- Patient must have measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥10 mm with CT scan, as ≥20 mm by chest x-ray, or ≥10 mm with calipers by clinical exam (Expanded Cohort only; patients without measurable disease by RECIST 1.1 criteria but with evaluable disease will be eligible for the dose-finding phase).