The purpose of the study is to identify the maximum tolerated dose (MTD) of JNJ-64619178
in participants with relapsed/refractory B cell non-Hodgkin lymphoma (NHL) or advanced
solid tumors and also to identify the recommended Phase 2 dose(s) (RP2Ds) of JNJ-64619178
for NHL and advanced solid tumors (Part 1) and to confirm the tolerability of
JNJ-64619178 in participants with lower risk myelodysplastic syndromes (MDS) (Part 2).
Additional locations may be listed on ClinicalTrials.gov for NCT03573310.
See trial information on ClinicalTrials.gov for a list of participating sites.
The study is designed to determine the maximum tolerated dose (MTD) of JNJ-64619178, and
to select a dose(s) and regimen(s) that may be used in future clinical development. Study
evaluations will include safety, pharmacokinetics, biomarkers and efficacy evaluations
(Disease Assessments). Adverse events will be evaluated throughout the study. The study
is divided into 4 periods: a screening phase, a pharmacokinetic run-in phase, a treatment
phase, and a post treatment follow-up phase. An end-of-treatment visit will be completed
less than or equal (<=) 30 days (+7 days) after the last dose of study drug or prior to
the start of a new anticancer therapy, whichever comes first.
Lead OrganizationJanssen Pharmaceuticals
