MK2 Inhibitor + mFOLFIRINOX for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

Overseen byMoh'd Khushman

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Research Team

Moh'd Khushman

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for individuals with untreated metastatic pancreatic ductal adenocarcinoma. Participants should not have had previous treatments for their condition.

Inclusion Criteria

Ability to understand and willingness to sign an IRB approved written informed consent document.

I agree to use birth control if I can have children or am sexually active with women who can.

Measurable disease by RECIST 1.1.

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Exclusion Criteria

I have lung disease that causes symptoms like coughing or shortness of breath.

I cannot swallow pills.

I have taken specific drugs that affect how my body processes other medications.

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Treatment Details

Interventions

mFOLFIRINOX (Chemotherapy)
Zunsemetinib (Kinase Inhibitor)

Trial OverviewThe study tests the combination of a new drug, Zunsemetinib (MK2 inhibitor), with an existing chemotherapy regimen called mFOLFIRINOX to see if it's more effective in treating pancreatic cancer.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Dose expansion phase (zunsemetinib + mFOLFIRNOX)Experimental Treatment2 Interventions

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.

Group II: Dose escalation phase (zunsemetinib + mFOLFIRNOX)Experimental Treatment2 Interventions

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.

mFOLFIRINOX is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as mFOLFIRINOX for: