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

(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?

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.

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+