • Kidney: Clear Cell Renal Cell Carcinoma (ccRCC)

    • Subjects suspected or diagnosed with recurrent or metastatic cancer:

      • Colon and Rectum: Microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) Colorectal Cancer (CRC)
      • Head and Neck: Squamous Cell Carcinoma (HNSCC), excluding nasopharyngeal and salivary gland cancers
      • Liver: Hepatocellular Carcinoma
      • Lung: Non-small cell lung cancer (NSCLC)
      • Skin: Cutaneous Melanoma, excluding Uveal Melanoma
      • Uterus: endometrial cancer

    • Subjects suspected or diagnosed with one of the following cancer types eligible for pure ICI neoadjuvant therapy:

      o Skin: Cutaneous Melanoma, Stage III

    • Subjects suspected or diagnosed with:

      • Any solid tumor type that is eligible for pure ICI therapy in the neoadjuvant or advanced/metastatic setting
      • Any metastatic solid tumor with high TMB, MSI-High or dMMR and are being considered for treatment with ICI therapy.
      • Any recurrent or metastatic patient with a solid tumor that the clinician plans to treat with ICI therapy.
  4. Subjects must be clinically able, at investigator discretion, to undergo a biopsy procedure
  5. Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment.

Exclusion Criteria --

  1. Subjects who are pregnant
  2. Subjects with a known auto-immune disease that would render them ineligible for immune-oncology treatment
  3. Immunocompromised subjects, and subjects known to be HIV positive and currently receiving antiretroviral therapy
  4. Subjects who are enrolled or plan to be enrolled in a blinded oncology treatment trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with suspected or diagnosed cancer types as listed in the description

Subjects suspected or diagnosed with recurrent, locally advanced or metastatic cancer: bladder (urothelial carcinoma), kidney (ccRCC).

Subjects suspected or diagnosed with recurrent or metastatic cancer: Colon and Rectum (MSI-H/dMMR Colorectal Cancer), Head and Neck (Squamous Cell Carcinoma), liver (Hepatocellular Carcinoma), Lung (NSCLC), Skin (Cutaneous Melanoma), Uterus (endometrial cancer).

Subjects suspected or diagnosed with one of the following cancer types eligible for pure ICI neoadjuvant therapy: Skin (Cutaneous Melanoma, Stage III)

Subjects suspected or diagnosed with: Any solid tumor type that is eligible for pure ICI therapy in the neoadjuvant or advanced/metastatic setting; Any metastatic solid tumor with high TMB, MSI-High or dMMR and are being considered for treatment with ICI therapy; Any recurrent or metastatic patient with a solid tumor that the clinician plans to treat with ICI therapy.
Procedure: Core Needle Biopsy, Forceps Biopsy, Punch Biopsy
Subjects must be clinically able, at investigator discretion, to undergo additional core needle biopsy, forceps biopsy, or punch biopsy passes during their biopsy. These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to additional passes (e.g., liver or lymph nodes) per the clinician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine Ex-Vivo Prognostic Accuracy of Elephas Platform
Time Frame: 3 years
The ex-vivo prognostic accuracy of the Elephas live tumor diagnostic platform will be determined using in-vivo RECIST 1.1 as the reference method.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establish AUC of ELEPHAS Score and Compare with FDA Approved Biomarkers
Time Frame: 3 years
The AUC of ELEPHAS Score will be established with a clinically meaningful confidence interval and compared to the AUCs of established FDA approved biomarkers for predicting clinical response to ICIs.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elephas

Collaborators

Hoosier Cancer Research Network

Investigators

  • Study Director: Fred Hausheer, MD, FACP, Elephas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2023

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

August 26, 2022

First Submitted That Met QC Criteria

August 26, 2022

First Posted (Actual)

August 29, 2022

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELEPHAS-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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