Dose Escalation Study of the Safety and Pharmacokinetics of ME-344 Single Agent for Refractory Solid Tumors

Inclusion Criteria: * Provision of informed consent * Male or female ≥ 18 years of age * Histologic or cytologic confirmed locally advanced or metastatic cancer that has no standard therapeutic alternatives. * ECOG Performance status 0-1 (Appendix A) * A minimum life expectancy of 12 weeks * Adequate bone marrow, hepatic and renal function as evidenced by: * Absolute neutrophil count (ANC) \> 1.5 x 109/L * Platelet count \> 100 x 109/L * Hemoglobin \> 9.0 g/dL * Serum bilirubin \< 1.5 x ULN * AST/ALT (SGOT/SGPT) \< 2.5 x ULN for the reference laboratory or \< 5 x ULN in the presence of liver metastases * Serum creatinine \< 1.5 x ULN * Adequate cardiac function as evidenced by: * CK-MB within normal levels at baseline * Troponin T within normal levels at baseline * The average QTc from triplicate screening ECGs (every 5 minutes over a total of 15 minutes) must be \< 470 msec to be eligible for the study. (If a patient has an average QTc interval \>470 msec at screening, the screening ECG may be repeated twice (at least 24 hours apart). * LV Ejection Fraction \> lower limit of institutional normal level * All potentially fertile patients will agree to use an effective form of contraception during the study and for 30 days following the last dose of ME-344 (an effective form of contraception is defined as an oral contraceptive or a double barrier method). * At least 4 weeks must have elapsed prior to Day 1 Cycle 1 since prior chemotherapy (6 weeks for nitrosourea or mitomycin C), investigational drug or biologic therapy and any toxicity associated with these treatments has recovered to ≤ NCI-CTCAE Grade 1. * At least 21 days must have elapsed prior to Day 1 Cycle 1, radiotherapy, immunotherapy or following major surgery and any surgical incision should be completely healed. At least 14 days must have elapsed prior to Day 1 Cycle 1 for "limited palliative radiotherapy", defined as a course of therapy encompassing \<25% total bone marrow volume and not exceeding 30 Gy. Exclusion Criteria: * Patients who are pregnant or breastfeeding * Tumor involvement of the Central Nervous System (CNS): * Patients with treated and stable CNS metastases may be eligible to participate after discussion and approval from the Medical Monitor * Uncontrolled infection or systemic disease. * Clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease e.g. angina, and cardiac arrhythmias) or myocardial infarction within the last 12 months. * Any major surgery, radiotherapy, or immunotherapy within the last 21 days. Limited palliative radiation, defined as encompassing \<25% of total bone marrow volume and not exceeding a total dose of 30 Gy, within the last 14 days. * Chemotherapy regimens with delayed toxicity within the last 4 weeks (or within 6 weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens given continuously or on a weekly basis with limited potential or delayed toxicity within the last 2 weeks. * No concurrent systemic chemotherapy or biologic therapy is allowed. * Known hypersensitivity to any components of ME-344 study drug product. * Known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both). * History of solid organ transplantation. * Psychiatric disorder or social or geographic situation that would preclude study participation.