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

April 9, 2026 updated by: Corcept Therapeutics

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is designed with the goal to add additional arms as new treatments become available. All arms will follow an independent and parallel design.

For Arms A and B, study treatment will comprise relacorilant combined with nab-paclitaxel, and bevacizumab and will begin on Cycle 1 Day 1 (C1D1). Each patient will receive relacorilant 150 mg administered orally under fed conditions, once daily for 3 consecutive days on the day before, the day of, and the day after nab-paclitaxel infusion (in Cycle 1 relacorilant is only given on 2 consecutive days, starting on C1D1), in combination with nab-paclitaxel (80 mg/m^2 intravenously [IV]) administered on Days 1, 8, and 15 of each 28-day cycle. Bevacizumab (10 mg/kg IV once every 2 weeks [Q2W]) will be administered on Days 1 and 15 of each 28-day cycle. Study treatment for Arm C will be similar to Arm A but does not include bevacizumab. Patients will receive treatment until they reach a protocol-defined event of progressive disease (PD), experience an unmanageable toxicity, or until other treatment discontinuation criteria are met.

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • Recruiting
        • 328
      • Charleroi, Belgium, 6000
        • Recruiting
        • 326
      • Hasselt, Belgium, 3500
        • Recruiting
        • 325
      • Leuven, Belgium, 3000
        • Recruiting
        • 108
  • France
      • Lille, France, 59000
        • Recruiting
        • 306
      • Nancy, France, 54100
        • Recruiting
        • 307
      • Nice, France, 06100
        • Recruiting
        • 310
      • Pierre-Bénite, France, 69495
        • Recruiting
        • 324
      • Plérin, France, 22190
        • Recruiting
        • 323
      • Toulouse, France, 31059
        • Recruiting
        • 308
  • Germany
      • Aachen, Germany, 52074
        • Recruiting
        • 519
      • Berlin, Germany, 10117
        • Recruiting
        • 255
      • Kempten, Germany, 87439
        • Recruiting
        • 520
  • Italy
      • Catania, Italy, 95126
        • Recruiting
        • 321
      • Milan, Italy, 20141
        • Recruiting
        • 122
      • Milan, Italy, 20159
        • Recruiting
        • 516
      • Pavia, Italy, 27100
        • Recruiting
        • 295
      • Rome, Italy, 00168
        • Recruiting
        • 124
      • Torino, Italy, 10128
        • Recruiting
        • 293
      • Treviso, Italy, 31100
        • Recruiting
        • 319
  • Poland
      • Gdynia, Poland, 81-519
        • Recruiting
        • 341
      • Siedlce, Poland, 08-MO
        • Recruiting
        • 329
  • South Korea
    • Gangnam-gu
      • Seoul, Gangnam-gu, South Korea, 06351
        • Recruiting
        • 396
    • Goyang-si
      • Gyeonggi-do, Goyang-si, South Korea, 10408
        • Recruiting
        • 397
    • Jongno-gu
      • Seoul, Jongno-gu, South Korea, 03080
        • Recruiting
        • 399
    • Seocho-gu
      • Seoul, Seocho-gu, South Korea, 06591
        • Recruiting
        • 523
    • Seodaemun-gu
      • Seoul, Seodaemun-gu, South Korea, 03722
        • Recruiting
        • 398
    • Songpa-gu
      • Seoul, Songpa-gu, South Korea, 05505
        • Recruiting
        • 403
  • Spain
      • Badalona, Spain, 08916
        • Recruiting
        • 349
      • Barcelona, Spain, 08035
        • Recruiting
        • 115
      • Madrid, Spain, 28034
        • Recruiting
        • 114
      • Valencia, Spain, 46026
        • Recruiting
        • 330
      • Valencia, Spain, 46010
        • Recruiting
        • 558
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • 004
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • 150
      • San Francisco, California, United States, 94143
        • Recruiting
        • 014
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Recruiting
        • 544
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • 335
      • West Palm Beach, Florida, United States, 33041
        • Recruiting
        • 543
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Recruiting
        • 518
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Recruiting
        • 334
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • 521
    • New Mexico
      • Albuquerque, New Mexico, United States, 97102
        • Recruiting
        • 292
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • 304
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • 517
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • 127
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • 522
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • 300
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • 121

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: 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.
Other Names:
  • CORT125134
Drug: Nab-paclitaxel 80 mg/m^2
Nab-paclitaxel is administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
Drug: Bevacizumab 10 mg/kg
Bevacizumab is administered as IV infusion on Days 1 and 15.
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.
Drug: 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.
Other Names:
  • CORT125134
Drug: Nab-paclitaxel 80 mg/m^2
Nab-paclitaxel is administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
Drug: Bevacizumab 10 mg/kg
Bevacizumab is administered as IV infusion on Days 1 and 15.
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.
Drug: 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.
Other Names:
  • CORT125134
Drug: Nab-paclitaxel 80 mg/m^2
Nab-paclitaxel is administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Date of first dose until PD or death, up to 18 months
To evaluate PFS as the time from enrollment until first documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by the Investigator, or death due to any cause, whichever occurs first.
Date of first dose until PD or death, up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Date of first dose until PD or death, up to 18 months
To evaluate the proportion of patients with measurable disease at Baseline who attain complete response (CR) or partial response (PR) by RECIST version 1.1.
Date of first dose until PD or death, up to 18 months
Overall Survival (OS)
Time Frame: Date of first dose up to 6, 12, and 18 months
To evaluate the probability of OS survival at 6, 12, and 18 months.
Date of first dose up to 6, 12, and 18 months
Number of patients with one or more adverse events
Time Frame: Date of first dose up to 30 days after last dose
Date of first dose up to 30 days after last dose
Duration of Response (DOR)
Time Frame: Time of first objective response until PD or death, up to 18 months
To evaluate DOR as the time from the first CR or PR to first objectively documented PD or death, whichever comes first.
Time of first objective response until PD or death, up to 18 months
Clinical Benefit Rate (CBR)
Time Frame: Week 24
To evaluate CBR as the proportion of patients who attain CR, PR, or stable disease (SD) at Week 24 as per RECIST version 1.1.
Week 24
Best Overall Response Rate (BOR)
Time Frame: Date of first dose until PD or death, up to 18 months
To evaluate the BOR by RECIST version 1.1 recorded from the date of enrollment until PD or death.
Date of first dose until PD or death, up to 18 months
Area under the plasma concentration-time curve (AUC) of relacorilant
Time Frame: On Cycle 1 Day 8 (each cycle is 28 days)
To estimate exposure of relacorilant. This outcome applies to Arms B and C only.
On Cycle 1 Day 8 (each cycle is 28 days)
Maximum plasma concentration (Cmax) of relacorilant
Time Frame: On Cycle1 Day 8 (each cycle is 28 days)
To estimate exposure of relacorilant. This outcome applies to Arms B and C only.
On Cycle1 Day 8 (each cycle is 28 days)
Trough plasma concentrations (Cmin) of relacorilant
Time Frame: On Cycle 2 Day 8 through the last cycle (up to 12 cycles, each cycle is 28 days)
To estimate exposure of relacorilant. This outcome applies to Arms B and C only.
On Cycle 2 Day 8 through the last cycle (up to 12 cycles, each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corcept Therapeutics

Investigators

  • Study Director: Sachin Pai, MD, MS, Corcept Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORT125134-557

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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