An Endometrial Cancer Study for Women With Recurrent or Persistent Endometrial Cancer

Inclusion Criteria

• Female patients 18 years of age or older;
• Histologically confirmed serous carcinoma or endometrioid type of endometrial carcinoma (histological documentation of recurrence is not required);
• Recurrent or persistent progressive disease which is refractory to curative therapy or established treatments and cannot be treated with surgery or radiotherapy;
• Measurable disease, as defined by RECIST 1.1 criteria;
• At least one "target lesion" to be used to assess response, as defined by RECIST 1.1 criteria. Tumors within a previously irradiated field will be designated as "non-target" lesions unless previous progression is documented;
• Availability of archived tumor tissue sample that can be used for assessment of PrR status by the central laboratory;
• GOG (Gynecologic Oncology Group) performance status 0-2 (refer to Appendix A);
• Calculated Glomerular filtration rate ≥ 50 mL/min;
• Total bilirubin ≤ 2.5 times upper limit of normal (ULN);
• AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver metastases);
• Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver metastases);
• Albumin ≥ 3.0 mg/dL;
• Ability to take oral medication;
• Patients able to understand the nature of the study and who are willing to give written informed consent;
• And for Treatment Period 2 only: 1) Patients participating in Treatment Period 1 must have had disease progression after receiving at least 4 weeks of progestin therapy or 2) Patients must be determined as PrR negative status at Screening.

Exclusion Criteria

• Mixed histology of the tumor or evidence of tumor histology other than serous carcinoma or endometrioid type of endometrial carcinoma;
• Concurrent systemic corticosteroid therapy;
• Concurrent oral contraceptive use / Women of childbearing potential not using highly effective means of contraception;
• Pregnancy confirmed by pregnancy test / Lactating women;
• Prior therapy with hormonal progestin agents;
• Patients who are candidates for treatment with standard chemotherapy agents (there is no limit to the number of lines of chemotherapy);
• History of blood clot;
• History of known bleeding disorder (i.e. disseminated intravascular coagulation or clotting factor deficiency);
• Major surgery within 4 weeks prior to the start of the study;
• Patients with clinically significant illnesses which, according to the Investigator, could compromise participation in the study;
• History of other clinically active malignancies within 5 years, except for carcinoma in situ of the cervix, basal cell carcinoma, or squamous carcinoma of the skin.
• Known hypersensitivity or idiosyncratic reaction to any of the study drugs (Sodium Cridanimod, megestrol acetate, lidocaine) and excipients;
• Patients with known brain metastases;
• Patients currently receiving any other investigational agents;
• Patients currently receiving any other anticancer therapies;
• Participation in any other clinical study within the last 4 weeks prior to the start of the study