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
Inclusion Criteria:
- 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
- Has a left ventricular ejection fraction (LVEF) ≥ 50%
- Has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1
EXCLUSION CRITERIA
Exclusion Criteria:
- Has a contraindication for receiving ritonavir or itraconazole according to the prescribing information
- Has a medical history of myocardial infarction within 6 months before enrollment or symptomatic congestive heart failure
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
Contition
Neoplasm Metastasis
Age (in years)
20+
Phase
Phase 1
Participants needed
40
Est. Completion Date
Mar 31, 2024
Treatment type
Interventional
Sponsor
Daiichi Sankyo, Inc.
ClinicalTrials.gov identifier
NCT03383692
Study number
DS8201-A-A104
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