ONO-4538 Phase I Study in Patients With Solid Tumor

ONO-4538 Multicenter, Open-label, Uncontrolled, Phase I Study in Solid Tumor

The objective of the study is to investigate the pharmacokinetics of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available.

Inclusion Criteria:

• Male or female ≥ 20 years of age
• Histologically or cytologically confirmed solid tumor
• Patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available
• ECOG Performance Status is 0 to 1

Exclusion Criteria:

• Current or prior severe hypersensitivity to another antibody product
• Multiple primary cancers