Phase I Ascending Multiple-Dose Study of BMS-986115 in Subjects With Advanced Solid Tumors

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Subjects with a histologically or cytologically confirmed diagnosis of solid tumors, advanced or metastatic, refractory to or relapsed from standard therapies or for which there is no known effective treatment
* Life expectancy of at least 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
* Prior anti-cancer treatments are permitted (i.e., chemotherapy, radiotherapy, hormonal, or immunotherapy)
* At least 4 weeks must have elapsed from last dose of prior anti-cancer therapy and the initiation of study therapy

Exclusion Criteria:

* Subjects with known or suspected brain metastases, primary brain tumors, or brain as the only site of disease
* Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti-fungal therapy ≤ 7 days prior to administration of study medication
* Current or recent (within 3 months of study drug administration) gastrointestinal disease such as chronic or intermittent diarrhea, or disorders that increase the risk of diarrhea, such as inflammatory bowel disease. Non-chronic conditions (e.g. infectious diarrhea) that are completely resolved for at least 2 weeks prior to starting study treatment are not exclusionary
* Any major surgery or gastrointestinal disease that would interfere with administration of oral medications
* Conditions requiring chronic systemic glucocorticoid use, such as autoimmune disease or severe asthma, excluding inhalation steroids for maintenance.
* Uncontrolled or significant cardiovascular disease
* History of medically significant thromboembolic events or bleeding diathesis within the past 6 months
* Inadequate bone marrow function (Absolute neutrophil count (ANC) \< 1,500 cells/mm3; Platelet count \< 100,000 cells/mm3; Hemoglobin \< 9.0 g/dL)
* Inadequate hepatic function (Total bilirubin \> 1.5 times the institutional upper limit of normal (ULN) (except known Gilbert's syndrome); Alanine transaminase (ALT) or aspartate transaminase (AST) \> 2.5 times the institutional ULN. ALT or AST up to 3 times the institutional ULN permitted if total bilirubin is normal
* Uncontrolled (≥ Grade 2) hypertriglyceridemia (fasting triglycerides \> 300 mg/dL (3.42 mmol/L))
* Inadequate renal function (Blood creatinine \> 1.5 times the institutional ULN)
* Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus (HIV) -1, -2 antibody