Study of Prolanta™ in Recurrent or Persistent Epithelial Ovarian Cancer

This trial is a Phase I open-label safety study of Prolanta™, a recombinant analog of the human prolactin protein with a single amino acid substitution to create an antagonist of the prolactin receptor. The Sponsor believes that blocking the prolactin receptor in patients with ovarian and other cancers will be effective as a monotherapy or in combination with other chemotherapies. This Phase I study will be conducted in Subjects with recurrent or persistent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

This study is a first-in-human study designed to establish preliminary human safety, tolerability and pharmacokinetic parameters of Prolanta monotherapy in patients with recurrent or persistent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. In addition, biomarkers related to the activity of human prolactin will be examined in tumor samples obtained prior to treatment and at the end of study treatment to determine the pharmacodynamics of the dose levels of Prolanta administered. Three dosing levels will be evaluated, and the dose at which no dose-limiting toxicities are observed will be the recommended Phase II dose. Because of its antagonist effect and the expected lower toxicity, Sponsor believes that Prolanta may be administered continuously as a monotherapy or in conjunction with the periodic administration of chemotherapy (i.e., a dual therapy). The dosing schedule to be used in this trial is designed to evaluate, in increments, the safety and tolerability of Prolanta over this 90 day cycle. Subjects will be assessed for antibody presence throughout the study, initially on a weekly basis and then bi-weekly. Subjects will be initially dosed for 28 days followed by a safety assessment period, and then continue for an additional 56 days if no toxicities are observed. The primary objectives of this study are to determine the safety and tolerability of Prolanta in women with recurrent ovarian cancer and to determine the optimal dose of Prolanta to use in Phase II studies. The safety evaluation will be determined by assessing treatment-emergent adverse events, physical examination, ECG, changes in clinical laboratory results including clinical chemistry, hematology and urinalysis, changes in pituitary hormone levels, and vital signs including blood pressure, pulse and respiratory rate. The optimal dose of Prolanta will be determined by evaluating both the safety profile and blood levels of Prolanta. If possible, the effect of the Prolanta dose on tumor biomarkers and tumor burden will also be used to determine the optimally bioactive Phase II dose level. The secondary objectives of this study are (i) to determine the pharmacokinetic parameters of Prolanta including Cmax, Tmax, half-life and area under the curve (AUC); (ii) to determine the effect of treatment with Prolanta on tumor markers; (iii) to determine clinical efficacy of Prolanta by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1