RightFit
RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests M0324 alone, with pembrolizumab, or with chemotherapy called mFOLFIRINOX in people with certain advanced cancers. It is the first study of M0324 in humans and aims to find safe doses for larger studies and early signs that it works.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • For M0324 alone: You must have a certain advanced or spreading solid cancer type known to make high levels of a protein called MUC-1.
  • For M0324 alone: Standard treatment must not work, cause side effects you cannot tolerate, or be judged unsuitable by the study doctor.
  • For M0324 with pembrolizumab: You must have a certain advanced or spreading cancer type known to make high levels of MUC-1.
  • For M0324 with pembrolizumab: Standard treatment must not work or cause side effects you cannot tolerate, and the study doctor must judge that no further standard treatment is suitable.
  • For M0324 with pembrolizumab: You must have had immune checkpoint inhibitors, drugs that help the immune system fight cancer. Records must show your cancer got worse during or after this treatment.
  • For M0324 with chemotherapy: You must have pancreatic ductal adenocarcinoma, a type of pancreatic cancer, that has spread and has not been treated. The study doctor must decide that you can receive mFOLFIRINOX.
  • For M0324 with chemotherapy: You cannot have had Whipple surgery, an operation for pancreatic cancer, or chemotherapy given after surgery.
  • Other study rules may apply.

Who can't join

  • A history of long-lasting diarrhea rated grade 2 or higher, meaning at least moderate in severity.
  • Inflammation of the colon or rectum, or a partly or fully blocked intestine that has not cleared.
  • A history of cancer within 3 years before joining the study.
  • Uncontrolled or poorly controlled high blood pressure, or an uncontrolled irregular heartbeat.
  • Unstable angina (chest pain), a heart attack, heart failure rated NYHA class II or higher, or a procedure to restore blood flow to the heart within 180 days before joining.
  • Expected to live less than 3 months.
  • Other study rules may apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (3)

CT

NY

TX