Relacorilant in Combination With Nab-paclitaxel and Bevacizumab in Advanced, Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer

Inclusion Criteria:

• Histologic diagnosis of high-grade serous/endometrioid, epithelial ovarian, primaryperitoneal, or fallopian-tube carcinoma.

• Platinum-resistant disease (defined as progression <183 days from the last dose ofplatinum).

• At least 1 measurable (target) lesion per RECIST version 1.1.

• Life expectancy of ≥3 months.

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

• Able to swallow and retain oral medication and does not have uncontrolled emesis.

• 1 to 3 lines of prior systemic anticancer therapy for ovarian cancer.

1. ≥1 prior line of platinum-based therapy.

2. Prior treatment with bevacizumab allowed.

• Adequate organ function meeting the following laboratory-test criteria:

1. Absolute neutrophil count (ANC) ≥1500 cells/mm^3.

2. Platelet count ≥100,000/mm^3.

3. Hemoglobin ≥9 g/dL.

4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5 × upperlimit of normal (ULN), or ≤5 × ULN if liver metastases.

5. Total bilirubin ≤1.5 × ULN.

6. Albumin ≥2.5 g/dL.

7. Calculated creatinine clearance ≥35 mL/min.

8. Urine protein <2+ by dipstick; if ≥2+, 24-hour urine <1 g of protein.

• Negative pregnancy test for patients of childbearing potential.

Exclusion Criteria:

• Has progressed while receiving weekly (every week or 3 out of 4 weeks) paclitaxel ornab-paclitaxel in the platinum-resistant ovarian cancer (PROC) setting.

• Prior anticancer therapy related toxicities not resolved to grade ≤1.

• Any surgery within 4 weeks prior to enrollment.

• Prior treatment as follows:

1. Chemotherapy, immunotherapy, investigational agent etc. within 5 times thehalf-life of the prior therapy, or 28 days if 5 times the half-life of theprior therapy is >28 days, before the first dose of study treatment.

2. Radiotherapy not completed ≤2 weeks prior to first dose of study treatment.

3. Hormonal anticancer therapies within 7 days of first dose of study treatment.

4. Corticosteroids used within a period equivalent to 5 times the half-life of thecorticosteroid prior to first dose of study treatment.

• Wide-field radiation to more than 25% of marrow-bearing areas.

• Medical conditions requiring chronic or frequent treatment with corticosteroids.

• Concurrent treatment with mifepristone or other glucocorticoid receptor modulators.

• Peripheral neuropathy from any cause >Grade 1.

• Hypertension: ≥150 mm Hg systolic or ≥100 mm Hg diastolic.

• Uncontrolled condition(s) which, may confound the results of the trial or interferewith the patient's safety or participation, including unstable angina, myocardialinfarction within 6 months prior to the first dose of study treatment, New YorkHeart Association (NYHA) Class II or greater congestive heart failure, seriousarrhythmias requiring medication, severe/advancing cirrhosis, active infectiousdisease requiring IV therapy within 2 weeks prior to the first dose of studytreatment, gastric-outlet obstruction, acute renal failure, known psychiatricdisorder that would interfere with trial compliance.

• Bowel obstruction ≤12 weeks prior to study entry.

• Ascites or pleural effusions requiring therapeutic paracentesis or thoracentesiswithin the 30 days prior to study entry or anticipated within 30 days of C1D1.

• Non-healing wound, ulcer, or bone fracture.

• History of abdominal fistula, gastrointestinal perforation, or intraabdominalabscess within 6 months prior to C1D1.

• Evidence of recto-sigmoid involvement by ovarian cancer.

• Anticoagulants or thrombolytic agents use for therapeutic purpose within 10 daysprior to study treatment start.

• Active infection with HIV, hepatitis C or hepatitis B virus.

• Untreated or symptomatic central nervous system metastases.

• History of other malignancy within 3 years prior to enrollment.

• Has received a live vaccine within 30 days prior to the study start date.