Strata EXPress™: A Study Using StrataEXP™ to Identify RNA-Expression Biomarkers in Advanced Cancer Patients

Study Overview
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Brief Summary
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The primary goal of this study is to identify patients with RNA expression profiles consistent with eligibility requirements for therapeutic clinical trials across solid tumors. Left-over tumor tissue will be collected from eligible participants for RNA expression analysis using next-generation sequencing.

Detailed Description
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The primary goal of this study is to identify patients with RNA expression profiles consistent with eligibility requirements for therapeutic clinical trials across solid tumors. Left-over tumor tissue will be collected from eligible participants for RNA expression analysis using next-generation sequencing. A parallel study, StrataPATH™ (STR-004-001), has been developed to support therapeutic hypotheses. Participants may be consented and screened for enrollment separately into StrataPATH with an eligible matching biomarker/drug treatment cohort upon positive identification of a relevant expression signature. Treatment effectiveness of antibody drug conjugates and other targeted therapies will be evaluated in these molecularly defined cohorts.

Official Title
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Strata EXPress™: A Study Using StrataEXP™ to Identify RNA-Expression Biomarkers in Advanced Cancer Patients

Conditions
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Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be ≥18 years of age, Participant must have pathologically confirmed advanced, metastatic, or recurrent solid tumor, Measurable disease, Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2, Participant must meet at least 1 of the following: Is/has not adequately responded to standard therapy, or For whom no life-extending standard therapy exists, or Who decline standard therapy, or In the opinion of the investigator, is not a candidate for or would be unlikely to tolerate or derive significant clinical benefit from standard therapy Adequate cardiac, bone marrow, organ function & laboratory parameters as determined by the treating physician for potential participation in a clinical trial, Leftover formalin-fixed, paraffin-embedded (FFPE) tumor tissue available for StrataEXP testing Exclusion Criteria: Females who are pregnant or nursing, History of stroke including transient ischemic attack (TIA) or acute myocardial infarction within 4 months of enrollment, Any other clinically significant medical condition that, in the opinion of the treating physician, makes participation in a clinical trial undesirable, including but not limited to ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify subjects with RNA signatures who may be eligible for clinical trial enrollment | The percentage of participants identified as eligible for therapeutic clinical trials. | 5 years |