Safety and Efficacy of IV Nerofe™ Followed by Doxorubicin, In Metastatic Ovarian Cancer and Triple Negative Breast Cancer

Inclusion Criteria:

1. Females over18 years of age.
2. Pathologically confirmed locally advanced and/or metastatic solid tumor, for which, inthe judgment of the Principal Investigator, no standard curative therapy exists.
3. Subjects must have 1 of the following solid tumor types: Ovarian cancer (up to 12patients), or by Triple-negative breast cancer (up to 12 patients).
4. Disease that is evaluable, or measurable on imaging by Response Evaluation Criteria inSolid Tumors (RECIST v1.1 Appendix A), and where applicable is characterized byinformative tumor marker(s).
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2(Section 6.1.1.6) .
6. Acceptable clinical laboratory values at screening, as indicated by: Absolute neutrophil count ≥ 1,500/mm3; Platelets ≥ 75,000/mm3; Total bilirubin ≤ 5mg/dL. ASpartate aminoTransferase (SGOT) ≤ 2.5 × the Upper Limit of Normal; ALalanineaminoTransferase (SGPT) ≤ 2.5 × the Upper Limit of Normal; Serum creatinine ≤ 1.5mg/dL or a measured creatinine clearance higher than 60 mL/min; and Negative serumBeta human chorionic gonadotropin test in women of childbearing potential (defined aswomen ≤ 50 years of age or history of amenorrhea for ≤ 12 months prior to studyentry).
7. Patients with hepatic metastasis are eligible to enroll, provided that the followingcriteria are met at Screening: Total bilirubin ≤ 5 * mg/dL; ASpartate aminoTransferase and ALalanine aminoTransferaseare each ≤ 5 × the Upper Limit of Normal;
8. Willing and able to provide written Informed Consent and comply with the requirementsof the study.
9. Tumor tissue, taken from either an archival sample or a fresh biopsy, must beavailable for staining for T1/ST2 receptor, and must be ST2 positive.
10. Subject has not been previously treated with Doxorubicin or total accumulated dose hasnever exceeded 240 mg/m2.

Exclusion Criteria:

1. Any chemotherapy, immunomodulatory drug therapy, anti-neoplastic hormonal therapy (unless dose has been stable for 1 month prior to Baseline and remains stable duringthe trial), immunosuppressive therapy, corticosteroids > 20 mg/day prednisone orequivalent (unless administered to prevent contrast material reactions duringradiographic procedures), or growth factor treatment (eg, erythropoietin) within 14days prior to initiation of study drug.
2. Presence of an acute toxicity of prior chemotherapy, with the exception of alopecia orperipheral neuropathy, that has not resolved to ≤ Grade 1, as determined by NCI CTCAEv 4.0 (http://evs.nci.nih.gov/ftp1/CTCAE/About.html).
3. Receipt of >3 prior regimens of cytotoxic chemotherapy, including any use in theneo-adjuvant, adjuvant, and/or metastatic settings ,Unless more than 1 year elapsedsince the Neo-adjuvant treatment was completed
4. Receipt of Blood Transfusion during 2 weeks prior to Baseline
5. Life expectancy <12 weeks.
6. Major surgery or radiation therapy within 28 days prior to initiation of study drug,
7. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-relatedillness.
8. Patients with history of brain metastasis
9. Known active hepatitis B or C or other active liver disease (other than malignancy).
10. Severe liver dysfunction (Child-Pugh Class B or C) and
11. Patients with a history of esophageal bleeding have varices that have been sclerosedor banded and no bleeding episodes have occurred during the prior 6 months.
12. Active infection requiring systemic therapy.
13. Insulin-requiring diabetes mellitus will not be included if, according to theinvestigator, not stable, during the last 6 months.
14. History of any of the following within 12 months prior to initiation of study drug: Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), unstable angina, myocardial infarction, cerebrovascular accident,coronary/peripheral artery bypass graft surgery, transient ischemic attack, orpulmonary embolism (within the last 6 months). Left Ventricular Ejection Fraction <50% .
15. Uncontrolled arterial hypertension, or anti-hypertensive drugs whose type or dose hasbeen changed within 1 months prior to screening or whose dose is anticipated to changewithin cycle 1.
16. Risk of syncope, in the judgment of the Principal Investigator, according to thepatient's history of syncope.
17. History of ongoing cardiac dysrhythmias requiring drug treatment
18. Malignancies can be a reason for exclusion only if active during the last year orrequiring any anti-tumor treatment. Skin non-melanomatous tumors and thyroidcarcinomas - can be included. as well as, Previously treated malignancy within thepast 2 years that the Principal Investigator deems to be at low risk for recurrenceduring the course of this trial.
19. Use of any investigational agents within a minimum of 4 weeks or 5 half-lives ofinitiation of study drug.
20. Pregnant or lactating female.
21. Women of childbearing potential, unless they agree to use dual contraceptive methodswhich, in the opinion of the Principal Investigator, are effective and adequate forthat patient's circumstances while on study drug and for 3 months afterward.
22. Any severe, acute, or chronic medical or psychiatric condition, or laboratoryabnormality that may increase the risk associated with study participation or studydrug administration, may interfere with the informed consent process and/or withcompliance with the requirements of the study, or may interfere with theinterpretation of study results and, in the investigator's opinion, would make thepatient inappropriate for entry into this study.
23. Any known multiple allergy, or acute allergic reaction within the subject's medicalHistory or General Practitioner's records.