Strata Oncology, Inc., a next-generation precision oncology company enabling smarter and earlier cancer treatment, today announced enrollment of the first patient in the Strata Precision Indications for Approved THerapies (Strata PATH^TM) trial, a prospective pan-tumor therapeutic trial designed to evaluate the efficacy and safety of multiple FDA-approved cancer therapies in new, biomarker-guided patient populations. “The Strata PATH trial is a crucial step in our mission to accelerate the impact of precision medicine for patients with cancer, in both the early- and late-stage settings,” said Dan Rhodes, PhD, co-founder and Chief Executive Officer, Strata Oncology. “There is no time to spare when it comes to getting patients their best possible therapies, so we have taken the initiative to sponsor this trial to prospectively test novel biomarker-guided treatment hypotheses that we believe may result in new, highly-responsive pan-tumor molecular indications for FDA-approved therapies.”

“We are pleased to be working with Strata Oncology on the innovative Strata PATH trial,” said Priya Jain, MD, Medical Oncologist and Principal Investigator with Kettering Health, the site of the first patient enrollment. “We are committed to bringing the latest in medical technology and advanced care to the community of patients we serve, and we are proud to be able to offer our patients the chance to enroll in this cutting-edge clinical trial.”

Strata used its clinical molecular database, developed through a previous clinical study known as the Strata Trial^TM, to devise the hypotheses being tested in Strata PATH. The database includes both DNA mutation profiles and quantitative RNA expression data from tens of thousands of patients coupled with detailed treatment history and outcomes data. Enrollment for multiple arms in Stata PATH is based on novel quantitative RNA and multivariate algorithms the company developed.

“Due to the rapid clinical development of multiple therapies against expression-based targets, comprehensive genomic profiling alone is often insufficient to identify a patient’s best treatment,” said Rhodes. “Strata Oncology is making cancer treatment smarter by developing quantitative RNA and multivariate algorithms that can guide the use of a range of therapeutic classes, including antibody-drug conjugates, immunotherapies and angiogenesis inhibitors.” Strata PATH will enroll patients with advanced cancer, as well as patients with early-stage cancer who have evidence of micrometastatic disease after initial treatment. The company expects that many of the patients with micrometastatic disease will be identified through the Strata Sentinel^TM trial, a 100,000-patient, prospective, observational, pan-solid tumor study of Strata Oncology’s highly sensitive, tumor-informed circulating tumor DNA (ctDNA)-based MRD test. 

All therapies being evaluated in Strata PATH are FDA-approved in oncology with demonstrated safety profiles in the advanced setting. Each drug will be administered according to the FDA-approved dosing regimen listed in the approved product labeling.