Southwest Early Clinical Trials Consortium

University Of Tx Md Anderson Can Ctr, Houston TX

Investigators

Linked publications & trials

Abstract

Precision Oncology through Multiplex Testing for AntibodyDrug Conjugate Targets We propose to launch a target of interest (TOI) Nanostring assay for clinical trial enrollment in two steps. In the first phase, we would establish the Nanostring assay in the MD Anderson pre-CLIA lab. After initial analytic validation, this assay will be launched as a prescreening tool, to screen patients for multiple targets in the pre-CLIA environment. Patients with expression of TOI can undergo prescreening with CLIA central diagnostic (such as CLIA IHC) for enrollment in specific trials. As the second phase, after experience with the assay in the pre-CLIA environment and confirmation of that correlation of RNA with protein expression for TOIs in subsequent cohorts, the TOI assay will be transitioned to the CLIA assay to serve as a standalone diagnostic for selected agents. In this proposal we propose to establish the TOI assay in the pre-CLIA environment in order to test the feasibility and clinical utililty in an ADC-MATCH trial through ET-CTN.