HER2-expressing recurrent and/or metastatic salivary gland carcinoma HER2-expressing, salivary gland carcinoma, recurrent and/or metastatic
Conditions
Interventions
DS-8201a 100 mg for injection is infused intravenously every 21 days (19-23 days) at a dose of 5.4 mg / kg based on the body weight of the subject.
intravenously infusion, per body weight
Sponsors
Hirotoshi Akita
AKITA Hirotoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 20 years and over at the time of written informed consent Histologically confirmed recurrent and or metastatic salivary gland carcinoma No indication for curative treatment Tumor tissue or undryed glass specimen is available IHC 3 plus IHC 2 plus IHC 1 plus and or ISH plus Patient with measurable lesion by RECIST version 1.1 ECOG performance status of 0 or 1 Adequate organ function
Exclusion criteria
Exclusion criteria: History and complication of myocardial infarction or congestive heart failure Prolonged QT interval Complication of Interstitial lung disease Active central nervous system metastasis Other active malignancies Prior treatment with ADC of Exatecan derivative Topoisomerase I inhibitor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate by the Independent Central Image Committee | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Best percent change in sum of diameter for tumor Disease control rate Progression free survival Overall survival Objective response rate by Principal Investigators Safety | — |
Contacts
Public ContactYudai Watanabe
Hokkaido University Hospital
Outcome results
None listed