Clinical trial NCT05097599: StrataPATH™ (Precision Indications for Approved Therapies)
Official title: StrataPATH™ (Precision Indications for Approved Therapies): A Study Evaluating the Clinical Activity and Safety of Approved Drugs Within Biomarker-Guided Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer
Advanced Solid Tumor
Keywords: Cancer
Advanced Solid Tumor
Lead sponsor: Strata Oncology
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
name: Pfizer
name: Gilead Sciences
First posted: 2021-10-28
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: StrataPATH™ is a non-randomized, open-label trial designed to explore efficacy and safety of multiple FDA-approved and commercially available cancer therapies in new, biomarker-guided patient populations.

Detailed description: StrataPATH is a non-randomized, open-label trial designed to explore efficacy and safety of multiple FDA-approved and commercially available cancer therapies in new, biomarker-guided patient populations. Aiming to increase clinical benefit for patients, this study will leverage technology advancements, scientific literature, and Strata's real-world evidence to define novel, highly responsive pan-tumor molecular indications for FDA-approved therapies in both the advanced and micro-metastatic settings. Strata will rapidly identify participants who have efficacy signals for possible expansion into adaptive or randomized studies. Enrollment in each drug/biomarker cohort is competitive. Cohorts may be added, changed, or discontinued over the course of the study

Eligibility criteria: To be eligible to participate in this study, an individual must meet each of the criterion below and the criteria indicated in the selected biomarker/drug cohort appendix:

1. Male or female ≥18 years of age.
2. Pathologically confirmed solid tumor
3. Participants must be able to follow study visit schedule and willing to provide up to 20 mL of peripheral blood samples at the indicated time points
4. CGP results need to be from a test conducted in a CLIA approved laboratory and archival formalin-fixed, paraffin-embedded (FFPE) tumor tissue is required for confirmatory testing of non-Strata test results unless otherwise indicated within the cohort-specific protocol criteria.
5. Biomarker positive for the defined cohort
6. For individuals with non-primary, treated or stable brain metastases: No evidence of progression (defined as no radiographic evidence of progression) for at least 4 weeks prior to consent.
7. Adequate bone marrow, organ function \& laboratory parameters as determined by the treating physician unless otherwise indicated within the cohort-specific protocol criteria.
8. Adequate cardiac function: 1) Left ventricular ejection fraction (LVEF) ≥ 50% and 2) QTc interval ≤ 470 ms (females) or ≤ 450 ms (males) average preferred.

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Receiving another cancer treatment
2. Major surgery within 4 weeks prior to study entry
3. Has received a systemic cancer treatment within 3 weeks of first study dose
4. Individuals with a history of a second malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years or are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers that have been diagnosed and treated within the past 3 years are eligible: cervical/prostate carcinoma in situ, superficial bladder cancer, non-melanoma cancer of the skin. Patients with other cancers diagnosed within the past 3 years and felt to be at low risk of recurrence should be discussed with the study principal investigator to determine eligibility.
5. Participant has primary central nervous system tumor.
6. A woman of childbearing potential who has a positive urine pregnancy test (within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
7. Females who are pregnant or nursing or plan to become pregnant or anyone unwilling to use contraception for the duration of treatment.
8. Ongoing toxicity of CTCAE grade \>2, other than peripheral neuropathy, related to anticancer therapy that was completed within 4 weeks of consent.
9. Ongoing peripheral neuropathy of CTCAE grade \>3.
10. History of stroke including transient ischemic attack (TIA) or acute myocardial infarction within 6 months of consent.
11. Participant has a known history of human immunodeficiency virus (HIV), Hepatitis B or known active Hepatitis C virus infection.
12. Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder.
13. Any other clinically significant medical condition that, in the opinion of the treating physician, makes participation undesirable, including but not limited to ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness.

Primary outcomes:
measure: Overall response rate (ORR) defined as the percentage of participants with a best overall response of CR or PR based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as assessed by the investigator
timeFrame: Assessed throughout end of study, up to 5 years
Secondary outcomes:
measure: Duration of Response (DoR) defined as the time from first documentation of disease response (CR or PR) until first documentation of progressive disease
timeFrame: Assessed throughout end of study, up to 5 years
measure: Time to Treatment Discontinuation (TTD) defined as length of time from the date the participant initiates the systemic treatment to the date the participant discontinues treatment as compared to prior TTD from prior cancer treatment
timeFrame: Assessed throughout end of study, up to 5 years
measure: TTnT (Time to Next Treatment) defined as the length of time from the date the participant initiates study treatment to the date the participant initiates their next systemic treatment or death.
timeFrame: Assessed throughout end of study, up to 5 years
measure: ctDNA response: The proportion of participants with a <50% ratio of mean variant allele frequency (VAF) will be defined as ctDNA responders
timeFrame: 6 months
measure: Overall Survival (OS)
timeFrame: Assessed throughout end of study, up to 5 years
measure: Incidence of serious adverse events (SAEs)
timeFrame: Assessed throughout end of study, up to 5 years
measure: ctDNA Response Rate
timeFrame: Assessed throughout end of study, up to 5 years
Other outcomes:
measure: Explore the correlation between serial ctDNA levels over time and participant response to cancer therapy based on RECIST 1.1, as assessed by the investigator.
timeFrame: Assessed throughout end of study, up to 5 years
Locations:
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists - North
state: Florida
city: Tallahassee
country: United States
facility: Florida Cancer Specialists - Panhandle
state: Florida
city: Kettering
country: United States
facility: Kettering Health Network
state: Ohio
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Strata Oncology
name: Kat Kwiatkowski, PhD
role: STUDY_DIRECTOR
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