Safety, Tolerability, and Immunoregulatory Activity of Mogamulizumab (KW-0761) in Subjects With Advanced and/or Metastatic Solid Tumors

Inclusion Criteria

• •Informed Consent form signed by the subject.
• •Males and females 18 years or older at the time of dose initiation.
• •Histologically confirmed unresectable solid tumor malignancy with at least 1 measurable lesion. In the expansion phase, eligibility will be limited to metastatic triple negative breast cancer that has received prior taxane and anthracycline therapy; Metastatic NSCLC that is not ALK+ and does not have a EGFR sensitizing mutation; and metastatic gastric cancer
• •Previously treated for an advanced cancer and there are no curative therapy options available
• •Karnofsky Performance Status ≥70 in the 30 day baseline period immediately prior to dosing.
• •Evidence of adequate organ function by standard laboratory tests:
• •* Serum creatinine (Cr) ≤1.5 X upper limit of normal (ULN)
• •* Serum total and (T -Bil ) ≤1.5 X ULN (prior diagnosis or past history consistent with Gilbert's syndrome is an exception)
• •* Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X ULN
• •* Platelets (Plts) ≥ 100,000/μl
• •* Hemoglobin (Hgb) ≥ 9.0 g/dL
• •* Absolute neutrophil count (ANC) ≥1000/mm3
• •All female subjects of childbearing age must be either surgically sterile, postmenopausal for at least 1 year, or using an acceptable method of contraception. Examples of adequate methods of contraception include abstinence, intrauterine device, hormonal contraception, use of spermicide and a condom by sexual partner, or partner with a vasectomy. Adequate contraception must be used from the beginning of the screening period until at least 16 weeks after the last dose of KW-0761. Male subjects with partners of childbearing potential must use a barrier method of contraception from the day of the first dose of KW-0761 until at least 16 weeks after the last dose.
• •Life expectancy \> 12 weeks
• •Previously treated for advanced cancer with no additional therapy options available known to prolong survival.