Recruiting
Phase 2

Relacorilant, Nab-Paclitaxel, Gemcitabine

Sponsor:

Corcept Therapeutics

Code:

NCT07259317

Conditions

Adenocarcinoma

Carcinoma, Pancreatic Ductal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Relacorilant

Nab-paclitaxel

Gemcitabine

Study Details

Brief 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).

Conditions

Adenocarcinoma

Carcinoma, Pancreatic Ductal

Study ID

NCT07259317

Start date

Jan 27, 2026

Status verified date

Aug, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

80 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Relacorilant in Combination with Nab-paclitaxel and Gemcitabine

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.

Interventions

Relacorilant

Relacorilant will be administered as capsules for oral dosing.

Nab-paclitaxel

Nab-paclitaxel will be administered via IV infusion.

Gemcitabine

Gemcitabine will be administered via IV infusion.

Primary outcome measure

  • Percent of Patients who Experience Dose Limiting Toxicity (DLT) (Part 1) [ Time Frame: 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 Frame: Time of first dose up to 30 days after last dose ]
  • Progression-Free Survival (PFS) (Part 2) [ 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 ]

Central Contacts and Locations

Central contacts

Corcept Therapeutics

(650) 815-1595corceptstudy558@corcept.com

Locations

Site 02

Recruiting

Scottsdale, Arizona, United States, 85258

Site 04

Recruiting

Los Angeles, California, United States, 90025

Site 12

Recruiting

Orange, California, United States, 92868

Site 06

Recruiting

Atlanta, Georgia, United States, 30322

Site 14

Recruiting

Goshen, Indiana, United States, 46526

Site 15

Recruiting

Westwood, Kansas, United States, 66205

Site 03

Recruiting

Grand Rapids, Michigan, United States, 49503

Site 10

Recruiting

East Brunswick, New Jersey, United States, 08816

Site 11

Recruiting

Morristown, New Jersey, United States, 07960

Site 08

Recruiting

Albany, New York, United States, 12206

Site 07

Recruiting

Shirley, New York, United States, 11967

Site 13

Recruiting

Cincinnati, Ohio, United States, 45219

Site 09

Recruiting

Nashville, Tennessee, United States, 37203

Site 16

Recruiting

Fort Worth, Texas, United States, 76104

Site 01

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

Corcept Therapeutics

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • Pancreatic
  • Adenocarcinoma
  • PDAC
  • Pancreas

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Corcept Therapeutics on 2026-08-18.