First-in-Human, Phase 1/2 study, JNJ-63723283 in Advanced Cancers
Research type
Research Study
Full title
A First-in-Human, Open-label, Phase 1/2Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancers
IRAS ID
215891
Contact name
Frank de Beukelaar
Contact email
Sponsor organisation
Janssen Cilag International N
Eudract number
2016-002017-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 1 days
Research summary
The experimental drug used in this study is called JNJ-63723283. JNJ-63723283 is an antibody to the programmed cell death protein 1 (PD-1) and can block its function. PD-1 is known to put a break on the immune system. Blocking PD-1 with JNJ-63723283 is like taking the brake away. In test tubes using blood from volunteers, JNJ-63723283 increases the activity of the immune system. This study will test if this occurs in patients with cancer and if this increased immune activity helps control cancer. About 169 patients will take part in this worldwide study.
The purpose is to find out if JNJ-63723283 causes side effects (unexpected or unwanted reactions from taking a drug) and to see if JNJ-63723283 is useful for treating patients with advanced cancer. Another purpose is to find out how long JNJ-63723283 stays in and acts on the body and how the body responds to it. The study is made up of two parts. You will be entered into one of these parts.
Part 1: This part will test different doses of JNJ-63723283 starting with a dose considered to be safe based on animal models and tests conducted in test tubes with blood from volunteers. The dose can be increased if the patients treated with the starting dose do not have significant unwanted effects (also known as toxicities). In addition, different doses and different schedules of the study drug will be looked at in this part of the study.
Part 2: The dose will be based on the information collected during Part 1 of the study. All patients are required to send a tumour sample to participate in Part 2. This sample could be from a previous biopsy as long as it is not too old.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
16/NE/0344
Date of REC Opinion
11 Jan 2017
REC opinion
Further Information Favourable Opinion