ONO-4538 Phase I Study in Patients With Solid Tumor

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

The objective of this study is to investigate the safety, pharmacokinetics, pharmacology and efficacy 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:

• The treatment phase has been completed in the ONO-4538-13 study

Exclusion Criteria:

• The development of PD is identified by the principal or sub investigator according to the RECIST guideline (version 1.1) only in case in which the unplanned tumor assessment with diagnostic image is performed in the treatment phase of ONO-4538-13 study.
• It is determined that continuing the treatment is not appropriate because the worsening of clinical symptoms attributed to disease progression occurs.