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

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Elephas

No Placebo Group

Trial Summary

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.

Research Team

Fred Hausheer, MD, FACP

Principal Investigator

Elephas

Eligibility Criteria

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.

Age ≥ 18 years at the time of consent.

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

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Treatment Details

Interventions

Core Needle Biopsy (Procedure)
Cybrid Live Tumor Diagnostic Platform (Diagnostic Test)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Participants suspected of or diagnosed with Stage III or IV/metastatic cancerExperimental Treatment1 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.