Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available.
Conditions
Interventions
investigational material(s)
Generic name etc : DS-1123a
INN of investigational material :
Therapeutic category code : 42- Antineoplastic 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. -ECOG Performance Status (PS) 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, deep-vein thrombosis or clinically severe thromboembolic events, or clinically severe pulmonary disease (eg, interstitial pneumonia, pulmonary fibrosis, radiation pneumonia, drug induced pneumonia) -Severe or uncontrolled concomitant disease. -Clinically active brain metastases defined as symptomatic or requiring treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, tolerability, and pharmacokinetics -The safety of DS-1123a will be assessed by CTCAE. -The maximum tolerated dose of DS-1123a, and the recommended dose of DS-1123a for the following clinical studies will be estimated. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Incidence of anti-DS-1123a antibody -Exploratory assessment of DS-1123a-related biomarkers -Exploratory assessment of tumor response to DS-1123a -Tumor response will be assessed by RECIST | — |
Outcome results
None listed