Recruiting
Phase 2

Relacorilant, Nab-Paclitaxel, Bevacizumab

Sponsor:

Corcept Therapeutics

Code:

NCT06906341

Conditions

Ovarian Cancer

Fallopian Tube Cancer

Peritoneal Neoplasms

Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Relacorilant 150 mg once daily (QD)

Nab-paclitaxel 80 mg/m^2

Bevacizumab 10 mg/kg

Study Details

Brief summary:

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.

Conditions

Ovarian Cancer

Fallopian Tube Cancer

Peritoneal Neoplasms

Endometrial Cancer

Study ID

NCT06906341

Start date

Apr 11, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 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 interfere with 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 interfere with 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 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.

Study Design

Enrollment

270 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: Relacorilant in Combination with Nab-paclitaxel and Bevacizumab

In Arm A, patients with platinum-resistant ovarian cancer will receive the combination of relacorilant with nab-paclitaxel and bevacizumab.

experimental: Arm B: Relacorilant in Combination with Nab-Paclitaxel and Bevacizumab

In Arm B, patients with platinum-sensitive ovarian cancer who have progressed while receiving treatment with a polymerase inhibitor will receive relacorilant in combination with nab-paclitaxel and bevacizumab.

experimental: Arm C: Relacorilant in Combination with Nab-Paclitaxel

In Arm C, patients with previously-treated advanced, recurrent, or metastatic endometrial cancer will receive relacorilant in combination with nab-paclitaxel.

Interventions

Relacorilant 150 mg once daily (QD)

Relacorilant is administered under fed conditions as capsules for oral dosing on the day before, the day of, and the day after nab-paclitaxel infusion.

Nab-paclitaxel 80 mg/m^2

Nab-paclitaxel is administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.

Bevacizumab 10 mg/kg

Bevacizumab is administered as IV infusion on Days 1 and 15.

Primary outcome measure

  • Progression-Free Survival (PFS) [ Time Frame: Date of first dose until PD or death, up to 18 months ]

Central Contacts and Locations

Central contacts

Corcept Therapeutics

650-414-2314corceptstudy557@corcept.com

Locations

004

Recruiting

Birmingham, Alabama, United States, 35233

150

Recruiting

Palo Alto, California, United States, 94304

014

Recruiting

San Francisco, California, United States, 94143

544

Recruiting

Fort Myers, Florida, United States, 33901

335

Recruiting

Miami Beach, Florida, United States, 33140

543

Recruiting

West Palm Beach, Florida, United States, 33041

518

Recruiting

Minneapolis, Minnesota, United States, 55404

334

Recruiting

Kansas City, Missouri, United States, 64132

521

Recruiting

St Louis, Missouri, United States, 63110

292

Recruiting

Albuquerque, New Mexico, United States, 97102

304

Recruiting

Centerville, Ohio, United States, 45459

517

Recruiting

Eugene, Oregon, United States, 97401

127

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

522

Recruiting

Fairfax, Virginia, United States, 22031

300

Recruiting

Norfolk, Virginia, United States, 23502

121

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Corcept Therapeutics

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • Genital Neoplasms, Female
  • Neoplasms by Site
  • Fallopian Tube Diseases
  • Ovarian Diseases
  • Neoplasms
  • Fallopian Tube Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Paclitaxel
  • Albumin-Bound Paclitaxel
  • Ovarian
  • Peritoneal or Advanced Fallopian Tube Cancer
  • High Grade
  • Platinum Resistant
  • Relacorilant
  • Bella
  • Nab-paclitaxel
  • Bevacizumab
  • Endometrial Neoplasm
  • Endometrial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Corcept Therapeutics on 2026-07-16.