MK2 Inhibitor with mFOLFIRINOX for Metastatic Pancreatic Cancer
This study is testing a new combination treatment for metastatic pancreatic ductal adenocarcinoma (a type of pancreatic cancer that has spread). It combines zunsemetinib, a drug taken by mouth, with mFOLFIRINOX chemotherapy (which includes oxaliplatin, irinotecan, leucovorin, and 5-FU). Researchers believe that zunsemetinib might make mFOLFIRINOX more effective. This study is looking to find the best dose of zunsemetinib to use with mFOLFIRINOX and to see how many participants experience side effects. You may be able to join if you have pancreatic ductal adenocarcinoma that has spread and you haven't had prior treatment for your advanced cancer. The study plans to enroll 51 participants, but its current status is unclear.
- Study design
- This is an interventional study planning to enroll 51 participants. The phase of the study is not specified.
- What's involved
- You would take zunsemetinib daily, either once or twice, about 12 or 24 hours apart, with water. You would also receive mFOLFIRINOX chemotherapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for dose and side effects are measured at the completion of 2 cycles, which is estimated to be 4 weeks.
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NCT06648434
MK2 Inhibitor in Combination With mFOLFIRINOX for Untreated Metastatic Pancreatic Ductal Adenocarcinoma
Recruiting
PHASE1Ages 18+InterventionalTreatmentWashington University School of MedicineInvestigator-initiated
~51 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:ZunsemetinibmFOLFIRINOX
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended phase II dose (RP2D) of zunsemetinib in combination with mFOLFIRINOX (Dose Escalation Only)
Measured over Completion of 2 cycles (each cycle is 2 weeks - estimated to be 4 weeks)
+1 more outcome measured
Conditions
NCT06648434
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Washington University School of Medicine
St Louis, Missouristudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Moh'd Khushman, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
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Eligibility criteria
Inclusion
Histologically or cytologically confirmed pancreatic ductal adenocarcinoma with no prior systemic treatment for advanced or metastatic disease. Patients with mixed cytology in their tumors such as adeno-squamous, mixed neuroendocrine-carcinoma are permitted if the portion of adenocarcinoma is predominant. Prior adjuvant/neoadjuvant therapy (including FOLFIRINOX or mFOLFIRINOX regimens) is allowed if progression occurred ≥ 12 months from the last dose of that therapy. A biopsy is not required to confirm advanced or metastatic disease.
Dose escalation: Diagnosis of advanced inoperable or metastatic disease, where mFOLFIRINOX (or classical FOLFIRINOX) is deemed a suitable option per the treating physician.
Dose expansion: Diagnosis of metastatic disease, where mFOLFIRINOX (or classical FOLFIRINOX) is deemed a suitable option per the treating physician.
Measurable disease by RECIST 1.1.
At least 18 years of age
ECOG performance status ≤ 1.
Adequate bone marrow and organ function as defined below:
Absolute neutrophil count ≥ 1.5 K/cumm
Platelets ≥ 100 K/cumm without transfusion within 2 weeks prior to C1D1
Hemoglobin ≥ 9.0 g/dL without transfusion within 2 weeks prior to C1D1
Total bilirubin ≤ 1.5 x IULN
AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN, unless there are liver metastases in which case AST and ALT ≤ 5.0 x IULN
Creatinine clearance \> 50 mL/min by Cockcroft-Gault
Baseline EKG with QTcF ≤ 460 ms.
Women of childbearing potential and men who are heterosexually active must agree to use adequate contraception as specified in the protocol. Contraception should continue for 1 month following last dose of zunsemetinib, 6 months following last dose of irinotecan, 9 months following last dose of oxaliplatin, and/or 3 months following last dose of fluorouracil. Should a woman (or the female partner of a male participant) become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion
A history of other malignancy with the exception of 1) malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease; 2) or known indolent malignancies that do not require treatment and will likely not alter the course of treatment of metastatic pancreatic cancer.
History of allogeneic organ or stem cell transplant.
Currently receiving any other investigational agents, or receipt of an investigational agent within 2 weeks or 5 half-lives of the agent, whichever is shorter.
Receipt of strong and moderate CYP3A4 and CYP2C8 inhibitors (including grapefruit), strong and moderate CYP3A and CYP2C8 inducers (see Appendices H and I), and drugs with QT prolonging potential within 5 half-lives of cycle 1 day 1.
Known brain metastases or CNS involvement, because brain metastases are often associated with poor functional status, shortened life expectancy and risk of toxicity.
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to zunsemetinib, or other agents used in the study.
Clinically significant neuropathy ≥ grade 2.
Presence of interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity.
Gastrointestinal conditions which could prevent absorption of zunsemetinib, in the opinion of the treating physician.
Inability to swallow pills.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia .
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 7 days of C1D1.
Patients with HIV are eligible unless their CD4+ T-cell counts are \< 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.
Major surgery within 28 days prior to C1D1. Major surgery refers to any surgical procedure that involves general or regional anesthesia, involves extensive resecting or altering of body parts, carries a higher risk of complications, or requires long recovery times. Central line placement is allowed.
Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of C1D1.
What this trial measures
- Recommended phase II dose (RP2D) of zunsemetinib in combination with mFOLFIRINOX (Dose Escalation Only)Completion of 2 cycles (each cycle is 2 weeks - estimated to be 4 weeks)
- Number of participants with dose-limiting toxicities (DLTs) (Dose Escalation only)Completion of 2 cycles (each cycle is 2 weeks - estimated to be 4 weeks)