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

Sponsor

Strata Oncology (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05312307

Collaborator

(none)

2,000

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer

Detailed Description

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 Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

May 1, 2027

Anticipated Study Completion Date :

May 1, 2030

Outcome Measures

Primary Outcome Measures

To identify subjects with RNA signatures who may be eligible for clinical trial enrollment [5 years]
The percentage of participants identified as eligible for therapeutic clinical trials.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Strata Oncology

Investigators

Study Director: Kat Kwiatkowski, PhD, Strata Oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Strata Oncology

ClinicalTrials.gov Identifier:

NCT05312307

Other Study ID Numbers:

STR-006-001

First Posted:

Apr 5, 2022

Last Update Posted:

Apr 5, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 5, 2022