RecruitingPhase 1NCT07166601

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


Sponsor

EMD Serono Research & Development Institute, Inc.

Enrollment

77 participants

Start Date

Oct 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called M0324, alone and in combination with pembrolizumab (an immunotherapy drug) or chemotherapy, in people with advanced solid tumors whose cancer overexpresses a protein called MUC-1. MUC-1 is found on many cancer types and M0324 is designed to target it. **You may be eligible if...** - You have an advanced or metastatic solid tumor known to overexpress MUC-1 (such as certain lung, breast, ovarian, or colon cancers) - Your cancer no longer responds to standard treatments, or no standard options exist - For the combination therapy arms: you must have had prior immunotherapy and experienced cancer progression - You are in adequate overall health **You may NOT be eligible if...** - You have not tried standard treatments that are available and appropriate for you - You have active autoimmune disease requiring treatment - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALM0324

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).

BIOLOGICALM0324

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.

BIOLOGICALPembrolizumab

Pembrolizumab will be administered intravenously as per standard of care.

DRUGmFOLFIRINOX

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

View Full Details on ClinicalTrials.gov

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NCT07166601


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