The primary purpose of the study is to determine the recommended Phase 2 dose (RP2D) and
schedule of JNJ-64457107 when administered intravenously (IV) to participants with
advanced stage solid tumors in Part 1 and to further characterize the safety of
JNJ-64457107 when administered IV to participants with non-small cell lung cancer
(NSCLC), pancreatic cancer and cutaneous melanoma in Part 2.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02829099.
This study has 2 parts: Dose Escalation (part 1) and Dose Expansion (part 2) which are
conducted in 3 phases: Screening Phase (up to 28 days prior to first dose of study drug
and includes procedures like electrocardiogram [ECG], serum pregnancy test), Treatment
phase (continues until the completion of the End-of-Treatment Visit [30 days after last
dose of study drug]) and Post-treatment follow-up phase (continues until the participant
has died, is lost to follow-up, or has withdrawn consent or the study ends). In
follow-up, participants will continue to be monitored for survival status and subsequent
cancer-related therapies until the end of study. Additional bio-markers will be assessed,
in an optional sub-study, to define the impact of JNJ-64457107 on innate and adaptive
immune responses in tumors. Safety will be monitored throughout the study by Safety
Evaluation Team (SET).
Lead OrganizationJanssen Pharmaceuticals
