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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06648434
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zunsemetinib — DRUG
    Patients should take zunsemetinib approximately 12 hours apart (if twice daily dosing) or 24 hours apart (if once daily dosing) at the same time(s) every day, with 8 oz of water.
  • mFOLFIRINOX — DRUG
    Includes oxaliplatin, irinotecan, leucovorin, and 5-FU.

Study Details

The investigators hypothesize that MK2 inhibition may improve efficacy of mFOLFIRINOX chemotherapy for patients with pancreatic ductal adenocarcinoma (PDAC).

Key Dates

Start date
Jun 13, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
May 31, 2030

Study Design

Enrollment
51 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation phase (zunsemetinib + mFOLFIRNOX)
    The dose of zunsemetinib will be determined by the dose level assigned and will be taken by mouth either once or twice daily depending on assigned dose level. mFOLFIRINOX will be 85 mg/m\^2 of oxaliplatin intravenous (IV) on day 1 of each cycle, 150 mg/m\^2 of irinotecan IV on day 1 of each cycle, 400 mg/m\^2 of leucovorin IV on day 1 of each cycle, and 2400 mg/m\^2 continuous infusion starting on day 1 of each cycle and continuing for 46 hours. Each cycle is 2 weeks in length.
  • Experimental: Dose expansion phase (zunsemetinib + mFOLFIRNOX)
    The dose of zunsemetinib will be determined during the dose escalation phase of the trial. mFOLFIRINOX will be 85 mg/m\^2 of oxaliplatin intravenous (IV) on day 1 of each cycle, 150 mg/m\^2 of irinotecan IV on day 1 of each cycle, 400 mg/m\^2 of leucovorin IV on day 1 of each cycle, and 2400 mg/m\^2 continuous infusion starting on day 1 of each cycle and continuing for 46 hours. Each cycle is 2 weeks in length.

Primary Outcome Measure

Recommended phase II dose (RP2D) of zunsemetinib in combination with mFOLFIRINOX (Dose Escalation Only) [ Time Frame: Completion of 2 cycles (each cycle is 2 weeks - estimated to be 4 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Moh'd Khushman, M.D.
[email protected]
314-273-3564
Moh'd Khushman, M.D. (PRINCIPAL_INVESTIGATOR)
Nikolaos Andreatos, M.D. (SUB_INVESTIGATOR)
Olivia Aranha, M.D., Ph.D. (SUB_INVESTIGATOR)
Patrick Grierson, M.D., Ph.D. (SUB_INVESTIGATOR)
Ramon Jin, M.D., Ph.D. (SUB_INVESTIGATOR)
Kian-Huat Lim, M.D., Ph.D. (SUB_INVESTIGATOR)
Rama Suresh, M.D. (SUB_INVESTIGATOR)
Benjamin Tan, M.D. (SUB_INVESTIGATOR)
Nikolaos Trikalinos, M.D. (SUB_INVESTIGATOR)
Max Wattenberg, M.D. (SUB_INVESTIGATOR)
Esther Lu, Ph.D. (SUB_INVESTIGATOR)
Chunjie Li, M.D., Ph.D. (SUB_INVESTIGATOR)
Mark O'Hara, M.D. (SUB_INVESTIGATOR)

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