Daiichi Sankyo DS8201-A-U201 (DS-8201a)
Research type
Research Study
Full title
A Phase 2, Multicenter, Open-Label Study of DS-8201a, an Anti-HER2-Antibody Drug Conjugate (ADC) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Who are Resistant or Refractory to T-DM1.
IRAS ID
235575
Contact name
Peter Schmid
Contact email
Sponsor organisation
Daiichi Sankyo
Eudract number
2016-004986-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 30 days
Research summary
Breast cancer is the most common cancer in the world affecting women. In approximately 20% of breast cancers too many copies of a protein (building blocks of body tissue) called the human epidermal growth factor receptor 2 are made. This receptor communicates growth signals to the cancer cell, and may play a role in cancer development. There is currently no treatment targeting the human epidermal growth factor receptor 2 that has shown to be effective in participants who do not respond to trastuzumab emtansine (T-DM1) or become resistant to T-DM1.
The study is a multicentre, phase 2, open-label study of DS8201a (the study drug) in approximately 90 study sites across the world and plans to enrol approximately 230 men or women. The study is being carried out to see if the study drug is safe and effective in treating a certain type of breast cancer called human epidermal growth factor receptor 2-positive breast cancer that has spread and/or cannot be completely removed by surgery and has been previously treated with T-DM1.
The study is in two parts: Part 1 and Part 2. Part 1 is made up of pharmacokinetic (PK – what the body does to the drug) stage and a dose finding stage. The results from Part 1 of the study will determine the dose to be given in Part 2. Part 2 is made up of Part 2a and Part 2b. Part 2a will be for participants who are resistant to T-DM1 and Part 2b will enrol participants who stopped treatment with T-DM1 for reasons other than resistance.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
17/SC/0609
Date of REC Opinion
3 Jan 2018
REC opinion
Further Information Favourable Opinion