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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cancer

Detailed Description

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa Hospitals & Clinics
      • Contact: Strata Oncology; Phone Number: 734-527-1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants are male or female ≥ 18 years of age; must have pathologically confirmed advanced, metastatic, or recurrent solid tumor; measurable disease; have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; must meet at least 1 of the following: a. Is/has not adequately responded to standard therapy, or b. For whom no life extending standard therapy exists, or c. Who decline standard therapy, or d. 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; have adequate cardiac, bone marrow, organ function & laboratory parameters as determined by the treating physician for potential participation in a clinical trial; have leftover formalin-fixed, paraffin-embedded (FFPE) tumor tissue available for StrataEXP testing.

Description

Inclusion Criteria:

1. Must be ≥18 years of age,
2. Participant must have pathologically confirmed advanced, metastatic, or recurrent solid tumor,
3. Measurable disease,
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2,

5. Participant must meet at least 1 of the following:

   1. Is/has not adequately responded to standard therapy, or
   2. For whom no life-extending standard therapy exists, or
   3. Who decline standard therapy, or
   4. 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
6. Adequate cardiac, bone marrow, organ function & laboratory parameters as determined by the treating physician for potential participation in a clinical trial,
7. Leftover formalin-fixed, paraffin-embedded (FFPE) tumor tissue available for StrataEXP testing

Exclusion Criteria:

1. Females who are pregnant or nursing,
2. History of stroke including transient ischemic attack (TIA) or acute myocardial infarction within 4 months of enrollment,
3. 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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Strata Oncology
• Investigators: Study Director: Kat Kwiatkowski, PhD, Strata Oncology

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Actual): February 22, 2024
• Study Completion (Actual): February 22, 2024

Study Registration Dates

• First Submitted: March 26, 2022
• First Submitted That Met QC Criteria: March 26, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STR-006-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No