A Phase I Study of MEDI9447 (Oleclumab) in Japanese Patients

Major Inclusion Criteria:

* Adult subjects; age ≥ 20 years
* Has a histologically confirmed solid malignancy that is refractory to standard therapy or for which no standard of care regimen currently exists
* Subjects must have at least 1 lesion that is measureable using RECIST v1.1
* All subjects must consent to provide archived tumor specimens for biomarker studies
* ECOG Performance Status of 0 or 1
* Life expectancy ≥12 weeks
* Adequate organ function
* Body weight ≥ 35 kg

Major Exclusion Criteria:

* Patients must have completed any previous cancer-related treatments before enrollment.
* Prior treatment with CD73 antagonist, tumor necrosis factor receptor superfamily agonists
* All CTLA-4, PD-1, or PD-L1 antagonists related-AEs must have resolved to ≤ NCI CTCAE v4.03 Grade 1 or baseline prior to screening and not worsened before the first dose of study drug
* Must not have required the use of additional immunosuppression other than corticosteroids for the management of an CTLA-4, PD-1, or PD-L1 related AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of \> 10 mg prednisone or equivalent per day
* Known allergy or hypersensitivity to the study drug, its compounds, or agents similar biologic composition
* History of more than one event of IRR requiring permanent discontinuation of IV drug treatment
* History of severe drug allergies or anaphylaxis to 2 or more food products or medicine
* Cardiac or peripheral vascular disease
* NCI CTCAE v4.03 Grade 3 or greater edema
* Uncontrolled massive ascites or pleural effusion
* History of NCI CTCAE v4.03 Grade 3 or greater thromboembolic events within 3 months prior to the first dose of study drug or thromboembolic event of any grade with ongoing symptoms
* Active tuberculosis
* Patients with history of, or current ILD
* Active or prior documented autoimmune within the past 3 years prior to the start of treatment
* Untreated or unstable CNS metastatic disease, leptomeningeal disease, or cord compression
* Concurrent enrollment in another clinical study
* Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment
* Toxicities from prior anticancer therapy that have not resolved to ≤ NCI CTCAE v4.03 Grade 1 or baseline prior to the first dose of study drug
* History of primary immunodeficiency or solid organ transplantation
* Active hepatitis B, hepatitis C, or HIV
* Females who are pregnant, lactating, or intend to become pregnant during their participation in the study
* Other invasive malignancy within 2 years prior to the first dose of study drug
* Uncontrolled concomitant illnes
* Judgment by the Investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements.
* Involvement in the planning and/or conduct of the study