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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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

You cannot join if

• 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
• 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

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

relacorilant. An orally available antagonist of the glucocorticoid receptor (GR), with potential antineoplastic activity. Upon administration, relacorilant competitively binds to and blocks GRs. This inhibits the activity of GRs, and prevents both the translocation of the ligand-GR complexes to the nucleus and gene expression of GR-associated genes. This decreases the negative effects that result from excess levels of endogenous glucocorticoids, like those seen when tumors overproduce glucocorticoids. In addition, by binding to GRs and preventing their activity, inhibition with CORT125134 also inhibits the proliferation of GR-overexpressing cancer cells. GRs are overexpressed in certain tumor cell types and promote tumor cell proliferation. NCI Drug Dictionary

Treatments listed in the registry

• Relacorilant (Drug): Relacorilant will be administered as capsules for oral dosing.
• Nab-paclitaxel (Drug): Nab-paclitaxel will be administered via IV infusion.
• Gemcitabine (Drug): Gemcitabine will be administered via IV infusion.

Na · Sequential · masking: None

Main goals

• 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)

Other goals

• Maximum Plasma Concentration (Cmax) of Relacorilant (Part 1 and Part 2)
• Area Under the Plasma Concentration-time Curve (AUC) of Relacorilant (Part 1 and Part 2)
• Cmax of Nab-paclitaxel (Part 1 and Part 2)
• AUC of Nab-paclitaxel (Part 1 and Part 2)
• Overall Survival (OS) (Part 2)
• Best Overall Response (BOR) (Part 2)
• Objective Response Rate (ORR) (Part 2)
• Duration of Response (DoR) (Part 2)
• Clinical Benefit Rate (CBR) (Part 2)
• Cancer Antigen 19-9 (CA19-9) Kinetics (Part 2)
• Number of Patients with 1 or More Adverse Events (Part 2)
• Number of Patients with Treatment-related Adverse Events (Part 2)
• Number of Patients with Adverse Events by Severity (Part 2)
• Number of Patients With 1 or More Adverse Events Leading to Study Drug Discontinuation (Part 2)

Planned enrollment: 80 (estimated).

• Site 02, Scottsdale, Arizona
• Site 04, Los Angeles, California
• Site 12, Orange, California
• Site 17, Jacksonville, Florida
• Site 06, Atlanta, Georgia
• Site 14, Goshen, Indiana
• Site 15, Westwood, Kansas
• Site 03, Grand Rapids, Michigan
• Site 18, Rochester, Minnesota
• Site 10, East Brunswick, New Jersey
• Site 11, Morristown, New Jersey
• Site 08, Albany, New York
• Site 07, Shirley, New York
• Site 13, Cincinnati, Ohio
• Site 20, Toledo, Ohio
• Site 09, Nashville, Tennessee
• Site 19, Nashville, Tennessee
• Site 16, Fort Worth, Texas
• Site 01, San Antonio, Texas

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07259317
• NCI Drug Dictionary: C127838

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 24, 2026. Public record; not medical advice.