Phase 1 Study of EGFR and cMet Ab,JNJ-61186372, in advanced NSCLC
Research type
Research Study
Full title
A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Subjects with Advanced Non-Small Cell Lung Cancer
IRAS ID
255361
Contact name
Nick Hodges
Contact email
Sponsor organisation
Janssen Cilag International NV
Eudract number
2018-003908-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 15 days
Research summary
The experimental drug used in this study is JNJ-61186372, an antibody to 2 receptors; EGFR and cMet, showed in lung cancer. These are known to increase survival and proliferation of cells, including cancer cells. By blocking this action, it is more difficult for cancer cells to proliferate and survive. 1st line standard of care is by TKI therapy, which targets EGFR. Over time cancer cells become resistant to this treatment and no longer works. Often this happens due to new mutations in the EGFR gene (which results in a change in shape of the EGFR receptor so the drug can no longer bind) or through a process known as MET amplification (which means the cancer cells are being stimulated to grow through activation of the MET pathway). JNJ-61186372 is designed to bind to both EGFR (the normal and mutated types) and cMet, blocking their function. In test tubes using blood from volunteers and in mice, JNJ-61186372 blocks the EGFR and cMet. By doing so, tumour growth was halted. This study will test if this occurs in patients with advanced, metastatic non-small cell lung cancer and if patients with mutated EGFR who have failed standard of care treatment may benefit. About 180 patients will take part in this worldwide study. The purpose of this study is to see if JNJ-61186372 is safe and useful for treating patients. The amount of JNJ-61186372 that is in the blood after dosing will also be studied. There are 2 parts to this study with EGFR mutation positive lung cancer. Part 1 is testing different doses starting with a dose considered to be safe based on animals and tests conducted in blood from volunteers. Part 2 consists of 4 cohorts:A,B,C and D.The UK will only participate in Part 2.In part 2, JNJ-61186372 will be given to a dose decided in part 1, to see if the drug is safe and can be of clinical benefit.
REC name
North West - Haydock Research Ethics Committee
REC reference
18/NW/0846
Date of REC Opinion
31 Jan 2019
REC opinion
Further Information Favourable Opinion