A Phase II Study of Sodium Cridanimod in Conjunction With Progestin Therapy in Patients With Progesterone Receptor Negative Recurrent or Persistent Endometrial Carcinoma

• Female patients age 18 and older;

• Histologically confirmed papillary serous adenocarcinoma or endometrioid type of endometrial carcinoma (histological documentation of recurrence is not required);

• Patient has documented evidence of PrR negative endometrial cancer. PrR negativity can be determined by immunohistochemistry. The tumor is considered PrR negative if the number of PrR positive cells is less than 1% determined by immunohistochemistry;

• Availability of tumor tissue sample that can be used for assessment of PrR levels with the use of immunohistochemistry;

• Recurrent or persistent (after the failure of chemotherapy) disease that cannot be treated with surgery or radiotherapy;

• Documented disease progression after a platinum based chemotherapy in patients for whom administration of taxanes and anthracyclines is not planned. Progression must fulfill one of the following criteria:

‣ Progression has occurred within 30 days of platinum based chemotherapy consisting of minimum of two cycles of cisplatin-based (≥60 mg/m2/cycle) or carboplatin-based (≥300 mg/m2/cycle, or area under the time-concentration curve ≥4) chemotherapy.

⁃ Progression after neoadjuvant or adjuvant platinum based chemotherapy if the recurrence occurred while on neoadjuvant/adjuvant chemotherapy or within 6 months since the last administration of such therapy.

• 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 progression is documented;

• GOG performance status 0-2;

• Glomerular filtration rate ≥ 50 mL/min;

• Total bilirubin normal;

• AST ≤ 2.5 times upper limit of normal (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;

• Ability to understand and the willingness to sign a written informed consent document.