M0324 alone or with pembrolizumab or mFOLFIRINOX chemotherapy for selected advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, phase 1 dose-escalation trial is studying increasing doses of M0324 as monotherapy and in two combination arms (with pembrolizumab and with mFOLFIRINOX) to identify recommended dose(s) for expansion. The primary focus is safety and tolerability, with secondary assessments of pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity. Part 1 enrolls patients with selected MUC-1–expressing advanced solid tumors refractory or intolerant to standard therapies; Part 2 enrolls similar patients who have progressed after prior immune checkpoint inhibitors; Part 3 enrolls patients with previously untreated metastatic pancreatic ductal adenocarcinoma eligible for mFOLFIRINOX. Dose escalation findings will determine doses and cohorts for later expansion.

Why it matters

Who can join: the full rules

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.

Where it's running

• Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• Icahn School of Medicine at Mount Sinai
  New York, New York, United States Recruiting
• NEXT Oncology
  San Antonio, Texas, United States Recruiting
• Princess Margaret Cancer Centre
  Toronto, Canada Recruiting
• National Cancer Center Hospital
  Chūōku, Japan Recruiting

Study contacts

• Study coordinator: US Medical Information
• Email: eMediUSA@emdserono.com
• Phone: 888-275-7376

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.