Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers

Inclusion Criteria:

Arms A and B

• Histologic diagnosis of epithelial ovarian, primary peritoneal, or fallopian-tubecarcinoma

• Arm A Only: Platinum-resistant disease

• Arm B Only: Platinum-sensitive disease who had progression while receiving treatmentwith a poly(ADP-ribose) polymerase (PARP) inhibitor

• Life expectancy of ≥3 months

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

• Able to swallow and retain oral medication

• 1 to 3 lines of prior systemic anticancer therapy

• Adequate organ function

• Negative pregnancy test for patients of childbearing potential

Arm C

• Stage III or IV, recurrent, or metastatic endometrial cancer

• Life expectancy of ≥3 months

• ECOG performance status of 0 or 1

• Able to swallow and retain oral medication

• Prior treatment with a platinum agent and an approved anti-Programmed Cell DeathLigand 1 (PD[L]1) antibody

• 1 to 2 lines of prior systemic anticancer therapy for endometrial cancer

• Must consent to provide an available formalin-fixed paraffin-embedded (FFPE) tumortissue block or recently cut sections

• Adequate organ function

• Negative pregnancy test for patients of childbearing potential

Exclusion Criteria:

Arm A and B

• Arm A Only: Has progressed while receiving weekly paclitaxel or nab-paclitaxel

• Prior enrollment in a clinical trial of relacorilant

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

• Any surgery within 4 weeks prior to enrollment

• 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

• Bowel obstruction ≤12 weeks prior to study entry

• Ascites or pleural effusions requiring therapeutic paracentesis

• 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

Arm C

• Has progressed while receiving weekly paclitaxel or nab-paclitaxel

• Prior enrollment in a clinical trial of relacorilant

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

• Any surgery within 4 weeks prior to enrollment

• 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

• Uncontrolled condition(s) which, may confound the results of the trial or interferewith the patient's safety or participation

• Bowel obstruction ≤12 weeks prior to study entry

• Ascites or pleural effusions requiring therapeutic paracentesis

• History of other malignancy within 3 years prior to enrollment

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

• Patients with central nervous system metastases are not eligible, unless they havecompleted local therapy and have discontinued the use of corticosteroids for thisindication for at least 4 weeks before starting treatment in this study.