solid malignancies
Conditions
Sponsors
Aichi Cancer Center Hospital
DAIICHI SANKYO Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Informed consent for participation in the study is obtained at the discretion of the patient. 2.The patient is 20 years of age or older on the date of informed consent. 3.Histologically or cytologically confirmed an unresectable advanced or recurrent solid malignancy who are refractory or intolerant to stanard therapy. 4.HER2 genomic amplified is detected by analysis of blood sample using Guardant360: 5.The disease is measurable based on the Response Evaluation Criteria in Solid Tumours (RECIST) guidelines version 1.1. 6.Adequate organ function 7.Males and women of childbearing potential who are negative in a urine pregnancy test agree to use contraception from obtaining informed consent through 4.5months after the final administration of DS-8201a.
Exclusion criteria
Exclusion criteria: [Principal Analysis Cohort (Enrollment Completed)] 1.Has a history of prior treatment with antibody-drug conjugate (ADC) consists of DS-8201a or an exatecan derivative. 2.Patients diagnosed with gastric cancer, breast cancer, colorectal cancer, lung cancer, biliary tract cancer, uterine carcinosarcoma, or osteosarcoma, in whom high HER2 expression has been confirmed by tumor tissue evaluation. 3.Has spinal cord compression or clinically active central nervous system metastases. 4.Patients with uncontrolled acute systemic infection or diabetes mellitus. 5.Medical history of myocardial infarction within 6 months before enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), troponin levels consistent with myocardial infarction as defined according to the manufacturer 28 days prior to enrollment. 6.Have a history of other malignancies within 3 years prior to enrollment. 7.Has HIV infection. Patients who are HBs antigen positive or HBs antibody or HBc antibody positive and HBV-DNA positive. Or have active hepatitis C. 8.Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. 9.having a clinically relevant corneal disease. [Expansion cohort] 1. Has a history of prior treatment with antibody-drug conjugate (ADC) consists of DS-8201a or an exatecan derivative. 2. The patient is considered eligible for treatment with Enhertu(R). 3. with lesions that compress the spinal cord. 4.Patients with uncontrolled acute systemic infection. 5.Medical history of myocardial infarction within 6 months before enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), troponin levels consistent with myocardial infarction as defined according to the manufacturer 28 days prior to enrollment. 6.Have a history of other malignancies within 3 years prior to enrollment. 7. HIV infection and poorly controlled. Active or poorly controlled hepatitis B or active hepatitis C. 8.Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. 9.having a clinically relevant corneal disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy objective response rate(ORR) assessed by investigators | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Progression-free survival: PFS Duration of response: DoR Time to treatment failure: TTF Disease control rate: DCR Overall survival: OS ORR by central assessment (Principal Analysis Cohort only) Changes of sum of tumor diameter AE | — |
Countries
Japan
Contacts
Public Contactclinical trial coordinating committee
National Cancer Center Hospital East
Outcome results
None listed