Safety, Tolerability, PK, Anti-Tumor Activity of STP705 in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy

Inclusion Criteria

• •1. Subjects with histologically or cytologically confirmed advanced/metastatic or surgically unresectable cholangiocarcinoma, hepatocellular carcinoma, or other solid malignancy with one or more qualifying liver metastases who are refractory to standard therapy
• •* Have at least one liver tumor or metastasis (≤ 5 cm in size) that is not sub-capsular and not near any major blood vessel
• •* Have no more than 7 liver lesions
• •* Is deemed safe for percutaneous intra-tumoral injection by local radiologist
• •2. Measurable disease per RECIST v 1.1 (primary or metastatic disease)
• •3. ECOG performance status or 0 - 1
• •4. Life expectancy of at least 3 months
• •5. Age ≥ 18 years
• •6. Signed, written Institutional Review Board (IRB) approved informed consent
• •7. A negative serum pregnancy test (for nonsterile women of child-bearing potential)
• •8. Baseline Q-T corrected interval (QTc) interval of ≤ 480 msec using Frederica's formula
• •9. Acceptable liver function:
• •* Bilirubin ≤ 1.5 times upper limit of normal
• •* AST (SGOT), ALT (SGPT) and Alkaline phosphatase ≤ 5 times upper limit of normal because of cancer or metastases to the liver
• •10. Acceptable renal function, defined as:
• •o Serum creatinine ≤ 1.5 ULN or Creatinine Clearance ≥ 30 mL/minute
• •11. Acceptable hematologic status:
• •* Hemoglobin ≥ 8 g/dL (a transfusion is allowed if Hemoglobin stays stable thereafter)
• •* Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
• •* Platelet count ≥100,000 plt/mm3 x 109/ L (≥ 65,000 if low platelet counts are due to splenic sequestration and portal hypertension)
• •12. Urinalysis with no clinically significant abnormalities
• •13. Acceptable coagulation status with partial thromboplastin time (PTT) and International Normalized Ratio (INR) ≤1.5 times upper limit of normal
• •14. Subject has adequate vitamin D level, as defined by serum total 25-Hydroxyvitamin D \[25(OH)D\] ≥ 20 to \< 60 ng/mL
• •15. Completion of all previous treatments (including surgery, systemic chemotherapy and radiotherapy), as well as supportive care (including transfusion of blood, blood components and granulocyte colony-stimulation factor \[G-CSF\] treatment) at least 3 weeks before screening (6 weeks for nitrosoureas or mitomycin C), with no signs or symptoms of acute toxicity \> Grade 1 (except alopecia)
• •16. For men and women of child-producing potential, the use of effective contraceptive methods during the study
• •17. No aspirin for ≥ 5 days in advance of intra-tumoral administration, as well as discontinuation of antiplatelet and anticoagulant medications for the appropriate amount of time