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NCT07166601RecruitingPhase 1

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

An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of M0324, a Bispecific (MUC-1 x CD40) Antibody as Monotherapy, in Combination With Pembrolizumab, and in Combination With Chemotherapy, in Participants With Selected Advanced Solid Tumors

Source: ClinicalTrials.gov · Last updated 2 Nov 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
77 (estimated)
First submitted
3 Sept 2025
Start date
10 Oct 2025
Primary completion date
23 Feb 2029
Lead sponsor
EMD Serono Research & Development Institute, Inc.
NCT number
NCT07166601

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 77
  • From 10 Oct 2025 to the primary completion date, 23 Feb 2029
  • 5 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Has a history of chronic diarrhea greater than or equal to (\>=) Grade 2, inflammatory disease of the colon or rectum, or unresolved partial or complete intestinal obstruction
  • Participant has a history of malignancy within 3 years before the date of enrollment
  • Uncontrolled or poorly controlled arterial hypertension, uncontrolled cardiac arrhythmia, unstable angina, myocardial infarction, congestive heart failure \[New York Heart Association (NYHA) \>= II\] or a coronary revascularization procedure within 180 days of study entry

Other

  • Life expectancy of less than 3 months
  • Other protocol defined exclusion criteria could apply.

Who the study is looking for

  • 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 not permitted
  • Other protocol defined inclusion criteria could apply.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Princess Margaret Cancer Centre
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
National Cancer Center Hospital
Coordinator of this site? Confirm its status
ChūōkuJapanRecruiting
Yale Cancer Center
Coordinator of this site? Confirm its status
New HavenUnited StatesRecruiting
Icahn School of Medicine at Mount Sinai
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
NEXT Oncology
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.