Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)

January 2, 2026 updated by: Elephas
This study will collect tumor specimens with correlated clinical and demographic data from patients who are undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up for suspected or confirmed cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Elephas is researching mechanisms of cutting, sorting and imaging tumors that leave the 3D tumor microenvironment (TME), including its immune cells, intact. This allows qualitative and semi-quantitative identification and characterization of the ex vivo response to exposure of potential immunotherapy. The ex vivo response data will then be compared to the clinical real world response data to inform development efforts.

This study will collect tumor specimens from patients with suspected or confirmed cancer. These specimens, along with clinical data and genomic data obtained as part of a patient's standard of care, will be used to perform this research.

Study Type

Observational

Enrollment (Estimated)

2000

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
      • Fort Smith, Arkansas, United States, 72903
        • Recruiting
        • Mercy Hospital - FTS
        • Principal Investigator:
          • Aswanth Reddy, MD
        • Contact:
    • Maryland
      • Frederick, Maryland, United States, 21702
        • Recruiting
        • Frederick Health Hospital
        • Principal Investigator:
          • Heather Chalfin, MD
        • Contact:
    • Missouri
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Hospital - SPG
        • Principal Investigator:
          • Mohan Tummala, MD
        • Contact:
      • St Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Hospital - South
        • Principal Investigator:
          • Yifan Tu
        • Contact:
      • St Louis, Missouri, United States, 63141
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Mercy Hospital - OKC
        • Contact:
        • Principal Investigator:
          • Carla Kurkjian
    • Texas
      • Forth Worth, Texas, United States, 76104
        • Recruiting
        • JPS Health Network
        • Contact:
        • Principal Investigator:
          • Paras Patel
      • Temple, Texas, United States, 76508
        • Not yet recruiting
        • Baylor Scott and White Biorepository
        • Contact:
        • Principal Investigator:
          • Mathew Bower, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults aged 18 years or older, who are able and willing to provide written informed consent, have a suspected or confirmed cancer diagnosis and will be undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up.

Description

Inclusion Criteria:

  1. Able and willing to provide informed consent for participation
  2. Age ≥18 years at time of consent.
  3. Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy.
  4. 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. Have a known auto-immune disease or prior condition (prior organ transplant, chronic kidney or liver disease) that renders them ineligible for immunotherapy (IO) treatment.
  2. Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.
  3. Pregnant person(s).

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Population
Adults aged 18 years or older, who are able and willing to provide written informed consent, have a suspected or confirmed cancer diagnosis and will be undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up.
Procedure: Biopsy
Subjects must be clinically able, at investigator discretion, to undergo additional biopsy passes during their biopsy. Biopsy specimen(s) will be obtained during a standard of care (SOC) procedure. If a subject receives a subsequent SOC biopsy for clinical diagnosis purposes, additional sample(s) may be collected and sent to the Sponsor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors & Researching Mechanisms of Tumor Cutting and Imaging
Time Frame: Study duration is approximately 36 months from enrollment to end of study.
Collect human tumor specimens to research mechanisms of tumor cutting, imaging, and ex-vivo immunotherapy treatment response, while maintaining cell stability in a live tumor microenvironment.
Study duration is approximately 36 months from enrollment to end of study.

Collaborators and Investigators

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

Sponsor

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)

April 14, 2025

Primary Completion (Estimated)

April 1, 2035

Study Completion (Estimated)

April 1, 2038

Study Registration Dates

First Submitted

December 19, 2025

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELEPHAS-05

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

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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