Actively Recruiting
M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors
Led by EMD Serono Research & Development Institute, Inc. · Updated on 2026-04-27
77
Participants Needed
5
Research Sites
176 weeks
Total Duration
On this page
Sponsors
E
EMD Serono Research & Development Institute, Inc.
Lead Sponsor
M
Merck KGaA, Darmstadt, Germany
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with advanced or metastatic solid tumors overexpressing MUC-1 intolerant or refractory to standard therapy or lacking appropriate standard therapy (Part 1)
- Participants with advanced/metastatic MUC-1 positive tumors intolerant or refractory to standard therapy, prior immune checkpoint inhibitor treatment with progression for M0324 plus pembrolizumab (Part 2)
- Participants with untreated metastatic pancreatic ductal adenocarcinoma eligible for mFOLFIRINOX without prior Whipple surgery or adjuvant chemotherapy (Part 3)
You will not qualify if you...
- History of chronic diarrhea Grade 2 or higher, inflammatory colon/rectal disease, or unresolved intestinal obstruction
- History of malignancy within 3 years prior to enrollment
- Uncontrolled or poorly controlled heart conditions including hypertension, arrhythmia, unstable angina, myocardial infarction, congestive heart failure (NYHA II or higher), or recent coronary revascularization within 180 days
- Life expectancy less than 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Not Yet Recruiting
3
NEXT Oncology
San Antonio, Texas, United States, 78249
Actively Recruiting
4
Princess Margaret Cancer Centre
Toronto, Canada
Actively Recruiting
5
National Cancer Center Hospital
Chūōku, Japan
Actively Recruiting
Research Team
U
US Medical Information
CONTACT
C
Communication Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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