Tests relacorilant with other treatments for gynecological cancers

Trial details

Who runs it

Corcept Therapeutics

Trial code

NCT06906341

Record updated

16 July 2026

Original description

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.Read full original descriptionShow less

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.

Inclusion: 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.

Exclusion: 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; Bowel obstruction ≤12 weeks prior to study entry; 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; Bowel obstruction ≤12 weeks prior to study entry; 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 have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study; Hypertension: ≥150 mm Hg systolic or ≥100 mm Hg diastolic; Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation; History of other malignancy within 3 years prior to enrollment; Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation; History of other malignancy within 3 years prior to enrollment; Arm A and B; Peripheral neuropathy from any cause >Grade 1; Ascites or pleural effusions requiring therapeutic paracentesis; Untreated or symptomatic central nervous system metastases; Peripheral neuropathy from any cause >Grade 1; Ascites or pleural effusions requiring therapeutic paracentesis.

ClinicalTrials.gov NCT06906341