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OncoMatch/Clinical Trials/NCT06648434

MK2 Inhibitor in Combination With mFOLFIRINOX for Untreated Metastatic Pancreatic Ductal Adenocarcinoma

Is NCT06648434 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Zunsemetinib and mFOLFIRINOX for metastatic pancreatic ductal adenocarcinoma.

Phase 1RecruitingWashington University School of MedicineNCT06648434Data as of May 2026

Treatment: Zunsemetinib · mFOLFIRINOXThe investigators hypothesize that MK2 inhibition may improve efficacy of mFOLFIRINOX chemotherapy for patients with pancreatic ductal adenocarcinoma (PDAC).

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Extracted eligibility criteria

Cancer type

Pancreatic Cancer

Disease stage

Required: Stage IV

Diagnosis of advanced inoperable or metastatic disease, where mFOLFIRINOX (or classical FOLFIRINOX) is deemed a suitable option per the treating physician. Measurable disease by RECIST 1.1.

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic therapy

Exception: Prior adjuvant/neoadjuvant therapy (including FOLFIRINOX or mFOLFIRINOX regimens) is allowed if progression occurred ≥ 12 months from the last dose of that therapy.

no prior systemic treatment for advanced or metastatic disease. Prior adjuvant/neoadjuvant therapy (including FOLFIRINOX or mFOLFIRINOX regimens) is allowed if progression occurred ≥ 12 months from the last dose of that therapy.

Lab requirements

Blood counts

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

Kidney function

Creatinine clearance > 50 mL/min by Cockcroft-Gault

Liver function

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

Cardiac function

Baseline EKG with QTcF ≤ 460 ms

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.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Washington University School of Medicine · St Louis, Missouri

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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