Advanced solid tumors not curable with, or not eligible for standard treatment(s)
Conditions
Sponsors
DAIICHISANKYO Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically or cytologically diagnosed advanced solid tumors as listed below which are not curable with, or not eligible for standard treatment(s): Lung, breast, colorectal, prostate, ovarian, cervical, endometrial, gastric, pancreatic, bladder, head and neck, hepatocellular, esophageal, malignant melanoma, or sarcoma -ECOG performance status: 0-1
Exclusion criteria
Exclusion criteria: -History of any of the following diseases within 6 months prior to study enrollment or comorbid medical conditions: heart failure, myocardial infarction, cerebral infarction, active angina, arrhythmia requiring medication, coronary/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thrombosis, deep vein thrombosis, other clinically significant thromboembolic events, or clinically significant pulmonary disease (e.g., COPD or asthma) -Patients with any severe or uncontrolled comorbid medical conditions in spite of medications -Has brain metastasis with clinical symptoms or requiring treatment -Has history of bleeding diathesis (e.g., hemoptysis) -Has history of serious drug hypersensitivity such as anaphylactoid reaction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Pharmacokinetics -To evaluate the safety profile according to CTCAE -To evaluate the pharmacokinetics according to the protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| -Incidence of anti-U3-1287 antibody -Determination of the recommended dose for subsequent clinical studies -Preliminary assessment of anti-tumor activity of U3-1287 -Exploratory study on U3-1287-related biomarkers -To evaluate anti-tumor activity in accordance with RECIST -To study potential U3-1287-related biomarkers according to the protocol | — |
Outcome results
None listed