Advanced solid malignant tumors refractory to standard treatment or for which no standard treatment is available.
Conditions
Interventions
investigational material(s)
Generic name etc : DS-5573a
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material
Sponsors
DAIICHISANKYO Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available. -Eastern Cooperative Oncology Group Performance Status of 0 or 1
Exclusion criteria
Exclusion criteria: -Have any of the following concomitant disease or had the history of having following disease within 6 months before enrollment: Cardiac failure (NYHA >= ClassIII), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary-artery/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thromboembolism, uncontrolled deep-vein thrombosis or clinically severe thromboembolic event, autoimmune disorders requiring treatment. -Severe or uncontrolled concomitant disease. -Clinically active brain metastases defined as symptomatic or requiring treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and pharmacokinetics -The safety of DS-5573a will be assessed by CTCAE. -The maximum tolerated dose of DS-5573a, and the recommended dose of DS-5573a for the following clinical studies will be estimated. -Pharmacokinetics of DS-5573a will be evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Incidence of human anti-human antibodies (HAHA) against DS-5573a. -Assessment of tumor response to DS-5573a. -Exploratory assessment of DS-5573a-related biomarkers. Tumor response will be assessed by RECIST. | — |
Outcome results
None listed