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

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.

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Key information

Conditions

Cancer Advanced Solid Tumors Cancer Bladder Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Cancer Head and Neck Neoplasms Immunotherapy Intestinal Diseases Intestinal Neoplasms Kidney Cancer Kidney Diseases Kidney Neoplasms Liver Cancer Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms MSI-H Colorectal Cancer Male Urogenital Diseases Melanoma Melanoma (Skin Cancer) NSCLC (Non-small-cell Lung Cancer) Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Cancer Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases TNBC, Triple Negative Breast Cancer Thoracic Neoplasms Triple Negative Breast Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Diseases Uterine Neoplasms dMMR Colorectal Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mercy Hospital - FTS, Fort Smith, Arkansas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Able and willing to provide informed consent for participation
Age ≥18 years at time of consent.
Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy.
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

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.
Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.
Pregnant person(s).

Treatment and study plan

Biopsy

Procedure

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Elephas

Industry

Registry information

Official study title

Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies

Acronym: ELEPHAS-05

Important dates

Study start: 2025
Primary completion: 2035
Study completion: 2038
First posted: Jan 8, 2026
Registry last updated: Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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