ONO-4538 Phase I Study in Patients With Advanced Malignant Solid Tumors in Japan

ONO-4538 Phase I Study - A Single Center, Open Label, Dose Escalation Single Dose, Followed by Multiple Dose Study of ONO-4538, a Fully Human mAb to PD-1, in Patients With Advanced Malignant Solid Tumors

Evaluation of the safety, tolerability and pharmacokinetics (PK) of a single dose and multiple doses of ONO-4538 in Japanese patients with advanced malignant solid tumors, and exploratory evaluation of the pharmacological effect and efficacy of ONO-4538.

Inclusion Criteria:

• Histological or cytological diagnosis of solid tumor with at least one measurable lesion of ≥ 10mm.
• Tumor must be advanced or recurrent which is refractory to standard therapies or for which no alternative, appropriate therapy exists.
• ECOG Performance Status of 0-1
• Life expectancy ≥ 3 months
• Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

• History of severe hypersensitivity reactions to other antibodies.
• Residual adverse reactions or effect of prior therapy, which deemed to affect the safety evaluation of the study drug by the investigator or subinvestigator.
• Two or more synchronous tumors, except for adequately treated basal cell cancer or cancer in situ, or superficial bladder cancer, or any other cancers from which the patient has been disease-free for at least 5 years.
• Patients with any active autoimmune disease or a documented history of chronic or recurrent autoimmune disease, or current medical condition that requires systemic immunosuppressive doses of steroids or other immunosuppressive medications.
• Other exclusion criteria as specified in the study protocol