NCT07166601

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P75+ for phase_1

Timeline
34mo left

Started Oct 2025

Typical duration for phase_1

Geographic Reach
3 countries

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Oct 2025Feb 2029

First Submitted

Initial submission to the registry

September 3, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 10, 2025

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2029

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

3.4 years

First QC Date

September 3, 2025

Last Update Submit

April 22, 2026

Conditions

Advanced Solid Tumor

Keywords

Bispecific CD40 agonistic antibodyMucin-1 (MUC-1)pembrolizumabmFOLFIRINOXpancreatic ductal adenocarcinoma (PDAC)non-small cell lung cancer (NSCLC)

Outcome Measures

Primary Outcomes (3)

  • Parts 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)

    Day 1 up to Day 21

  • Part 1, 2 and 3: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

    Up to Month 40

  • Part 3: Number of Participants With Dose Limiting Toxicities (DLTs)

    Day 1 up to Day 35

Secondary Outcomes (8)

  • Parts 1 and 2: Pharmacokinetic (PK) Plasma Concentrations of M0324

    From Day 1 up to approximately 40 months

  • Parts 3: Pharmacokinetic (PK) Plasma Concentrations of M0324

    From Day 1 up to approximately 40 months

  • Percent Change from Baseline in Pharmacodynamic Markers

    From Day 1 up to approximately 40 months

  • Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator

    Time from first study treatment until progressive disease or death up to approximately 40 months

  • Progression-Free Survival (PFS) Time Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Time from first study treatment until first documentation of progressive disease (PD) or death, assessed approximately up to 40 months

  • +3 more secondary outcomes

Study Arms (3)

Part 1: M0324 Monotherapy

EXPERIMENTAL
Biological: M0324

Part 2: M0324 + Pembrolizumab

EXPERIMENTAL
Biological: M0324Biological: Pembrolizumab

Part 3: M0324 + mFOLFIRINOX

EXPERIMENTAL
Biological: M0324Drug: mFOLFIRINOX

Interventions

M0324BIOLOGICAL

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).

Part 1: M0324 Monotherapy
PembrolizumabBIOLOGICAL

Pembrolizumab will be administered intravenously as per standard of care.

Part 2: M0324 + Pembrolizumab
mFOLFIRINOXDRUG

mFOLFIRINOX will be administered intravenously as per standard of care.

Part 3: M0324 + mFOLFIRINOX

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

NOT YET RECRUITING

NEXT Oncology

San Antonio, Texas, 78249, United States

RECRUITING

Princess Margaret Cancer Centre

Toronto, Canada

RECRUITING

National Cancer Center Hospital

Chūōku, Japan

RECRUITING

Related Links

MeSH Terms

Conditions

Medullary cystic kidney disease 1Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Medical Responsible

    EMD Serono Research & Development Institute, Inc.

    STUDY DIRECTOR

Central Study Contacts

US Medical Information

CONTACT

888-275-7376eMediUSA@emdserono.com

Communication Center

CONTACT

+49 6151 72 5200service@emdgroup.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2025

First Posted

September 10, 2025

Study Start

October 10, 2025

Primary Completion (Estimated)

February 23, 2029

Study Completion (Estimated)

February 23, 2029

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or anew indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Locations

JP(1)CA(1)US(3)