RecruitingRecruiting
Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
NCT07259317 · Corcept Therapeutics
In plain English
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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)
About this study
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.
Eligibility criteria
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 ≤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
* 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
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 design
Enrollment target: 80 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-01-27
Estimated completion: 2027-09
Last updated: 2026-08-18
Interventions
Drug: RelacorilantDrug: Nab-paclitaxelDrug: Gemcitabine
Primary outcomes
- • Percent of Patients who Experience Dose Limiting Toxicity (DLT) (Part 1) (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) (Time of first dose up to 30 days after last dose)
- • Progression-Free Survival (PFS) (Part 2) (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)
Sponsor
Corcept Therapeutics · industry
Contacts & investigators
ContactCorcept Therapeutics · contact · corceptstudy558@corcept.com · (650) 815-1595
InvestigatorAdrian Jubb · study_director, Corcept Therapeutics
All locations (16)
Site 02Recruiting
Scottsdale, Arizona, United States
Site 04Recruiting
Los Angeles, California, United States
Site 12Recruiting
Orange, California, United States
Site 06Recruiting
Atlanta, Georgia, United States
Site 14Recruiting
Goshen, Indiana, United States
Site 15Recruiting
Westwood, Kansas, United States
Site 03Recruiting
Grand Rapids, Michigan, United States
Site 10Recruiting
East Brunswick, New Jersey, United States
Site 11Recruiting
Morristown, New Jersey, United States
Site 08Recruiting
Albany, New York, United States
Site 05Withdrawn
Lake Success, New York, United States
Site 07Recruiting
Shirley, New York, United States
Site 13Recruiting
Cincinnati, Ohio, United States
Site 09Recruiting
Nashville, Tennessee, United States
Site 16Recruiting
Fort Worth, Texas, United States
Site 01Recruiting
San Antonio, Texas, United States