DS-8201a In HER2-Positive Gastric/GEJ cancer on or After Trastuzumab
Research type
Research Study
Full title
A Phase 2, open-label, single-arm trial of trastuzumab deruxtecan (DS-8201a) in HER2-positive, unresectable or metastatic gastric or gastro-esophageal junction (GEJ) adenocarcinoma subjects who have progressed on or after a trastuzumab-containing regimen
IRAS ID
265510
Contact name
Anna Hammerbacher
Contact email
Sponsor organisation
Daiichi Sankyo Inc.
Eudract number
2019-001512-34
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 3 days
Research summary
Summary of Research
Gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer-related deaths. Some cases are Human Epidermal Growth Factor Receptor 2 (HER2) positive. The standard first line treatment of HER2- positive gastric cancer involves a combination therapy of chemotherapy and the antibody, trastuzumab (a type of protein). While this has greatly improved the overall survival of participants, there is no established second-line HER2- targeting drug for gastric cancer after treatment with a trastuzumab-containing regimen.
Daiichi Sankyo Inc. is therefore conducting this study of an investigational medicine called Trastuzumab Deruxtecan (DS-8201a). Participants with HER2-positive gastric or gastroesophageal junction (GEJ) cancer who have progressed on or after a Trastuzumab containing treatment regimen will be enrolled. DS8201a is an antibody drug conjugate, which means it is made up of two parts; a drug and an antibody. The antibody part binds to cancer cells that have the HER2 receptor and delivers the drug part into the cancer cell. This prevents HER2 activity and leads to the death of cancerous cells.
Men and women ≥18 years of age with HER2-positive gastric or GEJ cancer that has either spread and/or cannot completely be removed by surgery are eligible. Approximately 72 participants, enrolled at approximately 25 to 30 study sites including but not limited to North America, Australia, Israel, and the European Union (EU) will be participating. Other countries may be considered.
Enrolment is expected to occur over approximately 12-18 months. Most participants will receive between 10 and 20 cycles of DS-8201a via infusion. Participants will begin at a starting dose of 6.4 mg/kg based on their body weight.
Treatment and follow-up are projected to be continued for at least 12 months after the last subject is enrolled. The anticipated duration of the study is at least 24 to 30 months.Summary of Results
Plain language summary is currently being created based off the final results and will be submitted to clinicaltrials.gov public registry by 13Feb2025 (1 year from the Last Patient Last Visit).
REC name
London - Central Research Ethics Committee
REC reference
19/LO/1309
Date of REC Opinion
11 Oct 2019
REC opinion
Further Information Favourable Opinion