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

Colorectal Cancer Clinical Trial

— CYBRID-02  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05520099
• Other study ID #: HCRN BSK22-562
• Status: Recruiting
• Start date: June 26, 2023
• Est. completion date: January 2027

Study information

• Verified date: May 2024
• Source: Elephas
• Contact: Catarina Costa
• Phone: 609 955 4927
• Email: ClinicalTrials[@]elephas.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

1. 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.

2. Age = 18 years at the time of consent.

3. Subjects must meet one of the following criteria:

• 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. NOTE: This can be either in the setting of a trial, compassionate use, or the use of appropriate LDT tests that per clinician, render the patient eligible for ICI therapy, either frontline or a later line.

4. Subjects must be clinically able, at investigator discretion, to undergo additional core needle or forceps biopsy passes during their biopsy.

5. 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.

6. Subjects with a newly confirmed diagnosis who have previously undergone a standard of care biopsy must be willing to undergo a separate biopsy procedure solely for the purposes of this study.

7. Female subjects must not be pregnant.

8. Subjects with a known auto-immune disease that would render them ineligible for immune-oncology treatment are not eligible.

9. Immunocompromised subjects, and subjects known to be HIV positive and currently receiving antiretroviral therapy are not eligible. NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.

10. Subjects who are enrolled or plan to be enrolled in a blinded oncology treatment trial are not eligible.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Renal Cell
• Carcinoma, Squamous Cell
• Carcinoma, Transitional Cell
• Clear Cell Renal Cell Carcinoma
• Colorectal Cancer
• Cutaneous Melanoma
• Endometrial Cancer
• Endometrial Neoplasms
• Head and Neck Squamous Cell Carcinoma
• Melanoma
• Non Small Cell Lung Cancer
• Squamous Cell Carcinoma of Head and Neck
• Urothelial Carcinoma

Intervention

Procedure:
• Core Needle or Forceps Biopsy
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.

Locations

Country	Name	City	State
United States	Roswell Park Comprehensive Cancer Center	Buffalo	New York
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	John Theurer Cancer Center	Hackensack	New Jersey
United States	University of Louisville James Graham Brown Cancer Center	Louisville	Kentucky
United States	University of Wisconsin	Madison	Wisconsin
United States	AdventHealth Orlando	Orlando	Florida
United States	Salinas Valley Memorial Healthcare System	Salinas	California
United States	Cleveland Clinic Florida	Stuart	Florida
United States	University of South Florida (Tampa General Hospital)	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Elephas	Hoosier Cancer Research Network

Country where clinical trial is conducted

United States, 

References & Publications (2)

Chen S, Zhang Z, Zheng X, Tao H, Zhang S, Ma J, Liu Z, Wang J, Qian Y, Cui P, Huang D, Huang Z, Wu Z, Hu Y. Response Efficacy of PD-1 and PD-L1 Inhibitors in Clinical Trials: A Systematic Review and Meta-Analysis. Front Oncol. 2021 Apr 16;11:562315. doi: 10.3389/fonc.2021.562315. eCollection 2021. — View Citation

Cherukuri AR, Lubner MG, Zea R, Hinshaw JL, Lubner SJ, Matkowskyj KA, Foltz ML, Pickhardt PJ. Tissue sampling in the era of precision medicine: comparison of percutaneous biopsies performed for clinical trials or tumor genomics versus routine clinical care. Abdom Radiol (NY). 2019 Jun;44(6):2074-2080. doi: 10.1007/s00261-018-1702-1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and Specificity of Cybrid Score for Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors	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.	3 years
Secondary	Determine the Area Under the Receiver Operating Characteristic Curve (AUC) of Cybrid Score and Compare to the AUCs of Current FDA Approved Predictive Biomarkers PD-L1 and Tumor Mutation Burden (TMB)	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.	3 years