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

NCT ID: NCT05312307

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-06
• Study Completion Date: 2024-02-22

Brief Summary

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

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.

Conditions

Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Strata Oncology

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kat Kwiatkowski, PhD

Role: STUDY_DIRECTOR

Strata Oncology

Other Identifiers

STR-006-001

Identifier Type: -

Identifier Source: org_study_id