Phase I Study of U3P1287/01, Including Patients With Advanced Solid Tumors

Key Inclusion Criteria:

• Pathologically or cytologically documented advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available, or the patient refuses standard therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Men or women at least 18 years of age
• Adequate hematologic, cardiac, renal, hepatic, metabolic, and coagulation function

Key Exclusion Criteria:

• Presence of untreated or symptomatic brain metastasis.
• Presence of ascites or pleural effusion requiring chronic medical intervention.
• Uncontrolled hypertension
• Concurrent or previous (within 1 week of study day 1) anticoagulation therapy, except low-dose warfarin (≤ 2 mg/day) or low dose,low molecular weight heparin for prophylaxis against central venous catheter thrombosis.
• Recent major surgical procedure or not yet recovered from major surgery
• Recent participation in clinical drug trials.
• Participation in other investigational procedures.
• Unresolved toxicities from prior anti-cancer therapy
• Patient who is pregnant (e.g. positive human choriogonadotropin [HCG] test) or nursing.