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M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors
Sponsor: EMD Serono Research & Development Institute, Inc.
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
77
Start Date
2025-10-10
Completion Date
2029-02-23
Last Updated
2026-02-18
Healthy Volunteers
No
Conditions
Interventions
M0324
M0324 will be tested at increasing doses as monotherapy to determine dose-toxicity relationship and MTD (if reached) in order to support selection of recommended dose(s) for expansion (RDE).
M0324
M0324 will be further investigated in part 2 and part 3 of the study as combination regimen, in order to determine dose-toxicity relationship in combination and MTD (if reached) in order to support selection of RDE(s) in combination.
Pembrolizumab
Pembrolizumab will be administered intravenously as per standard of care.
mFOLFIRINOX
mFOLFIRINOX will be administered intravenously as per standard of care.
Locations (5)
Yale University School of Medicine
New Haven, Connecticut, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
NEXT Oncology
San Antonio, Texas, United States
Princess Margaret Cancer Centre
Toronto, Canada
National Cancer Center Hospital
Chūōku, Japan