Unresectable advanced or recurrent solid tumors
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants with histologically or cytologically confirmed unresectable advanced or recurrent solid tumors. 2. Participants who are refractory or intolerant to standard therapy. 3. Participants with Eastern Cooperative Oncology Group Performance Status 0 or 1. 4. Participants with tumor tissue samples available for biomarker testing.
Exclusion criteria
Exclusion criteria: 1. Participants with a history or presence of severe hypersensitivity to any other antibody agents. 2. Participants with pericardial fluid, pleural effusion or ascites requiring treatment 3. Participants with uncontrolled tumor-related pain 4. Participants with severe peritoneal dissemination. 5. Participants with multiple primary cancers. 6. Participants with a history or presence of ILD or pulmonary fibrosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability, safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy, Pharmacokinetics (PK), and Immunogenicity | — |
Contacts
Ono Pharmaceutical Co.,LTD.