This is a Phase 1/2a, open label, dose escalation, repeat dose study in 11 subjects with recurrent, platinum resistant advanced stage ovarian cancer or primary peritoneal carcinoma designed to determine the tolerability, safety, quality of life, PK, and preliminary efficacy of DTA-H19 administered intraperitoneally(IP).~Primary Objective: The primary objectives of this study are:~To determine the maximum tolerated dose (MTD) of IP DTA-H19; and,~To identify any dose limiting toxicities (DLTs).~Secondary Objectives: Secondary objectives of this study are:~To determine quality of life of subjects with advanced ovarian cancer, primary peritoneal carcinoma treated with IP DTA-H19;~To determine the the reduction in malignant ascites as measured by Ultrasound and change in frequency of parecenteses necessary.~To determine the overall survival distribution.
This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of DTA-H19 administered intraperitoneally (IP) in subjects with advanced stage ovarian cancer, or primary peritoneal carcinoma