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.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
This arm of the Strata PATH trial will assess the clinical benefit of Lorbrena® (lorlatinib) in ALK and ROS1 gene fusion positive solid tumors, as detected by Strata testing, with the exception of NSCLC.
This arm of the Strata PATH trial will assess the clinical benefit of Braftovi® (encorafenib) + Mektovi® (binimetinib) in BRAF p.v600X mutated solid tumors, as detected by Strata testing, with the exception of melanoma and colorectal cancer.
This arm of the Strata PATH trial will assess the clinical benefit of Talzenna® (talazoparib) in patients with advanced solid tumors harboring deep deletions or deleterious mutations with LOH in BRCA1/2 and PALB2, as detected by Strata testing, excluding HER2 negative breast cancer.
Florida Cancer Specialists - North
St. Petersburg, Florida, United States
Florida Cancer Specialists - Panhandle
Tallahassee, Florida, United States
Kettering Health Network
Kettering, Ohio, United States
University of Wisconsin
Madison, Wisconsin, United States
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
RECIST criteria will be used to assess the clinical activity of cancer treatments in participants with pre-specified biomarker profiles.
Time frame: Assessed throughout end of study, up to 5 years
Duration of Response (DoR) defined as the time from first documentation of disease response (CR or PR) until first documentation of progressive disease
DoR will be used to assess the duration of response of cancer treatments in participants with pre-specified biomarker profiles.
Time frame: Assessed throughout end of study, up to 5 years
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
TTD will be used to assess the duration of response of cancer treatments in participants with pre-specified biomarker profiles.
Time frame: Assessed throughout end of study, up to 5 years
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.
TTnT will be used to assess the duration of response of cancer treatments in participants with pre-specified biomarker profiles.
Time frame: Assessed throughout end of study, up to 5 years
ctDNA response: The proportion of participants with a <50% ratio of mean variant allele frequency (VAF) will be defined as ctDNA responders
Molecular response calculated as a ratio of mean VAF on treatment at 6 months compared to baseline VAF will be used to assess the clinical activity of cancer treatments in participants with pre-specified biomarker profiles.
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This arm of the Strata PATH trial will assess the clinical benefit of Trodelvy® (sacituzumab govitecan) in patients with advanced solid tumors and are Trop2 Treatment Response Score High (Trop2 TRS-H), as detected by Strata testing, excluding triple negative breast cancer, hormone receptor positive/ human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer, metastatic urothelial cancer, non-small cell lung (NSCLC) cancer, small cell lung cancer (SCLC), head and neck cancer, colorectal cancer (CRC), and endometrial cancer.
This arm of the Strata PATH trial will assess the clinical benefit of Inlyta® (axitinib) in patients with advanced solid tumors and are Angiogensis Inhibitor Treatment Response Score High (Angio TRS-H), as detected by Strata testing, excluding renal cell carcinoma, alveolar soft part sarcoma, and solitary fibrous tumors.
This arm of the Strata PATH trial will assess the clinical benefit of Enhertu ® in patients with advanced solid tumors with Her2 overexpression
This arm of the Strata PATH trial will assess the clinical benefit of Padcev® in patients with advanced solid tumors with nectin-4 overexpression
Time frame: 6 months
Overall Survival (OS)
Evaluate overall survival (OS) for participants who received a cancer treatment with pre-specified biomarker profiles
Time frame: Assessed throughout end of study, up to 5 years
Incidence of serious adverse events (SAEs)
Monitor and summarize any unexpected safety events in participants who received a biomarker-guided cancer treatment
Time frame: Assessed throughout end of study, up to 5 years
ctDNA Response Rate
Evaluate ctDNA response rate at additional timepoints for participants who received cancer treatment with pre-specified biomarker profiles
Time frame: Assessed throughout end of study, up to 5 years