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

NCT07259317 | Recruiting Phase 2 FDA Drug

• 1 other identifier: CORT125134-558
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 15

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

Keywords

Pancreatic; Adenocarcinoma; PDAC; Pancreas

Outcome Measures

Primary Outcomes (3)

• 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.

  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)

  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 Outcomes (14)

• Maximum Plasma Concentration (Cmax) of Relacorilant (Part 1 and Part 2)

  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)

  Pre- and postdose on Cycle 1 Day 15 (each cycle is 28 days)

• Cmax of Nab-paclitaxel (Part 1 and Part 2)

  At serial timepoints postdose on Cycle 1 Day 15 (each cycle is 28 days)

• AUC of Nab-paclitaxel (Part 1 and Part 2)

  At serial timepoints postdose on Cycle 1 Day 15 (each cycle is 28 days)

• Overall Survival (OS) (Part 2)

  From date of enrollment until the date of death from any cause, whichever comes first, assessed up to 19 months

Study Arms (1)

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.

Drug: Relacorilant; Drug: Nab-paclitaxel; Drug: Gemcitabine

Interventions

Relacorilant DRUG

Relacorilant will be administered as capsules for oral dosing.

Also known as: CORT125134

Relacorilant in Combination with Nab-paclitaxel and Gemcitabine

Nab-paclitaxel DRUG

Nab-paclitaxel will be administered via IV infusion.

Relacorilant in Combination with Nab-paclitaxel and Gemcitabine

Gemcitabine DRUG

Gemcitabine will be administered via IV infusion.

Relacorilant in Combination with Nab-paclitaxel and Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (15)

Site 02

Scottsdale, Arizona, 85258, United States

RECRUITING

Site 04

Los Angeles, California, 90025, United States

RECRUITING

Site 12

Orange, California, 92868, United States

RECRUITING

Site 06

Atlanta, Georgia, 30322, United States

RECRUITING

Site 14

Goshen, Indiana, 46526, United States

RECRUITING

Site 15

Westwood, Kansas, 66205, United States

RECRUITING

Site 03

Grand Rapids, Michigan, 49503, United States

RECRUITING

Site 10

East Brunswick, New Jersey, 08816, United States

RECRUITING

Site 11

Morristown, New Jersey, 07960, United States

RECRUITING

Site 08

Albany, New York, 12206, United States

RECRUITING

Site 05

Lake Success, New York, 11042, United States

WITHDRAWN

Site 07

Shirley, New York, 11967, United States

RECRUITING

Site 13

Cincinnati, Ohio, 45219, United States

RECRUITING

Site 09

Nashville, Tennessee, 37203, United States

RECRUITING

Site 01

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma; Carcinoma, Pancreatic Ductal

Interventions

relacorilant; 130-nm albumin-bound paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Ductal; Neoplasms, Ductal, Lobular, and Medullary; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Adrian Jubb

  Corcept Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Corcept Therapeutics

CONTACT

(650) 815-1595; corceptstudy558@corcept.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: December 2, 2025
• Study Start: January 27, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)