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Study of M0324 for Advanced Solid Tumors

This study is testing a new treatment called M0324 for people with advanced solid tumors. Researchers want to find the safest and most effective dose of M0324, both alone and when combined with other treatments like pembrolizumab (a checkpoint inhibitor, which helps your immune system fight cancer) or mFOLFIRINOX chemotherapy. The study will enroll about 77 participants aged 18 and older. To join, you must have certain advanced solid tumors that overexpress MUC-1 and have not responded to standard treatments or for which no standard treatment is suitable. The main goal is to see how many participants experience side effects and how severe they are. The study is currently unclear on its recruitment status.

Study design
This is a first-in-human interventional study with an estimated enrollment of 77 participants. It is designed to test M0324 as a single treatment and in combination with other therapies.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-emergent adverse events for up to 40 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07166601

M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
EMD Serono Research & Development Institute, Inc.
~77 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:M0324PembrolizumabmFOLFIRINOX

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Parts 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)
Measured over Day 1 up to Day 21
+2 more outcomes measured

Conditions

Advanced Solid Tumor

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Where it's being run

5 sites across 5 states
Connecticut1
New York1
Texas1
Canada1
Japan1

Study leadership

  • Medical Responsible · STUDY_DIRECTOR · EMD Serono Research & Development Institute, Inc.

Who to contact

US Medical Information
[email protected]
888-275-7376
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • 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