Advanced Solid TumorPhase 1TITERNCT07166601
M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors
A Phase 1 study testing M0324, Pembrolizumab and mFOLFIRINOX in people with Advanced Solid Tumor, run by EMD Serono Research & Development Institute, Inc. at 5 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- M0324, Pembrolizumab and mFOLFIRINOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 10 Oct 2025to 23 Feb 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 3 countries
United States3 sites, 3 recruiting
- Recruiting
Yale Cancer Center
New Haven, Connecticut, 06511
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
- Recruiting
NEXT Oncology
San Antonio, Texas, 78249
About this study
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
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
- Being tested
- M0324, Pembrolizumab, mFOLFIRINOX
- Keywords
- Bispecific CD40 agonistic antibody, Mucin-1 (MUC-1), pembrolizumab, mFOLFIRINOX, pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC)
- Medical subject headings
- Medullary cystic kidney disease 1, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
M0324Biological
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.
PembrolizumabBiological
Pembrolizumab will be administered intravenously as per standard of care.
mFOLFIRINOXDrug
mFOLFIRINOX will be administered intravenously as per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: M0324 Monotherapy | Experimental | Not described Receives: Biological: M0324 |
| Part 2: M0324 + Pembrolizumab | Experimental | Not described Receives: Biological: M0324; Biological: Pembrolizumab |
| Part 3: M0324 + mFOLFIRINOX | Experimental | Not described Receives: Biological: M0324; Drug: mFOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)
Measured: Day 1 up to Day 21
Part 1, 2 and 3: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to Month 40
Part 3: Number of Participants With Dose Limiting Toxicities (DLTs)
Measured: Day 1 up to Day 35
Secondary outcomes (8)
Parts 1 and 2: Pharmacokinetic (PK) Plasma Concentrations of M0324
Measured: From Day 1 up to approximately 40 months
Parts 3: Pharmacokinetic (PK) Plasma Concentrations of M0324
Measured: From Day 1 up to approximately 40 months
Percent Change from Baseline in Pharmacodynamic Markers
Pharmacodynamic and circulating biomarkers (e.g. cytokines) will be measured in blood.
Measured: 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
Measured: 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
Measured: Time from first study treatment until first documentation of progressive disease (PD) or death, assessed approximately up to 40 months
Duration of Response (DoR) According to RECIST v1.1 as Assessed by Investigator
Measured: Time from first documentation of OR until progressive disease (PD) or death, assessed approximately up to 40 months
Part 3: Overall Survival (OS)
Measured: Time from first study treatment until death, assessed approximately up to 40 months
Number of Participants With Positive Anti-Drug Antibody (ADA) of M0324
Measured: Up to Month 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start10 Oct 2025
- Primary completion23 Feb 2029 (estimated)
- Study completion23 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by EMD Serono Research & Development Institute, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, EMD Serono Research & Development Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166601
- Sponsor's protocol ID
- MS201557_0009
- Other IDs
- jRCT2031250509
- Acronym
- TITER
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared for Phase I interventional or observational studies. Further information on how to request data can be found on our website bit.ly/IPD21.