Clinical trial NCT05312307: Strata EXPress™: A Study Using StrataEXP™ to Identify RNA-Expression Biomarkers in Advanced Cancer Patients
Official title: Strata EXPress™: A Study Using StrataEXP™ to Identify RNA-Expression Biomarkers in Advanced Cancer Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cancer
Lead sponsor: Strata Oncology
Sponsor class: INDUSTRY
First posted: 2022-04-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: To identify subjects with RNA signatures who may be eligible for clinical trial enrollment
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Strata Oncology
name: Kat Kwiatkowski, PhD
role: STUDY_DIRECTOR
References: