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NCT Number: NCT07166601

M0324 as Monotherapy and in Combination With Pembrolizumab or 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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Princess Margaret Cancer Centre, Toronto, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

M0324

Biological

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).

Pembrolizumab

Biological

Pembrolizumab will be administered intravenously as per standard of care.

mFOLFIRINOX

Drug

mFOLFIRINOX will be administered intravenously as per standard of care.

Primary outcomes

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

    Time frame: Day 1 up to Day 21

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

    Time frame: Up to Month 40

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

    Time frame: Day 1 up to Day 35

Secondary outcomes

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

    Time frame: From Day 1 up to approximately 40 months

  2. Parts 3: Pharmacokinetic (PK) Plasma Concentrations of M0324

    Time frame: From Day 1 up to approximately 40 months

  3. Percent Change from Baseline in Pharmacodynamic Markers

    Time frame: From Day 1 up to approximately 40 months

    Pharmacodynamic and circulating biomarkers (e.g. cytokines) will be measured in blood.

  4. 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

  5. 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

  6. 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

  7. Part 3: Overall Survival (OS)

    Time frame: Time from first study treatment until death, assessed approximately up to 40 months

  8. Number of Participants With Positive Anti-Drug Antibody (ADA) of M0324

    Time frame: Up to Month 40

Study contacts

Contact information is provided by the study sponsor or research team.

Communication Center

CONTACT

[email protected]

+49 6151 72 5200

US Medical Information

CONTACT

[email protected]

888-275-7376

Sponsors and collaborators

Lead sponsor

EMD Serono Research & Development Institute, Inc.

Industry

Collaborators

  • Merck KGaA, Darmstadt, Germany

Registry information

Official study 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

Acronym: TITER

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Sep 10, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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