Abstract CT059: StrataPATHTM: a multicohort, non-randomized, open-label phase 2 trial to explore efficacy and safety of FDA-approved cancer therapies in novel biomarker-guided patient population
Authors: Kwiatkowski Kat , Lamb Laura E. , Tomlins Scott A. , Johnson D. Brian , Hovelson Daniel H. , Khazanov Nickolay , Bulen Benjamin J. , Reeder Travis , Rhodes Daniel R. 
Published: April 2023

Purpose: The Strata Precision Indications for Approved Therapies (Strata PATH; NCT05097599) trial is a non-randomized open-label, prospective pan-tumor therapeutic trial designed to evaluate the efficacy and safety of multiple FDA-approved cancer therapies in new, biomarker-guided patient populations. Enrollment into a cohort of this basket trial is based on novel biomarkers including DNA, quantitative RNA expression and novel multivariate algorithms that account for both tumor and tumor microenvironment variables hypothesized to predict improved therapeutic response. The therapeutic classes evaluated in Strata PATH include targeted therapies, antibody-drug conjugates, immunotherapies, and angiogenesis inhibitors.

Trial Design: Key eligibility criteria are pathologically confirmed solid tumor. Patients are assigned to treatment by tumor type and biomarker status (Table). All patients will be treated until disease progression, unacceptable toxicity, patient/physician decision to withdraw, or 3 years of treatment from the date of consent. Primary Outcome measure includes overall response rate (ORR) as assessed by the investigator according to RECIST version 1.1. Secondary outcome measures include ctDNA response, Duration of Response (DoR), Time to Treatment Discontinuation (TTD), Time to Next Treatment (TTNT), Overall Survival (OS), safety, and ctDNA Response Rate. Enrollment is ongoing with 35 participants per cohort for up to 20 cohorts (700 participants total).

Summary: Strata PATH provides the next important step forward in precision medicine, guiding clinical trial and therapy selection by expanding biomarker testing to quantifiable RNA expression and multivariant algorithm based molecular testing.

Table. Strata PATH Biomarker-guided cohorts for expanded treatment of already FDA-approved drugs outside approved tumor indications Biomarker Molecular Test Therapy ALK ROS1 DNA Lorlatinib BRAF DNA Binimetinib + Encorafenib BRCA, PALB2 DNA Talazoparib HER2 overexpression RNA fam-Trastuzumab deruxtecan-nxki Trop2 targeting algorithm Multivariate Algorithm Sacituzumab govitecan-hziy Immunotherapy Response Score (IRS) Multivariate Algorithm PD-1 inhibitor Angiogenesis Response Score (ARS) Multivariate Algorithm Axitinib

Citation Format: Kat Kwiatkowski, Laura E. Lamb, Scott A. Tomlins, D. Brian Johnson, Daniel H. Hovelson, Nickolay Khazanov, Benjamin J. Bulen, Travis Reeder, Daniel R. Rhodes. StrataPATHTM: a multicohort, non-randomized, open-label phase 2 trial to explore efficacy and safety of FDA-approved cancer therapies in novel biomarker-guided patient population [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 2 (Clinical Trials and Late-Breaking Research); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(8_Suppl):Abstract nr CT059.