The purpose of this study is to determine the recommended Phase 2 dose (RP2D) of
JNJ-64041757 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 advanced (Stage IIIb) or
metastatic (Stage IV) NSCLC (adenocarcinoma).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02592967.
This is a first-in-human (FIH), Phase 1, open-label, multicenter and 2-part study in
participants with advanced (Stage IIIb) or metastatic (Stage IV) non-small cell lung
cancer (NSCLC) (adenocarcinoma). 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-64041757 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). Dose limiting toxicity (DLT) in part
1, antigen-specific T-cell response in part 2 and incidence of adverse events in both the
parts will be primarily evaluated.
Lead OrganizationJanssen Pharmaceuticals