Study of Mogamulizumab + Nivolumab in Subjects w/Locally Advanced or Metastatic Solid Tumors

Inclusion Criteria

• Subject is age 18 years or older;
• Subject must have histologically or cytologically confirmed solid tumor;
• Subject must have locally advanced or metastatic solid tumor;
• Subjects who have progressed or have been intolerant to any standard treatment regimen or refused standard treatment, or for which adequate standard therapy does not exist.
• Subjects who have evaluable lesion per guideline of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Subject has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
• If the subject is a woman of child-bearing potential or man who is sexually active with woman of child-bearing potential, the subject agrees to use adequate contraception from signing of the ICF, for the duration of study participation; and for 23 weeks after the last dose of IMP for women or 31 weeks after the last dose of IMP for men;
• Subjects who have adequate hematological, renal, hepatic and respiratory functions defined.
• The subject is willing to undergo tumor biopsy during the Screening period, or if the tumor is inaccessible for biopsy, archived tumor material must be available for submission;
• Subjects who voluntarily signed and dated Institutional Review Board approved informed consent form in accordance with regulatory and institutional guidelines.

Hepatocellular Carcinoma Inclusion Criteria:

• Histologically confirmed hepatocellular carcinoma not amenable for management with curative intent by surgery or local therapeutic measure;
• Subject must have received sorafenib treatment and either:
• have had documented radiographic or symptomatic progression during or after sorafenib therapy; OR
• be intolerant of sorafenib (defined as Grade 2 drug-related adverse event which 1) persisted in spite of comprehensive supportive therapy according to institutional standards AND 2) persisted or recurred after sorafenib treatment interruption of at least 7 days and dose reduction by one dose level (to 400 mg once daily) AND/OR Grade 3 drug-related adverse event which 1) persisted in spite of comprehensive supportive therapy according to institutional standards OR 2) persisted or recurred after sorafenib treatment interruption of at least 7 days and dose reduction by one dose level (to 400 mg once daily); OR must have documented refusal of sorafenib;
• Subject has Child-Pugh score of ≤6, i.e., Child-Pugh A (Appendix 2);
• INR ≤ 2.3 or Prothrombin time (PT) ≤ 6 seconds above control;
• Subject has HBV DNA viral load undetectable or 1 from previous anti-cancer therapy
• Subject use of immunosuppressive medication within 14 days before Cycle 1 Day 1.
• Subjects who have known active autoimmune disease or a history of autoimmune disease which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids;
• Subjects who have history of toxic epidermal necrolysis or Stevens-Johnson syndrome;
• Subjects who have a history of inflammatory bowel disease, Crohn's disease, ulcerative colitis, or Wegener's granulomatosis;
• Subject has primary or acquired immunodeficiency or known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome;
• Subject who tests positive for hepatitis B surface antigen (HBVsAg) or hepatitis C RNA indicating acute or chronic infection except for subjects with hepatocellular carcinoma;
• Subject has another active malignancy requiring concurrent intervention;
• Subject who is receiving any other investigational agents;
• Subject has another condition that, in the opinion of the Investigator and/or Sponsor, would interfere with evaluation of the IMP or interpretation of subject safety or study results;
• Subject has a history of pneumonitis or interstitial lung disease.

Hepatocellular Carcinoma Exclusion Criterion:

• Any history of hepatic encephalopathy
• Any prior (within 1 year) or current clinically significant ascites as measure