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

Study treatment will be comprised of relacorilant, combined with nab-paclitaxel and gemcitabine. Each patient will receive relacorilant 150 mg 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 (100 mg/m^2) and gemcitabine (1000 mg/m^2) infusions. Nab-paclitaxel and gemcitabine will be administered on Days 1, 8, and 15 of each 28-day cycle. Patients will receive study treatment until they reach progressive disease (PD), experience unmanageable toxicity, or until other discontinuation criteria are met.

Sex: ALL
Minimum Age: 18 Years
Healthy Volunteers: No
Age Groups: ADULT, OLDER_ADULT

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