AdenocarcinomaPhase 2NCT07259317
Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
A Phase 2 study testing Relacorilant, Nab-paclitaxel and Gemcitabine in people with Adenocarcinoma and Carcinoma, Pancreatic Ductal, run by Corcept Therapeutics at 20 sites in United States.
Trial summary
This is a 2-part, Phase 2 study to evaluate the safety, tolerability, dosing, pharmacokinetics (PK), and efficacy of relacorilant in combination with nab-paclitaxel and gemcitabine in chemotherapy-naïve patients with metastatic pancreatic adenocarcinoma (PDAC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma, Carcinoma, Pancreatic Ductal
- What is being tested?
- Relacorilant, Nab-paclitaxel and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 20 sitesUnited States
- Study dates
- 27 Jan 2026to Sep 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ≤9 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
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- 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 chemotherapy to treat metastatic PDAC. Treatment of PDAC with a single agent RAS inhibitor is permitted.
- 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
Who cannot join
- Any major surgery within 4 weeks prior to enrollment
- Prior treatment as follows:
- Radiotherapy, surgery, chemotherapy, immunotherapy, investigational therapy for the treatment of metastatic disease
- 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
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- 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
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
United States20 sites, 19 recruiting
- Recruiting
Site 08
Albany, New York, 12206
- Recruiting
Site 06
Atlanta, Georgia, 30322
- Recruiting
Site 13
Cincinnati, Ohio, 45219
- Recruiting
Site 10
East Brunswick, New Jersey, 08816
- Recruiting
Site 16
Fort Worth, Texas, 76104
- Recruiting
Site 14
Goshen, Indiana, 46526
- Recruiting
Site 03
Grand Rapids, Michigan, 49503
- Recruiting
Site 17
Jacksonville, Florida, 32224
- Withdrawn
Site 05
Lake Success, New York, 11042
- Recruiting
Site 04
Los Angeles, California, 90025
- Recruiting
Site 11
Morristown, New Jersey, 07960
- Recruiting
Site 09
Nashville, Tennessee, 37203
- Recruiting
Site 19
Nashville, Tennessee, 37232
- Recruiting
Site 12
Orange, California, 92868
- Recruiting
Site 18
Rochester, Minnesota, 55905
- Recruiting
Site 01
San Antonio, Texas, 78229
- Recruiting
Site 02
Scottsdale, Arizona, 85258
- Recruiting
Site 07
Shirley, New York, 11967
- Recruiting
Site 20
Toledo, Ohio, 43614
- Recruiting
Site 15
Westwood, Kansas, 66205
About this study
Official title: A Phase 2, Single-Arm Trial of Relacorilant in Combination With Nab-Paclitaxel and Gemcitabine in Chemotherapy-Naïve Patients With Metastatic Pancreatic Adenocarcinoma (TRIDENT)
This is a 2-part, Phase 2 study to evaluate the safety, tolerability, dosing, pharmacokinetics (PK), and efficacy of relacorilant in combination with nab-paclitaxel and gemcitabine in chemotherapy-naïve patients with metastatic pancreatic adenocarcinoma (PDAC).
Read the detailed description
This study will include 2 parts. In Part 1 (dose finding), approximately 6 patients will be enrolled to individual dose-finding cohorts. Cohorts will receive various dose concentrations of relacorilant, nab-paclitaxel, and gemcitabine at various dosing schedules. In all dose-finding cohorts, relacorilant will be administered orally under fed conditions, once daily for 3 days on the day before (excluding Cycle 1 Day -1), the day of, and the day after nab-paclitaxel and gemcitabine. Enrollment will be paused after each cohort has been filled until the safety review committee (SRC) provides recommendations. If maximum tolerated dose (MTD) criteria are not met in a cohort, then either a dose-finding cohort at a more intense dose and/or schedule may be enrolled, or a dose and schedule at/below the MTD may be selected as the optimal dose and schedule, and Part 2 may be initiated. If MTD criteria are met, then a dose-finding cohort at a less intense dose and/or schedule may be enrolled, or dose-finding may end without proceeding to Part 2.
