A Phase I Study of DS-8201A in Patients with Advanced Solid Tumors

Full Title

DS8201-A-J101: Phase 1, Two-Part, Multicenter, Non-Randomized, Open-Label, Multiple Dose First-in-Human Study of DS-8201a, in Subjects with Advanced Solid Malignant Tumors


DS-8201A is an investigational drug that targets a protein on some cancer cells called HER2. It consists of an antibody which attaches to the HER2 receptor, and a chemotherapy drug that is then released to kill the cancer cell.

In this study, researchers are evaluating the best dose and preliminary effectiveness of DS-8201A in patients with advanced HER2-positive breast cancer, advanced HER2-positive stomach and gastroesophageal junction cancers (the junction between the stomach and esophagus), other advanced HER2-positive solid tumors, and advanced breast cancers that contain low levels of HER2. DS-8201A is given intravenously (by vein).


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced breast cancer, advanced HER2-positive stomach or gastroesophageal junction cancer, or another advanced HER2-positive solid tumor that cannot be treated successfully with standard treatments.
  • Patients must recover from the serious side effects of prior therapies before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Shanu Modi at 646-888-4564.