Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
Start Date
1/27/2026
Completion Date
9/1/2027
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).
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Relacorilant
Nab-paclitaxel
Gemcitabine
Conditions
Locations
Site 02
Scottsdale, Arizona 85258
United States
Site 04
Los Angeles, California 90025
United States
Site 12
Orange, California 92868
United States
Site 06
Atlanta, Georgia 30322
United States
Site 14
Goshen, Indiana 46526
United States
Site 15
Westwood, Kansas 66205
United States
Site 03
Grand Rapids, Michigan 49503
United States
Site 10
East Brunswick, New Jersey 08816
United States
Site 11
Morristown, New Jersey 07960
United States
Site 08
Albany, New York 12206
United States
Site 05
Lake Success, New York 11042
United States
Site 07
Shirley, New York 11967
United States
Site 13
Cincinnati, Ohio 45219
United States
Site 09
Nashville, Tennessee 37203
United States
Site 01
San Antonio, Texas 78229
United States