solid tumors
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - ECOG PS of 0 or 1 - Life expectancy for at least 12 weeks - Histologically or cytologically confirmed solid tumor - Failure to respond to, or not suitable for, standard therapy, or progression/recurrence of cancer without established standard therapy - Patients with imaging lesions evaluable by RECIST v1.1
Exclusion criteria
Exclusion criteria: - Pregnant or lactating patients - Patients with symptomatic or treated central nervous system tumor or metastases to the central nervous system - Patients with spinal cord compression lesions - Patients with significant cardiovascular disease - Patients with significant liver disease - HIV, active HBV, active HCV positive - Dementia or altered mental status that would preclude obtaining informed consent - Pleural effusion, pericardial effusion, or ascites requiring drainage. - Patients with significant autoimmune disease or immunodeficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety, phamacokinetics, other Dose limiting toxicity(DLT) NCI CTCAE v5.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy RECIST v1.1 | — |
Contacts
Chugai Pharmaceutical Co., Ltd.