Tissue Collection for Cancer Diagnosis

(CYBRID-02 Trial)

Recruiting at 10 trial locations

Overseen By Rebecca Mottier

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Elephas

Must be taking: ICI therapy

Must not be taking: Antiretrovirals

Disqualifiers: Auto-immune disease, Immunocompromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

216 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool, the Cybrid live tumor diagnostic platform, to assess its accuracy in predicting the behavior of various advanced cancers. It involves taking a tissue sample using a core needle biopsy, a procedure that extracts a small amount of tissue for examination, from participants diagnosed with or suspected of having certain advanced solid tumors, such as bladder, kidney, or lung cancer. The goal is to enhance doctors' ability to predict cancer progression and response to treatment. Individuals with a stage III or IV cancer diagnosis, or those suspected of having one of the specified cancers and able to undergo a biopsy, might be suitable for this trial. As a Phase 2 trial, this research focuses on evaluating the diagnostic platform's effectiveness in an initial, smaller group of people, offering participants the chance to contribute to advancements in cancer diagnostics.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the Cybrid live tumor diagnostic platform is safe?

Research has shown that the Cybrid Live Tumor Diagnostic Platform is generally safe for people. No evidence indicates that it causes harm when used to gather information about tumors. The process involves taking a small piece of tissue, known as a biopsy, which is a common medical procedure. Other studies have used this method to predict outcomes for various types of cancer, and it has not shown any serious side effects. While the platform itself is not a treatment, it aids doctors in understanding the tumor better, potentially leading to more personalized care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cybrid Live Tumor Diagnostic Platform because it aims to revolutionize how we diagnose and understand cancers, particularly advanced or metastatic ones. Unlike traditional diagnostic methods, which often rely on static tissue samples, this platform uses live tumor cells obtained through core needle biopsy to provide real-time insights into tumor behavior and treatment responses. By capturing and analyzing live cells, the platform may offer a more dynamic and precise picture of the cancer's characteristics, potentially leading to more tailored and effective treatment plans. This innovative approach could significantly enhance our ability to predict which therapies will be most effective for individual patients, paving the way for more personalized cancer care.

What evidence suggests that the Cybrid Live Tumor Diagnostic Platform is effective for diagnosing solid tumors?

In this trial, participants will be assessed using the Cybrid live tumor diagnostic platform, which research has shown could help predict a tumor's response to treatment. Studies have found that this platform can accurately forecast how different solid tumors, such as lung, kidney, and bladder cancers, will react to treatments. It tests tumor samples outside the body to observe their response to various treatments. Early results suggest it might assist doctors in selecting the best treatment options for patients. However, further research is needed to confirm its effectiveness for different types of cancer. ^{3 6 7 8 9}

Who Is on the Research Team?

Fred Hausheer, MD, FACP

Principal Investigator

Elephas

Are You a Good Fit for This Trial?

Inclusion Criteria

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.

Head and Neck: Squamous Cell Carcinoma (HNSCC), excluding nasopharyngeal and salivary gland cancers

Kidney: Clear Cell Renal Cell Carcinoma (ccRCC)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Tissue Collection

Participants' tumor tissues are collected to create 3D Live Tumor Fragments for diagnostic analysis

1-2 weeks

Diagnostic Analysis

The collected tumor tissues are analyzed using the Cybrid live tumor diagnostic platform to predict drug response

4-6 weeks

Follow-up

Participants' clinical responses to CPIs are monitored and compared to the platform's predictive score

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Core Needle Biopsy
• Cybrid Live Tumor Diagnostic Platform

How Is the Trial Designed?

Group I: Participants suspected of or diagnosed with Stage III or IV/metastatic cancer Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Elephas

Lead Sponsor

Trials

2

Recruited

420+

Elephas Biosciences Corporation

Collaborator

Trials

2

Recruited

540+

Hoosier Cancer Research Network

Collaborator

Trials

69

Recruited

3,800+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05520099

Study Details | NCT05520099 | Observational Basket Trial ... 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 ...

2. researchforme.unc.edu researchforme.unc.edu/study-details?rcid=5187

Tissue Sample Study (CYBRID-02) The purpose of this research is to collect a tissue sample (biopsies) and medical information, from you to help Elephas develop an investigational diagnostic ...

3. policylab.us policylab.us/clinical-trials/l/texas/condition/non-small-cell-lung-cancer?page=10

Texas Non-Small Cell Lung Cancer Paid Clinical Trials & Research ... 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06349642

Study Details | NCT06349642 | Predicting Response to ... This study is being done to collect tissue samples to test how accurately a tumor response platform, Elephas, can predict clinical response across multiple ...

5. ctv.veeva.com ctv.veeva.com/study/predicting-response-to-immune-checkpoint-inhibitors-across-solid-tumors-using-a-live-tumor-diagnosti

Predicting Response to Immune Checkpoint Inhibitors Across ... This study is being done to collect tissue samples to test how accurately a tumor response platform, Elephas, can predict clinical response across multiple ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05478538

Study Details | NCT05478538 | Observational Lung Trial to ... 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 ...

7. trials.braintumor.org trials.braintumor.org/trials/NCT05520099

Observational Basket Trial to Collect Tissue to Train and ... 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 ...

8. nycancer.com nycancer.com/trials/Elephas_CYBRID

CYBRID-01: Observational lung trial to collect tissue ... CYBRID-01: Observational lung trial to collect tissue to train and validate a live tumor diagnostic platform · Condition: Non-Small Cell Lung Cancer · Call Us.

9. breastcancertrials.org breastcancertrials.org/bct_nation/mts/mtsResult.seam?zip=94107&searchTerm1=basket&radiusMiles=-1

MTS Trials Purpose: To study the safety, effects (good and bad), and anti-cancer activity of using a tumor's genetic profile to select an FDA-approved targeted therapy ...