Active Not RecruitingNot applicableNCT05520099

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

Checked against the public recordLast updated Jun 29, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhaseNot applicable
U.S. locations12
SponsorElephas
01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Elephas
Interventions being studied
Procedure: Core Needle Biopsy, Forceps Biopsy, Punch Biopsy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • CARTI Cancer CenterLittle Rock, Arkansas
  • Salinas Valley Memorial Healthcare SystemSalinas, California
  • AdventHealth OrlandoOrlando, Florida
  • Memorial Health SystemPembroke Pines, Florida
  • Cleveland Clinic FloridaStuart, Florida
  • University of South Florida (Tampa General Hospital)Tampa, Florida
  • University of Louisville James Graham Brown Cancer CenterLouisville, Kentucky
  • Meritus Center for Clinical ResearchHagerstown, Maryland
  • John Theurer Cancer CenterHackensack, New Jersey
  • Roswell Park Comprehensive Cancer CenterBuffalo, New York
  • University of North Carolina at Chapel HillChapel Hill, North Carolina
  • University of WisconsinMadison, Wisconsin

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 29, 2026. Always confirm current availability with the study team.

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