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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

Protocol No
SIRNAOMICS-SRN-705-005
Principal Investigator
Ben George
Phase
I
Summary
This clinical trial tests an investigational drug, STP705, that has shown through laboratory experiments to silence TGF-1 and COX-2 gene expressions, enzyme proteins believed to speed cancer growth in some cancers, which may result in tumor shrinkage when administered. The investigational drug, STP705 is not approved by the FDA.The major purposes of this study are to determine the maximum dose of STP705 that can be tolerated, and once this dose is found, if it has any effect in patients with liver tumors. This study is being performed: To test the safety of STP705 and see what effects (good and bad) it has on you and your cancer. To find the highest dose of STP705 that can be given without causing serious side effects when treatment is weekly for the first 3 of 4 weeks and monthly thereafter to a tumor in the liver. To find the dose of STP705 that should be used in future studies. To evaluate what the human body does to the study medication. This research is being performed because improvements are needed in the management of patients with cancer.
Description
This clinical trial tests an investigational drug, STP705, that has shown through laboratory experiments to silence TGF-1 and COX-2 gene expressions, enzyme proteins believed to speed cancer growth in some cancers, which may result in tumor shrinkage when administered.
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL