This phase 2 trial is examining the effectiveness and safety of DS-8201a in the treatment of advanced HER2 positive colorectal cancer. The main outcome to be measured is the tumor response to the treatment and side effects.
The standard treatment to advanced colorectal cancers is surgery, chemotherapy and radiation therapy. However, these treatments are only of limited effectiveness in advanced cases. Patients with colorectal cancer positive for the HER2 mutations (permanent change) have a more aggressive kind of tumor. The HER2 mutation increases tumor growth and spread rate. Therefore, new therapies such as DS-8201a are often added to the treatment to improve effectiveness. DS-8201a is an immune therapy drug that stops the HER2 mutation from increasing tumor growth. It is not clear how this agent could affect the treatment of patients with advanced colorectal cancer.
This trial is assessing the safety and effectiveness of DS-8201a in patients with HER2-positive colorectal cancer. The main outcome will be tumor response.
Who are they looking for?
This trial is recruiting 90 patients with advanced, not suitable for surgery or recurrent colorectal cancer. Patients must have had at least 2 prior treatments.
Patients must not have any heart or lung disease (including a heart attack in the previous 6 months) or any brain metastasis (tumors).
How will it work
Patients will be divided according to their HER2 mutation status. All patients will then receive DS-8201a once every 3 weeks. The main outcomes will be response to treatment and survival rated. Patients will be followed up for up to 18 months.