MK2 Inhibitor in Combination With mFOLFIRINOX for Untreated Metastatic Pancreatic Ductal Adenocar… (NCT06648434) | Clinical Trial Compass
RecruitingPhase 1
MK2 Inhibitor in Combination With mFOLFIRINOX for Untreated Metastatic Pancreatic Ductal Adenocarcinoma
United States51 participantsStarted 2025-06-13
Plain-language summary
The investigators hypothesize that MK2 inhibition may improve efficacy of mFOLFIRINOX chemotherapy for patients with pancreatic ductal adenocarcinoma (PDAC).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 po…
What they're measuring
1
Recommended phase II dose (RP2D) of zunsemetinib in combination with mFOLFIRINOX (Dose Escalation Only)
Timeframe: Completion of 2 cycles (each cycle is 2 weeks - estimated to be 4 weeks)
2
Number of participants with dose-limiting toxicities (DLTs) (Dose Escalation only)
Timeframe: Completion of 2 cycles (each cycle is 2 weeks - estimated to be 4 weeks)