In Part 2 (expansion), each patient will receive the optimal dose and schedule of relacorilant, nab-paclitaxel, and gemcitabine as identified in Part 1. Analysis of Part 2 will include data for patients from Part 1 who were enrolled in the optimal dose and schedule used in Part 2.
- Conditions
- Adenocarcinoma, Carcinoma, Pancreatic Ductal
- Being tested
- Relacorilant, Nab-paclitaxel, Gemcitabine
- Keywords
- Pancreatic, Adenocarcinoma, PDAC, Pancreas
- Medical subject headings
- Adenocarcinoma, Carcinoma, Pancreatic Ductal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RelacorilantDrug
Also called CORT125134
Relacorilant will be administered as capsules for oral dosing.
Nab-paclitaxelDrug
Nab-paclitaxel will be administered via IV infusion.
GemcitabineDrug
Gemcitabine will be administered via IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Relacorilant in Combination with Nab-paclitaxel and Gemcitabine | Experimental | The patient will receive relacorilant 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 intravenous (IV) infusions. Various dose levels and dosing schedules of relacorilant, nab-paclitaxel, and gemcitabine will be evaluated. On days when relacorilant, nab-paclitaxel, and gemcitabine are administered, relacorilant will be administered first, then nab-paclitaxel, and gemcitabine last. Receives: Drug: Relacorilant; Drug: Nab-paclitaxel; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Patients who Experience Dose Limiting Toxicity (DLT) (Part 1)
The percentage of patients with a DLT is used to estimate maximum tolerated dose (MTD), the most intense dose/schedule among those evaluated at which <33% of patients experience DLT.
Measured: Up to 28 days after the first dose of study treatment
Number of Patients with 1 or More Adverse Events (AEs) Leading to Study Drug Discontinuations or Dose Modifications (Part 1)
Measured: Time of first dose up to 30 days after last dose
Progression-Free Survival (PFS) (Part 2)
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.
Measured: 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 outcomes (14)
Maximum Plasma Concentration (Cmax) of Relacorilant (Part 1 and Part 2)
Measured: Pre- and postdose on Cycle 1 Day 15 (each cycle is 28 days)
Area Under the Plasma Concentration-time Curve (AUC) of Relacorilant (Part 1 and Part 2)
Measured: Pre- and postdose on Cycle 1 Day 15 (each cycle is 28 days)
Cmax of Nab-paclitaxel (Part 1 and Part 2)
Measured: At serial timepoints postdose on Cycle 1 Day 15 (each cycle is 28 days)
AUC of Nab-paclitaxel (Part 1 and Part 2)
Measured: At serial timepoints postdose on Cycle 1 Day 15 (each cycle is 28 days)
Overall Survival (OS) (Part 2)
Measured: From date of enrollment until the date of death from any cause, whichever comes first, assessed up to 19 months
Best Overall Response (BOR) (Part 2)
Measured: 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) (Part 2)
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.
Measured: 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) (Part 2)
To evaluate DOR as the time from the first CR or PR to first documented PD or death, whichever comes first.
Measured: 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
Clinical Benefit Rate (CBR) (Part 2)
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.
Measured: Week 24
Cancer Antigen 19-9 (CA19-9) Kinetics (Part 2)
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.
Measured: Baseline to Weeks 4, 8, and 16
Number of Patients with 1 or More Adverse Events (Part 2)
Measured: Time of first dose up to 30 days after last dose
Number of Patients with Treatment-related Adverse Events (Part 2)
Measured: Time of first dose up to 30 days after last dose
Number of Patients with Adverse Events by Severity (Part 2)
Measured: Time of first dose up to 30 days after last dose
Number of Patients With 1 or More Adverse Events Leading to Study Drug Discontinuation (Part 2)
Measured: Time of first dose up to 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start27 Jan 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Danny Nguyen, Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259317
- Sponsor's protocol ID
- CORT125134-558
- Status last verified
- Sep 2026
- First submitted
- 3 Nov 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No