For Healthcare Professionals

Study of DS-8201a for Participants With Advanced Solid Malignant Tumors


About the study

HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells. This study will test an experimental drug called DS-8201a that has not been approved by the health authorities yet. DS-8201a will be tested for safety in patients with advanced solid malignant tumors that test positive for HER2. It also will test how DS-8201a moves within the body (pharmacokinetics).

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. Has a pathologically documented unresectable or metastatic solid malignant tumor, with HER2 expression [immunohistochemistry (IHC) 3+, 2+, or 1+ and/or in situ hybridization (ISH) +], Next Generation Sequencing, or other analysis techniques as appropriate] that is refractory to or intolerable with at least one prior systemic chemotherapy regimen, or for which no standard treatment is available
  2. Has a left ventricular ejection fraction (LVEF) ≥ 50%
  3. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1


Exclusion Criteria:

  1. Has a contraindication for receiving ritonavir or itraconazole according to the prescribing information
  2. Has a medical history of myocardial infarction within 6 months before enrollment or symptomatic congestive heart failure

pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Neoplasm Metastasis

Age (in years)



Phase 1

Participants needed


Est. Completion Date

Mar 31, 2024

Treatment type



Daiichi Sankyo, Inc. identifier


Study number


Understanding Clinical Trials

Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?


Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.