Solid Cancer 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 metastatic solid cancers which are not curable with, or not eligible for standard treatment(s) ECOG performance status: 0-1
Exclusion criteria
Exclusion criteria: Patients with a clinically active brain metastasis, or who need drugs like steroid to control edemas Patients with diarrhea (grade 2) Inflammatory bowel disease, or partial bowel obstruction Patients with pleural effusion or ascites effusion that requires drainage Patients with history of myocardial infarction or cerebral infarction within 6 months Patients with any severe or uncontrolled intercurent diseases
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 |
|---|---|
| Anti-CS-1008 antibodies Determination of the recommended Phase 2 dose Preliminary anti-tumor effect of CS-1008 Preliminary biomarker study of CS-1008 To characterize the immunogenicity of CS-1008 by monitoring for anti-CS-1008 antibodies To study potential biomarker of CS-1008 activity according to the protocol To evaluate anti-tumor effect according to RECIST | — |
Outcome results
None listed