The purpose of this study is to find and evaluate the recommended Phase 2 dose (RP2D) of
JNJ-64041809, a live attenuated double deleted (LADD) Listeria monocytogenes (bacteria in
which two virulence genes, which encode molecules that help cause disease, have been
removed) when administered intravenously to participants with metastatic
castration-resistant prostate cancer (mCRPC).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02625857.
This is a first-in-human (FIH), Phase 1, open-label, multicenter and 2-part study. The
Part 1 of study will be Dose Escalation phase to determine the recommended Phase 2 dose
(RP2D) based on safety and pharmacodynamic assessments and Part 2 will be Dose Expansion
Phase to evaluate 2 expansion cohorts (Cohort 2A and 2B) after the RP2D for JNJ-64041809
is determined in Part 1. The study will consist of a Screening Period (from signing of
informed consent until immediately before the first dose), an open-label Treatment Period
(from the first dose of study drug until the End-of-Treatment Visit); and a Post
treatment Follow-up Period (after the End-of Treatment Visit until study
discontinuation). Participants will be primarily evaluated for RP2D. Participants safety
will be evaluated throughout the study.
Lead OrganizationJanssen Pharmaceuticals
