Kanjinti - comparison with Herceptin in combination with Perjeta v1
Research type
Research Study
Full title
A Randomized, Double-Blind, Single-Dose, 2-Arm, Parallel Group Study to Determine the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of ABP 980 (Kanjinti®; Trastuzumab) plus Pertuzumab (Perjeta®) Compared with Trastuzumab (Herceptin®) Plus Pertuzumab (Perjeta®) Combined in a Single Infusion Bag in Healthy Male Subjects. (HMR code: 18-014)
IRAS ID
252002
Contact name
Adeep Puri
Contact email
Sponsor organisation
Amgen Inc
Eudract number
2018-002903-33
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
Kanjinti® (also called ABP 980; the study medicine) is similar to a medicine called Herceptin®, which is already authorised in the UK. Kanjinti® and Herceptin® contain the active substance trastuzumab, which is a ‘monoclonal antibody’ that attaches to a specific protein called HER2 (human epidermal growth factor receptor 2). Kanjinti® is approved in the UK as a ‘biosimilar’ medicine to Herceptin®, which means it is similar in quality, safety, and efficacy to Herceptin®.\n\nKanjinti® and Herceptin® can be prescribed by doctors to treat certain types of cancer, such as some breast and stomach cancers, which produce high amounts of HER2. HER2 stimulates the growth of some cancer cells. Herceptin® and Kanjinti® work by binding to HER2 to stop the growth of those cancer cells and cause them to die.\n\nPerjeta®, another monoclonal antibody that attaches to HER2, is used in combination with Herceptin® to treat cancer that has spread to other parts of the body. Perjeta® works in a similar way to Herceptin®. \n\nDoctors might want to prescribe Kanjinti® in combination with Perjeta®, as they do with Herceptin®, given by subsequent IV infusions. But, they can’t do that unless they know the blood levels and side effects of Kanjinti® and Herceptin® are still similar, when taken in combination with Perjeta® as a co-infusion. \n\nIn this study, we’ll give 36 healthy men, aged 18–45 years, a single dose of either Kanjinti® combined with Perjeta® or Herceptin® combined with Perjeta® in the same infusion bag, given by infusion (slow injection) into a vein.\n\nParticipants will take up to 10 weeks to finish the study. They’ll stay on the ward for 2 nights in a row, and they’ll make 11 outpatient visits.\n\nA pharmaceutical company (Amgen Inc.) is funding the study.\n\nThe study will take place at 1 centre in London.
REC name
Wales REC 1
REC reference
18/WA/0274
Date of REC Opinion
1 Oct 2018
REC opinion
Further Information Favourable Opinion