Relacorilant with nab-paclitaxel and gemcitabine for metastatic pancreatic adenocarcinoma

A Phase 2, Single-Arm Trial of Relacorilant in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma (TRIDENT)

This trial tests whether adding relacorilant to standard chemotherapy (nab-paclitaxel plus gemcitabine) helps people with previously untreated metastatic pancreatic adenocarcinoma.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Corcept Therapeutics (industry)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 10 sites (Scottsdale, Arizona and 9 other locations)
• Trial ID: NCT07259317 on ClinicalTrials.gov

What this trial studies

This single-arm Phase 2 study combines oral relacorilant with standard nab-paclitaxel and gemcitabine chemotherapy given on a 28-day cycle. Relacorilant 150 mg is taken once daily for three consecutive days around each chemotherapy infusion, while nab-paclitaxel (100 mg/m2) and gemcitabine (1000 mg/m2) are given on Days 1, 8, and 15. Patients continue treatment until disease progression, unacceptable toxicity, or other protocol-defined discontinuation. The study is designed to characterize safety and anti-tumor activity in patients with previously untreated metastatic PDAC.

Who should consider this trial

Good fit: Ideal candidates are adults with previously untreated metastatic pancreatic adenocarcinoma who have measurable disease, ECOG performance status 0–1, adequate organ function, and can swallow oral medication.

Not a fit: Patients who have had recent systemic therapy for metastatic disease, have poor performance status (ECOG ≥2), or have uncontrolled medical issues are unlikely to benefit from this regimen.

Why it matters

Potential benefit: If successful, this combination could make chemotherapy more effective and delay disease progression for people with metastatic pancreatic cancer.

How similar studies have performed: Using glucocorticoid receptor modulators like relacorilant with chemotherapy is a relatively new and experimental approach with limited clinical data in pancreatic cancer.

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 ≤6 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 therapy to treat metastatic disease
* 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

Where this trial is running

Scottsdale, Arizona and 9 other locations

• Site 02 — Scottsdale, Arizona, United States (RECRUITING)
• Site 04 — Los Angeles, California, United States (RECRUITING)
• Site 06 — Atlanta, Georgia, United States (RECRUITING)
• Site 03 — Grand Rapids, Michigan, United States (RECRUITING)
• Site 10 — East Brunswick, New Jersey, United States (RECRUITING)
• Site 08 — Albany, New York, United States (RECRUITING)
• Site 05 — Lake Success, New York, United States (RECRUITING)
• Site 07 — Shirley, New York, United States (RECRUITING)
• Site 09 — Nashville, Tennessee, United States (RECRUITING)
• Site 01 — San Antonio, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Corcept Therapeutics

Conditions: Adenocarcinoma, Carcinoma, Pancreatic Ductal, Pancreatic, PDAC, Pancreas