An Open-label, First-in-Human, Phase 1 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-61610588, a Fully Human IgG1 Kappa Anti-VISTA (V-domain Ig Suppressor of T-cell Activation) Monoclonal Antibody, in Subjects with Advanced Cancer

Protocol: 
AAAQ6109
Phase: 
I

An Open-label, First-in-Human, Phase 1 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-61610588, a Fully Human IgG1 Kappa Anti-VISTA (V-domain Ig Suppressor of T-cell Activation) Monoclonal Antibody, in Subjects with Advanced Cancer

The purpose of this study is to see if JNJ-61610588 is safe and useful for treating patients with cancer. Another purpose is to find out how long JNJ-61610588 stays in and acts on your body and how your body responds to it. The first part will find the dose of JNJ-61610588 that would be best to give to cancer patients. (A dose is a measured amount of drug taken at one time.) The safety and side effects of different doses of JNJ-61610588 will be explored . The second part will look at how cancer responds to a safe dose of JNJ-61610588. Only patients with non-small cell lung cancer can participate in this part of the study. The third and fourth parts will see if a safe dose of JNJ-61610588 is useful for treating patients with cancer. Part 3 is for patients with non-small cell lung cancer. Part 4 is for patients with small cell lung cancer, head and neck cancer, colorectal cancer, pancreatic cancer, and cervical cancer.

Are you Eligible? (Inclusion Criteria)

1. Subject must be >=18 years of age
2. Measurable disease according to RECIST (v1.1), except in Part 1 where subjects
with evaluable disease are also eligible.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. A woman of childbearing potential must have a negative serum (?-human
chorionic gonadotropin [?-hCG]) or urine pregnancy test prior to the first dose
of study drug.

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States