Abstract
2554Background: RX-5902 is a novel compound that targets phosphorylated p68 RNA helicase (also known as DDX5), a member of the DEAD box family of RNA helicases. Phosphorylated p68 may play a vital role in cell proliferation and tumor/cancer progression. As a single agent, RX-5902 inhibits tumor growth, alters cell migration and enhances survival in a variety of in vivo animal xenograft tumor models (e.g., breast, ovarian, renal, pancreatic). We report the data from the first clinical study of RX-5902 as a single agent to treat solid tumors. Methods: This is a Phase 1 study (NCT02003092) designed to evaluate safety, tolerability and pharmacokinetics following increasing doses of RX-5902 at varying schedules. Primary objectives include safety, tolerability and dose limiting toxicities to identify the maximum tolerated dose and a recommended phase 2 dose and schedule (RP2D). Secondary objectives were pharmacokinetics (PK) and antitumor activity (RECIST v1.1). Eligible subjects (aged ≥ 18 years) with relapsed...
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