Clinical trial · Interventional
Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
A Phase 2, Single-Arm Trial of Relacorilant in Combination With Nab-Paclitaxel and Gemcitabine in Chemotherapy-Naïve Patients With Metastatic Pancreatic Adenocarcinoma (TRIDENT)
NCT07259317CI-TRIAL-00122468recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Carcinoma, Pancreatic Ductal | Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Relacorilant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Relacorilant in Combination with Nab-paclitaxel and Gemcitabine
- description
- 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.
- interventionNames
- Drug: Relacorilant
- Drug: Nab-paclitaxel
- Drug: Gemcitabine
Primary outcomes (3)
- measure
- Percent of Patients who Experience Dose Limiting Toxicity (DLT) (Part 1)
- timeFrame
- Up to 28 days after the first dose of study treatment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.