An Open-label, Global, Multi-Arm Study to Evaluate the Efficacy and Safety of Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers (BELLA)
This is a Phase 2, open-label, global, multi-arm study to evaluate efficacy and safety of relacorilant in combination with other treatments in patients with gynecological cancers.
⁃ Arms A and B
• Histologic diagnosis of epithelial ovarian, primary peritoneal, or fallopian-tube carcinoma
• Arm A Only: Platinum-resistant disease
• Arm B Only: Platinum-sensitive disease who had progression while receiving treatment with 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 Death Ligand 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) tumor tissue block or recently cut sections
• Adequate organ function
• Negative pregnancy test for patients of childbearing potential