Trials / Recruiting
RecruitingNCT05520099
Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform
Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform (ELEPHAS-02)
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 416 (estimated)
- Sponsor
- Elephas · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to develop and train the Elephas live tumor diagnostic platform and determine the ex-vivo accuracy of the Elephas Score using in-vivo RECIST 1.1 as the reference method
Detailed 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.
Conditions
- Immunotherapy
- Cancer
- Bladder Cancer
- Urothelial Carcinoma Bladder
- Kidney Cancer
- Clear Cell Renal Cell Cancer (ccRCC)
- Colorectal Cancer
- MSI-H Colorectal Cancer
- DMMR Colorectal Cancer
- Head and Neck Cancer (H&N)
- Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)
- Liver Cancer
- Hepatocellular Carcinoma (HCC)
- Lung Cancer (NSCLC)
- NSCLC (Non-small Cell Lung Cancer)
- Skin Cancer
- Cutaneous Melanoma
- Endometrial Cancer
- Solid Tumor Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Core Needle Biopsy, Forceps Biopsy, Punch Biopsy | Subjects must be clinically able, at investigator discretion, to undergo additional core needle biopsy, forceps biopsy, or punch 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. |
Timeline
- Start date
- 2023-06-26
- Primary completion
- 2027-01-01
- Completion
- 2027-01-01
- First posted
- 2022-08-29
- Last updated
- 2025-12-26
Locations
12 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05520099. Inclusion in this directory is not an endorsement.