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RECRUITING
NCT07166601
PHASE1

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

Sponsor: EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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).

BIOLOGICAL

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.

BIOLOGICAL

Pembrolizumab

Pembrolizumab will be administered intravenously as per standard of care.

DRUG

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