StrataPATH™ (Precision Indications for Approved Therapies)
- Conditions
- CancerAdvanced Solid Tumor
- Interventions
- Registration Number
- NCT05097599
- Lead Sponsor
- Strata Oncology
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lorbrena® (lorlatinib) lorlatinib - Braftovi® (encorafenib) + Mektovi® (binimetinib) encorafenib + binimetinib - Talzenna® (talazoparib) talazoparib - Trodelvy® (sacituzumab govitecan-hziy) sacituzumab govitecan - Inlyta® (axitinib) axitinib - Enhertu® (fam-trastuzumab deruxtecan-nxki) Fam-Trastuzumab Deruxtecan-Nxki - Padcev® (enfortumab vedotin) enfortumab vedotin -
- Primary Outcome Measures
Name Time Method 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 Assessed throughout end of study, up to 5 years RECIST criteria will be used to assess the clinical activity of cancer treatments in participants with pre-specified biomarker profiles.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Assessed throughout end of study, up to 5 years Evaluate overall survival (OS) for participants who received a cancer treatment with pre-specified biomarker profiles
Incidence of serious adverse events (SAEs) Assessed throughout end of study, up to 5 years Monitor and summarize any unexpected safety events in participants who received a biomarker-guided cancer treatment
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 Assessed throughout end of study, up to 5 years TTD will be used to assess the duration of response of cancer treatments in participants with pre-specified biomarker profiles.
ctDNA response: The proportion of participants with a <50% ratio of mean variant allele frequency (VAF) will be defined as ctDNA responders 6 months 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.
Duration of Response (DoR) defined as the time from first documentation of disease response (CR or PR) until first documentation of progressive disease Assessed throughout end of study, up to 5 years DoR will be used to assess the duration of response of cancer treatments in participants with pre-specified biomarker profiles.
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. Assessed throughout end of study, up to 5 years TTnT will be used to assess the duration of response of cancer treatments in participants with pre-specified biomarker profiles.
ctDNA Response Rate Assessed throughout end of study, up to 5 years Evaluate ctDNA response rate at additional timepoints for participants who received cancer treatment with pre-specified biomarker profiles
Trial Locations
- Locations (4)
Kettering Health Network
🇺🇸Kettering, Ohio, United States
Florida Cancer Specialists - Panhandle
🇺🇸Tallahassee, Florida, United States
Florida Cancer Specialists - North
🇺🇸Saint Petersburg, Florida, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States