A Phase 2 Study of Kevetrin in Subjects With Ovarian Cancer

Inclusion Criteria

• Evidence of a personally signed and dated written informed consent to participate in the clinical study
• Non-pregnant female adults at least 18 years of age at time of informed consent
• Histologically confirmed serous epithelial ovarian cancer with peritoneal metastases
• Platinum resistant/refractory disease, defined as disease progression/relapse within 6 months following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively
• Measurable disease, as determined by radiologist evaluator, with at least 1 unidimensional measurable lesion (target lesion) by RECIST v.1.1 that has not previously been irradiated or biopsied
• Presence of non-target lesions that have not previously been irradiated or biopsied; to allow for collection of needle-biopsies at Screening and after completion of Kevetrin treatment
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate hematologic and organ function as confirmed by laboratory values at Screening:
• Bone marrow function: Absolute neutrophil count (ANC) ≥ 1500 Cells/μL (with no evidence that this ANC was induced or supported by granulocyte colony stimulating factors)
• Hemoglobin ≥ 9 g/dL (with no RBC transfusions within 7 days of Screening)
• Platelets ≥ 100, 000 cells/μL (with no evidence that this platelet count was induced or supported by a platelet-stimulating agent)
• Renal function: creatinine ≤ 1.5 x ULN
• Hepatic function: total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 3 x ULN; alkaline phosphatase ≤ 2.5 x ULN
• Neurologic function: neuropathy (sensory and motor) ≤ CTCAE Grade 1
• Coagulation status: prothrombin time (PT) ≤ 1.5 ULN or INR within normal limits; and partial thromboplastin time (PTT) ≤ 1.2 × ULN
• Women of child-bearing potential are required to use effective contraception throughout the study period. Effective contraception methods include:
• Total abstinence (if this is the usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. (Subject must agree to use contraception should they become sexually active while on the study.)
• Surgical sterilization (hysterectomy and/or bilateral oophorectomy) or tubal ligation at least six weeks before start of study treatment.
• Male partner sterilization, occurring at least 6 months prior to screening. For female subjects on the study, the vasectomized male partner should be their sole partner.
• Double barrier method: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
• Oral*/ injected/ implanted/ transdermal hormonal contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), e.g., hormone vaginal ring.
• Intrauterine device or intrauterine system. *Stable oral contraception use (on the same pill) for a minimum of 3 months before taking study treatment.

Women are considered post-menopausal and not of child-bearing potential if they have had 12 consecutive months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical hysterectomy and/or bilateral oophorectomy or tubal ligation at least six weeks ago.

• Estimated life expectancy of at least 6 months, in the Investigator's opinion
• Willing and able to comply with scheduled visits, study assessments and laboratory tests, and other study procedures

Exclusion Criteria

• Unwilling to allow removal of tumor biological samples for analysis, i.e., biopsies of tumor lesions, and/or collection of ascites fluid from abdominal ascites (if present)
• Non epithelial tumor, including malignant mixed Müllerian tumors without high grade serous component, or ovarian t