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
- Are there results?
- Not yet: the study is under way
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
- 2 Nov 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07166601
- Acronym / sponsor ID
- TITER / MS201557_0009
- Conditions
- Advanced Solid Tumor
- Keywords
- Bispecific CD40 agonistic antibody, Mucin-1 (MUC-1), pembrolizumab, mFOLFIRINOX, pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 23 Feb 2029 (estimated)
- Study completion
- 23 Feb 2029 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: M0324 Monotherapy | Experimental | Biological: M0324 |
| Part 2: M0324 + Pembrolizumab | Experimental | Biological: M0324, Biological: Pembrolizumab |
| Part 3: M0324 + mFOLFIRINOX | Experimental | Biological: M0324, Drug: mFOLFIRINOX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- 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.
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M0324M0324 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 | Part 1: M0324 Monotherapy |
| M0324M0324 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 | Part 2: M0324 + Pembrolizumab, Part 3: M0324 + mFOLFIRINOX |
| PembrolizumabPembrolizumab will be administered intravenously as per standard of care. | Biological | Part 2: M0324 + Pembrolizumab |
| mFOLFIRINOXmFOLFIRINOX will be administered intravenously as per standard of care. | Drug | Part 3: M0324 + mFOLFIRINOX |
Primary outcome
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
8 secondary outcomes
Parts 1 and 2: Pharmacokinetic (PK) Plasma Concentrations of M0324
Time frame: From Day 1 up to approximately 40 months
Parts 3: Pharmacokinetic (PK) Plasma Concentrations of M0324
Time frame: From Day 1 up to approximately 40 months
Percent Change from Baseline in Pharmacodynamic Markers
Time frame: 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 frame: 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 frame: 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
Time frame: Time from first documentation of OR until progressive disease (PD) or death, assessed approximately up to 40 months
Part 3: Overall Survival (OS)
Time frame: Time from first study treatment until death, assessed approximately up to 40 months
Number of Participants With Positive Anti-Drug Antibody (ADA) of M0324
Time frame: Up to Month 40
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- US Medical Information website, Medical ResourcesLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Responsible study director
EMD Serono Research & Development Institute, Inc.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US Medical Information (888-275-7376, eMediUSA@emdserono.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parts 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: Day 1 up to Day 21). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.