Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Immune Checkpoint Inhibitors

Immunomodulating Agents

Liver Extracts

Subjects suspected of or diagnosed with Stage IV NSCLC and meet one of the following criteria:

1. Subjects who are undiagnosed, have undergone imaging and are suspected to have Stage IV lung cancer.
2. Subjects with a Stage I, II, or III diagnosis of NSCLC, who are being re-biopsied after imaging-confirmed progression to metastatic disease
3. Subjects who have a confirmed diagnosis of NSCLC, and have undergone a SOC biopsy procedure and will undergo a separate procedure for the purposes of this study.
4. Subjects who have a previous Stage IV/metastatic NSCLC diagnosis and have already received first line treatment.

Subjects must be clinically able, at investigator discretion, to undergo additional core needle or forceps 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.

Core Needle or Forceps Biopsy

Catarina Costa

Saima Chaabane

Fereidoun Abtin, MD

Ingrid Halvorson

Heather Chalfin, MD

Laura Parisi

Richard Zuniga, MD

April Bell

Paras Patel, MD

Lorie A Fares

Andrea G Mosko

Alan Gowan, DO

Fred Hausheer, MD, FACP

The primary objective of this study is to determine the ex-vivo prognostic accuracy of the Cybrid live tumor diagnostic platform using in-vivo RECIST 1.1 as the reference method.

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 immune checkpoint inhibitors (ICIs) 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 ICIs such as Pembrolizumab (Keytruda). These LTFs contain both tumor cells and infiltrating immune cells, which are critical in determining response to ICIs and other immunotherapies.

In this observational clinical trial, 200 Non-Small Cell Lung Cancer (NSCLC) participants will be recruited and their actual clinical response to ICIs (using RECIST 1.1) 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 ICIs like PDL1, MSI, and TMB.

Fresh tissue sampling using core needle or forceps biopsy.

Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform

Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform (CYBRID-01)

The ex-vivo prognostic accuracy of the Cybrid live tumor diagnostic platform will be determined using in-vivo RECIST 1.1 as the reference method.

The AUC of Cybrid 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.

Elephas

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Melanoma

Carcinoma, Transitional Cell

Carcinoma, Squamous Cell

Carcinoma, Renal Cell

Melanoma, Cutaneous Malignant

Endometrial Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neoplasms, Squamous Cell

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Head and Neck Neoplasms

Transitional Cell Carcinoma

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

Herbal and Botanical

Cola

Subjects suspected or diagnosed with Stage III or IV:

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

Subjects suspected or diagnosed with Stage IV/metastatic:

* 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
* Lung: Non-small cell lung cancer (NSCLC)
* Skin: Cutaneous Melanoma, excluding Uveal Melanoma
* Uterus: endometrial cancer

Subjects suspected or diagnosed with:

* Any metastatic solid tumor with high TMB, MSI-High or dMMR and are being considered for treatment with ICI therapy.
* Any metastatic solid tumor that the clinician plans to treat with ICI therapy.

Rae Richards

Juan Morales

Geetha Varma, MD

Joseph Dunn

Mark Socinski, MD

Irene Ball

Kelley Kozma, MS, DO

Jennifer Burgess

Matthew Anderson, MD, PhD

Danial Malik

Robert Martin, MD, PhD

Diane Russomanno

John Gibbs, MD

John Gaeddert

Edwin Yau, MD, PhD

Markeela Lipscomb

Desma Jones

Nima Kokabi, MD

Sara John

Giuseppe Toia, MD, MS

The primary objective of this study is to determine the ex-vivo prognostic accuracy of the Cybrid live tumor diagnostic platform across a basket of solid tumors, using in-vivo RECIST 1.1 as the reference method.

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.

Fresh tissue sample using core needle biopsy or forceps biopsy.

Observational Basket Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform

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

Hoosier Cancer Research Network

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform	NCT05478538	Non Small Cell ... Metastatic Non ... NSCLC Metastatic NSCL...	Core Needle or ...	18 Years -	Elephas
Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform	NCT05478538	Non Small Cell ... Metastatic Non ... NSCLC Metastatic NSCL...	Core Needle or ...	18 Years -	Elephas
Observational Basket Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform	NCT05520099	Colorectal Canc... Head and Neck S... Non Small Cell ... Cutaneous Melan... Endometrial Can... Urothelial Carc... Clear Cell Rena...	Core Needle or ...	18 Years -	Elephas
Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform	NCT05478538	Non Small Cell ... Metastatic Non ... NSCLC Metastatic NSCL...	Core Needle or ...	18 Years -	Elephas

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