Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer

Inclusion Criteria:

1. Signed informed consent form.

2. Age 18 years or older.

3. Histologically or cytologically documented epithelial ovarian, fallopian tube, orprimary peritoneal tumors, with high-grade serous or endometrioid, or predominantlyserous/endometrioid histology (independent of BRCA1 and HRD status).

4. Patients must have platinum-resistant disease, defined as progression within 6months after the last dose of platinum-based chemotherapy, or are platinumineligible.

5. Patients have received no more than one line of therapy in the platinum resistant orplatinum ineligible setting. Note: Prior ADCs therapy (e.g., Elahere) will not counttowards this previous line of therapy.

6. Measurable disease by CT scan or MRI. Note: Baseline tumor assessment will beperformed within 4 weeks prior to Day 1 Cycle 1

7. Performance status of ECOG ≤ 1.

8. Patients must have a life expectancy of >16 weeks.

9. Recovered to Grade 1 or less from prior surgery or acute toxicities of priorradiotherapy, or treatment with cytotoxic, hormonal, or biologic agents.

10. Adequate conditions as evidenced by the following clinical laboratory values:

11. Absolute neutrophils count (ANC) ≥ 1.5 x 103 μL

12. Hemoglobin > 9.0 g/dL

13. Platelets ≥ 100 x 103 μL

14. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkalinephosphatase ≤ 2.5 x ULN, unless liver metastases are present, in which casethey must be ≤5 x ULN

15. Serum bilirubin ≤ 1.5 ULN

16. Creatinine ≤ 1.5 ULN

17. Blood urea nitrogen (BUN) ≤2X ULN.

18. FFPE tumor tissue should be available from the current relapse, if obtainable,otherwise the most recent archival tumor tissue. Note: Patients treated with a PARPinhibitor must have a new biopsy unless there is an archival biopsy that was doneafter the PARP inhibitor treatment was discontinued.

19. Negative serum pregnancy test in women of childbearing potential (WOCBP). WOCBP isdefined as premenopausal women or less than 12 months of amenorrhea post-menopause,and women who have not undergone surgical sterilization or hysterectomy or bilateralsalpingo-oophorectomy.

20. Sexually active females of childbearing potential must use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception) forthe study duration and at least six months afterwards.

Exclusion Criteria:

1. Patients who have platinum-refractory disease, defined as progression during thelast platinum-based chemotherapy.

2. Concurrent chemotherapy, antibody therapies radiotherapy,hormonal therapy, or otherinvestigational drug except non-disease related conditions (e.g. insulin fordiabetes) during study period.

3. Other malignancy with exception of any stage I and II cancer that is deemed cured bythe Investigator.

4. Any active infection requiring parenteral or oral antibiotic treatment.

5. Known HIV positivity.

6. Known active hepatitis B or C.

7. Clinically significant cardiovascular disease:

8. Stroke within ≤ 12 months prior to day 1

9. Transient ischemic attach (TIA) within ≤ 12 months prior to day 1

10. Myocardial infarction within ≤ 12 months prior to day 1

11. Unstable angina

12. New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF)

13. Uncontrolled cardiac arrhythmia requiring medication

14. Other medications or conditions that in the Investigator's opinion wouldcontraindicate study participation for safety reasons or interfere with theinterpretation of study results.

15. Inability to take oral medication, or malabsorption syndrome or any otheruncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) thatmight impair the bioavailability of 2X-121.

16. Requiring immediate palliative treatment of any kind including surgery and/orradiotherapy.

17. Patients unable to be regularly followed for any reason (geographic, familiar,social, psychological, housed in an institution e.g., prison because of a courtagreement or administrative order).

18. Patients, who are close colleagues, associates, or family members of, or in any waydependent on the sponsor or the investigator.

19. Ascites requiring drainage >500cc in the 2 weeks prior to enrolment.