Phase I Dose Escalation Study of the Safety and Pharmacokinetics of ME-143 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
* 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) \< or = 2.5 x ULN for the reference laboratory or \< 5 x ULN in the presence of liver metastases
  * Serum creatinine \< or = 1.5 x ULN
  * Follicle-Stimulating Hormone (FSH) within normal baseline levels
  * Male patients should have a detectable level of testosterone
* Female patients who are known to be capable of conception should have a negative serum pregnancy test (beta-human chorionic gonadotropin β-hCG\]) within 1 week of starting the study.
* All potentially fertile patients will agree to use an effective form of contraception during the study and for 90 days following the last dose of ME-143 (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 carmustine 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 (limited palliative radiation is allowed \> 2 weeks), immunotherapy or following major surgery and any surgical incision should be completely healed

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.
* Patients with QTc of \> 470 msec on screening ECG. (If a patient has QTc interval \>470 msec on screening ECG, the screening ECG may be repeated twice (at least 24 hours apart). The average QTc from the 3 screening ECGs must be \<470 msec in order for the patient to be eligible for the study.
* Any major surgery, radiotherapy, or immunotherapy within the last 21 days (limited palliative radiation is allowed \> 2 weeks).
* 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-143 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.