ST1968 Intravenous (Weekly) in Solid Tumors

Inclusion Criteria:

- Histological/cytological diagnosis of solid tumors for which therapy of proven efficacy does not exist.

- Preferably measurable disease

- ECOG performance status ≤ 1.

- Age ≥ 18 years.

- Ongoing toxicity associated with prior anticancer therapy ≤ grade 1 (NCI-CTCAE V3.0).

- Maximum of 2 prior chemotherapy lines for advanced disease (not including neoadjuvant or adjuvant chemotherapy)

- Adequate hematological, liver and renal function

- Hemoglobin ≥ 9 g/dl; ANC ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L;

- Serum bilirubin ≤ upper normal limit (UNL). ALT, AST ≤ UNL but ≤ 2.5 x UNL in case of liver metastases; alkaline phosphatase (liver isoenzyme fraction) ≤ UNL or ≤ 1.5xULN in case of liver metastases; albumin within normal limits;

- Creatinine ≤1.5 mg/dl or calculated creatinine clearance ≥ 60 ml/min.

- Life expectancy of at least 3 months

- Capacity of understanding the nature of the trial and giving written informed consent.

Exclusion Criteria:

- Less than 4 weeks since last chemotherapy, radiotherapy or prior investigational therapy. Less than 2 weeks since last hormone or immunotherapy or signal transduction therapy.

- Active infection.

- Presence of cirrhosis or chronic hepatitis

- Presence of serious cardiac (congestive heart failure, angina pectoris, myocardial infarction within one year prior to study entry, uncontrolled hypertension or arrhythmia), neurological or psychiatric disorder.

- Presence of uncontrolled intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.

- Symptomatic brain metastases (this does not include primary brain tumors) or leptomeningeal disease.

- Pregnancy or lactation or unwillingness to use adequate method of birth control