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
- 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
- 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