Actively Recruiting
MK2 Inhibitor in Combination With mFOLFIRINOX for Untreated Metastatic Pancreatic Ductal Adenocarcinoma
Led by Washington University School of Medicine · Updated on 2026-04-30
51
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The investigators hypothesize that MK2 inhibition may improve efficacy of mFOLFIRINOX chemotherapy for patients with pancreatic ductal adenocarcinoma (PDAC).
CONDITIONS
Official Title
MK2 Inhibitor in Combination With mFOLFIRINOX for Untreated Metastatic Pancreatic Ductal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma with no prior systemic treatment for advanced or metastatic disease
- Patients with mixed tumor cytology permitted if adenocarcinoma is predominant
- Prior adjuvant or neoadjuvant therapy allowed if progression occurred 12 months or more after last dose
- Diagnosis of advanced inoperable or metastatic disease suitable for mFOLFIRINOX
- Measurable disease by RECIST 1.1
- Age 18 years or older
- ECOG performance status 0 or 1
- Adequate bone marrow and organ function including neutrophils ≥ 1.5 K/cumm, platelets ≥ 100 K/cumm, hemoglobin ≥ 9.0 g/dL, total bilirubin ≤ 1.5 x IULN, AST/ALT ≤ 3.0 x IULN or ≤ 5.0 x IULN if liver metastases present, creatinine clearance > 50 mL/min
- Baseline EKG with QTcF ≤ 460 ms
- Women of childbearing potential and men who are heterosexually active must use contraception as specified
- Ability to understand and sign informed consent
You will not qualify if you...
- History of other malignancies except those treated over 2 years ago with no evidence of disease or indolent malignancies not affecting treatment
- History of allogeneic organ or stem cell transplant
- Currently receiving or recently received other investigational agents
- Use of strong or moderate CYP3A4 and CYP2C8 inhibitors or inducers, or drugs prolonging QT interval within 5 half-lives before treatment
- Known brain metastases or central nervous system involvement
- Allergic reactions to similar compounds as study drugs
- Clinically significant neuropathy grade 2 or higher
- Symptomatic interstitial lung disease or conditions interfering with lung toxicity management
- Gastrointestinal conditions affecting drug absorption
- Inability to swallow pills
- Uncontrolled illness such as active infection, congestive heart failure, unstable angina, or cardiac arrhythmia
- Pregnant or breastfeeding women; women must have negative pregnancy test within 7 days before treatment
- HIV patients with CD4+ counts below 350 cells/mcL or recent AIDS-defining infections
- Major surgery within 28 days before treatment
- Use of live vaccines within 28 days before treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
M
Moh'd Khushman, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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