Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma

April 21, 2026 updated by: Corcept Therapeutics

A Phase 2, Single-Arm Trial of Relacorilant in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma (TRIDENT)

This is a Phase 2, single-arm study to evaluate the safety and efficacy of relacorilant in combination with nab-paclitaxel and gemcitabine in patients with previously untreated metastatic pancreatic adenocarcinoma (PDAC).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study treatment will be comprised of relacorilant, combined with nab-paclitaxel and gemcitabine. Each patient will receive relacorilant 150 mg administered orally under fed conditions, once daily for 3 consecutive days on the day before (excluding Cycle 1 Day -1), the day of, and the day after nab-paclitaxel (100 mg/m^2) and gemcitabine (1000 mg/m^2) infusions. Nab-paclitaxel and gemcitabine will be administered on Days 1, 8, and 15 of each 28-day cycle. Patients will receive study treatment until they reach progressive disease (PD), experience unmanageable toxicity, or until other discontinuation criteria are met.

Study Type

Interventional

Enrollment (Estimated)

60

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

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • Site 02
    • California
      • Los Angeles, California, United States, 90025
        • Recruiting
        • Site 04
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Site 06
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Site 03
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Recruiting
        • Site 10
    • New York
      • Albany, New York, United States, 12206
        • Recruiting
        • Site 08
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Site 05
      • Shirley, New York, United States, 11967
        • Recruiting
        • Site 07
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Site 09
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Site 01

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:

  • Signed and dated informed consent form prior to screening procedures
  • Histologic diagnosis or cytologic diagnosis of pancreatic adenocarcinoma (PDAC)
  • Initial diagnosis of metastatic disease occurred ≤6 weeks prior to enrollment in the study
  • Life expectancy of ≥3 months
  • Radiographic confirmation of metastatic disease with at least 1 distant tumor metastasis measurable on radiology imaging per RECIST version 1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Able to provide informed consent and comply with protocol requirements
  • Able to swallow and retain oral medication and does not have uncontrolled emesis
  • Has adequate gastrointestinal absorption
  • Received no prior systemic anticancer therapy to treat metastatic disease
  • If a patient received prior treatment of PDAC with chemotherapy, disease progression must have occurred >12 months after completing the last dose, and no persistent treatment-related toxicities can be present.
  • Adequate organ function
  • Negative pregnancy test for patients of childbearing potential
  • Agree to use protocol defined precautions to avoid pregnancy

Exclusion Criteria:

  • Any major surgery within 4 weeks prior to enrollment

  • Prior treatment as follows:

    1. Radiotherapy, surgery, chemotherapy, immunotherapy, investigational therapy for the treatment of metastatic disease
    2. Systemic, inhaled, or prescription strength topical corticosteroids within 5 times the half-life of the corticosteroid used prior to first dose of study drug
  • Received gemcitabine or nab-paclitaxel to treat their PDAC
  • Known germline or somatic breast cancer gene (BRCA) mutation
  • Peripheral neuropathy from any cause >Grade 1
  • Medical conditions requiring chronic or frequent treatment with corticosteroids
  • History of severe hypersensitivity or severe reaction to any of study drugs or their excipients
  • Concurrent treatment with mifepristone or other glucocorticoid receptor modulators.
  • Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation
  • Active infection with HIV, hepatitis C or hepatitis B virus
  • Known untreated parenchymal brain metastasis or uncontrolled central nervous system metastases
  • History of other malignancy within 3 years prior to enrollment
  • Taking protocol-prohibited medications
  • Concurrent treatment with other investigational treatment studies for cancer
  • Has received a live vaccine within 30 days prior to the study start date

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Relacorilant in Combination with Nab-paclitaxel and Gemcitabine
The patient will receive relacorilant 150 mg, administered orally under fed conditions, once daily for 3 consecutive days on the day before (excluding Cycle 1, day -1), the day of, and the day after nab-paclitaxel and gemcitabine infusions. Nab-paclitaxel (100 mg/m^2) and gemcitabine (1000 mg/m^2) will be administered by IV infusion on Days 1, 8, and 15 of each 28-day cycle. On days when relacorilant, nab-paclitaxel, and gemcitabine are administered, relacorilant will be administered first, then nab-paclitaxel, and gemcitabine last.
Drug: Relacorilant 150 mg once daily (QD)
Relacorilant will be administered as capsules for oral dosing on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel and gemcitabine infusions.
Other Names:
  • CORT125134
Drug: Nab-paclitaxel 100 mg/m^2
Nab-paclitaxel will be administered via intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle.
Drug: Gemcitabine 1000 mg/m^2
Gemcitabine will be administered via intravenous (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: From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 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 comes first.
From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Benefit Rate (CBR)
Time Frame: Week 24
To evaluate clinical benefit rate as the proportion of patients who attain CR, PR, or stable disease (SD) at Week 24 as per RECIST version 1.1.
Week 24
Overall Survival (OS)
Time Frame: From date of enrollment until the date of death from any cause, whichever comes first, assessed up to 19 months
From date of enrollment until the date of death from any cause, whichever comes first, assessed up to 19 months
Best Overall Response (BOR)
Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months
From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months
Objective Response Rate (ORR)
Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 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.
From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months
Duration of Response (DoR)
Time Frame: From date of first objective response until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months
To evaluate DOR as the time from the first CR or PR to first documented PD or death, whichever comes first.
From date of first objective response until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months
Number of Patients with 1 or More Adverse Events
Time Frame: Time of first dose up to 30 days after last dose
Time of first dose up to 30 days after last dose
Maximum Plasma Concentration (Cmax) of Relacorilant
Time Frame: Pre- and postdose on Cycle 1 Day 8 (each cycle is 28 days)
Pre- and postdose on Cycle 1 Day 8 (each cycle is 28 days)
Area Under the Plasma Concentration-time Curve (AUC) of Relacorilant
Time Frame: Pre- and postdose on Cycle 1 Day 8 (each cycle is 28 days)
Pre- and postdose on Cycle 1 Day 8 (each cycle is 28 days)
Cmax of Nab-paclitaxel
Time Frame: Postdose on Cycle 1 Day 8 (each cycle is 28 days)
Postdose on Cycle 1 Day 8 (each cycle is 28 days)
AUC of Nab-paclitaxel
Time Frame: Postdose on Cycle 1 Day 8 (each cycle is 28 days)
Postdose on Cycle 1 Day 8 (each cycle is 28 days)
Cancer Antigen 19-9 (CA19-9) Kinetics
Time Frame: Baseline to Weeks 4, 8, and 16
To evaluate change in CA19-9 from baseline in patients who had an elevated baseline CA19-9 and change in CA19-9 at Weeks 4, 8, and 16 from baseline in all patients.
Baseline to Weeks 4, 8, and 16

Collaborators and Investigators

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

Sponsor

Corcept Therapeutics

Investigators

  • Study Director: Sachin Pai, 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)

January 27, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

November 3, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORT125134-558

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

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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