Liver Cancer SRN-705-005 (Phase 1)

Phase 1 Multicenter, Open-Label, Dose Escalation Study and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of STP705 Administered Intratumorally in Cholangiocarcinoma, Hepatocellular Carcinoma or Liver Metastases in Subjects With Advanced / Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy

This is an open label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of STP705 administered intratumorally in cholangiocarcinoma, hepatocellular carcinoma or liver metastasis in subjects with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy.

Eligibility Criteria:

• • 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
  • 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
  • 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
    • Aspirin, blood thinners, and non-steroidal anti-inflammatory drugs (NSAID) are prohibited for patients to be included in the study for their safety (PCL has been approved by WIRB)
  • Not had paracentesis in the last 3 months; presence of ascites must be controlled by diuretics
  • No History of hepatic encephalopathy in the last 6 months

This study is for patients age 18 and older.

Available at: Hartford Hospital