Phase
Condition
N/ATreatment
mFOLFIRINOX
Pembrolizumab
M0324
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Part 1- M0324 Monotherapy:
• Participants with certain advanced/metastatic solid tumor types known to overexpress MUC-1 and who are intolerant or refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator
Part 2- M0324 Combination with Pembrolizumab:
• Participants with certain advanced/metastatic tumor types known to overexpress MUC-1 and the participants in the combination treatment involving M0324 and pembrolizumab must be intolerant or refractory to standard therapy and no other further standard therapy should be judged appropriate by the Investigator. In addition, the participants must have had prior treatment with immune checkpoint inhibitor(s) (ICIs) and must have experienced documented disease progression on or after ICIs.
Part 3- M0324 Combination with mFOLFIRINOX:
Participants with previously untreated metastatic pancreatic ductal adenocarcinoma,who are judged by Investigator as eligible for treatment with mFOLFIRINOX.Participants with prior Whipple surgery and/or adjuvant chemotherapy are notpermitted
Other protocol defined inclusion criteria could apply
Exclusion
Exclusion Criteria:
Has a history of chronic diarrhea greater than or equal to (>=) Grade 2,inflammatory disease of the colon or rectum, or unresolved partial or completeintestinal obstruction
Participant has a history of malignancy within 3 years before the date of enrollment
Uncontrolled or poorly controlled arterial hypertension, uncontrolled cardiacarrhythmia, unstable angina, myocardial infarction, congestive heart failure [NewYork Heart Association (NYHA) >= II] or a coronary revascularization procedurewithin 180 days of study entry
Life expectancy of less than 3 months
Other protocol defined exclusion criteria could apply
Study Design
Connect with a study center
Princess Margaret Cancer Centre
Toronto 6167865,
CanadaSite Not Available
Please Contact the Communication Center
Darmstadt 2938913, 64293
GermanySite Not Available
National Cancer Center Hospital
Chūōku 10262791,
JapanSite Not Available
Yale University School of Medicine
New Haven 4839366, Connecticut 4831725 06510
United StatesSite Not Available
Please Contact U.S. Medical Information
Rockland 4948924, Massachusetts 6254926 02370
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
United StatesSite Not Available
NEXT Oncology
San Antonio 4726206, Texas 4736286 78249
United StatesActive - Recruiting
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