Actively Recruiting
Phase I Trial of MK2 Inhibitor Zunsemetinib Combined With mFOLFIRINOX Chemotherapy for Untreated Metastatic Pancreatic Ductal Adenocarcinoma
Led by Washington University School of Medicine · Updated on 2026-04-30
51
Participants Needed
1
Research Sites
152 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
Researchers are evaluating whether inhibiting MK2 can improve the effectiveness of mFOLFIRINOX chemotherapy in patients with untreated metastatic pancreatic ductal adenocarcinoma (PDAC). This Phase I trial focuses on determining the right dose of the MK2 inhibitor, zunsemetinib, combined with mFOLFIRINOX, a chemotherapy regimen including oxaliplatin, irinotecan, leucovorin, and 5-FU. Participants receive zunsemetinib orally once or twice daily depending on the dose level assigned during the dose escalation phase. The chemotherapy mFOLFIRINOX is given intravenously every two weeks in cycles consisting of oxaliplatin, irinotecan, leucovorin, and a continuous infusion of 5-FU over 46 hours. The trial includes a dose escalation phase to find the recommended Phase II dose followed by a dose expansion phase to further evaluate this combination treatment. During the study, participants are monitored for dose-limiting toxicities and adverse events. Researchers measure treatment responses such as progression-free survival, overall survival, disease control, and tumor marker changes over time. Blood samples are collected to study drug levels and metabolites. The study involves regular assessments over approximately 12 months of treatment and up to 3 years of follow-up to track long-term outcomes and safety.
CONDITIONS
Brief 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
- Mixed tumor types allowed if adenocarcinoma is predominant
- Prior adjuvant/neoadjuvant therapy allowed if progression occurred 12 months or more after last dose
- Diagnosis of advanced inoperable or metastatic disease suitable for mFOLFIRINOX treatment
- Measurable disease by RECIST 1.1
- At least 18 years old
- ECOG performance status of 0 or 1
- Adequate bone marrow and organ function including neutrophils ≥1.5 K/cumm, platelets ≥100 K/cumm, hemoglobin ≥9.0 g/dL, bilirubin ≤1.5 x upper limit of normal, AST/ALT ≤3.0 x upper limit of normal (or ≤5.0 with liver metastases), creatinine clearance >50 mL/min
- Baseline EKG with QTcF ≤460 ms
- Agreement to use adequate contraception if of childbearing potential
- Ability to understand and sign informed consent
You will not qualify if you...
- History of other cancers unless treated over 2 years ago or indolent and not affecting pancreatic cancer treatment
- History of allogeneic organ or stem cell transplant
- Receiving other investigational agents or within 2 weeks or 5 half-lives of prior investigational agent
- Use of certain CYP3A4 and CYP2C8 inhibitors, inducers, or QT prolonging drugs prior to treatment
- Known brain metastases or central nervous system involvement
- Allergic reactions to compounds similar to study drugs
- Clinically significant neuropathy grade 2 or higher
- Symptomatic interstitial lung disease
- Gastrointestinal conditions preventing absorption of oral study drug
- Inability to swallow pills
- Uncontrolled illnesses such as infection, heart failure, unstable angina, or arrhythmia
- Pregnant or breastfeeding women; must have negative pregnancy test if of childbearing potential
- HIV patients with low CD4 counts or recent AIDS-defining infections
- Major surgery within 28 days before starting treatment
- Use of live vaccines within 4 weeks before treatment start
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive the MK2 inhibitor Zunsemetinib orally daily in combination with mFOLFIRINOX chemotherapy administered intravenously in 2-week cycles. Treatment continues through multiple cycles based on individual response and tolerance.
Biweekly visits for treatment administration and assessments
Duration - Up to 3 years
Participants are monitored for safety and survival outcomes after completing treatment, including assessments for adverse events and disease progression.
Periodic visits during follow-up
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.
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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