Recruiting
Phase 1

M0324, Pembrolizumab, mFOLFIRINOX

Sponsor:

EMD Serono Research & Development Institute, Inc.

Code:

NCT07166601

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

M0324

M0324

Pembrolizumab

mFOLFIRINOX

Study Details

Brief 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).

Conditions

Advanced Solid Tumor

Study ID

NCT07166601

Start date

Oct 10, 2025

Status verified date

Aug, 2026

Completion date

Feb 23, 2029

Anticipated

Primary completion date

Feb 23, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

77 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: M0324 Monotherapy

experimental: Part 2: M0324 + Pembrolizumab

experimental: Part 3: M0324 + mFOLFIRINOX

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.

Primary outcome measure

  • Parts 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Day 1 up to Day 21 ]
  • Part 1, 2 and 3: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Month 40 ]
  • Part 3: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Day 1 up to Day 35 ]

Central Contacts and Locations

Central contacts

Locations

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06511

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78249

Princess Margaret Cancer Centre

Recruiting

Toronto, Canada

More Information

Sponsor

EMD Serono Research & Development Institute, Inc.

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • Bispecific CD40 agonistic antibody
  • Mucin-1 (MUC-1)
  • pembrolizumab
  • mFOLFIRINOX
  • pancreatic ductal adenocarcinoma (PDAC)
  • non-small cell lung cancer (NSCLC)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by EMD Serono Research & Development Institute, Inc. on 2026-08-11.