M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors

Last updated: November 13, 2025
Sponsor: EMD Serono Research & Development Institute, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

mFOLFIRINOX

Pembrolizumab

M0324

Clinical Study ID

NCT07166601
MS201557_0009
  • Ages > 18
  • All Genders

Study Summary

The purpose of this first-in-human study is to identify a recommend dose(s) for subsequent larger studies (recommended dose(s) for expansion, RDE), examining increasing doses of M0324, primarily looking at safety, but also preliminary signs of efficacy, pharmacokinetics (PK), and pharmacodynamics (PD). Three different treatments with M0324 will be studied, M0324 as a monotherapy (Part 1), M0324 in combination with pembrolizumab (Part 2), and in combination with mFOLFIRINOX (a chemotherapy treatment) (Part 3).

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

Total Participants: 77
Treatment Group(s): 3
Primary Treatment: mFOLFIRINOX
Phase: 1
Study Start date:
October 10, 2025
Estimated Completion Date:
February 23, 2029

Connect with a study center

  • Princess Margaret Cancer Centre

    Toronto 6167865,
    Canada

    Site Not Available

  • Please Contact the Communication Center

    Darmstadt 2938913, 64293
    Germany

    Site Not Available

  • National Cancer Center Hospital

    Chūōku 10262791,
    Japan

    Site Not Available

  • Yale University School of Medicine

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Site Not Available

  • Please Contact U.S. Medical Information

    Rockland 4948924, Massachusetts 6254926 02370
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • NEXT Oncology

    San Antonio 4726206, Texas 4736286 78249
    United States

    Active - Recruiting

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