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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 (Jun 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 Jun 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

Treatments studied

Targeted therapy

Zunsemetinib

Other

mFOLFIRINOX

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 →

Frequently asked questions

Is NCT06648434 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

What disease stage is eligible?

Stage IV is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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