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

Merck KGaA (EMD Serono)

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Biological: M0324; Drug: mFOLFIRINOX; Biological: Pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07166601

MS201557_0009

Details and patient eligibility

About

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).

Enrollment: 77 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

77 participants in 3 patient groups

Part 1: M0324 Monotherapy

Experimental group

Treatment:

Biological: M0324

Biological: M0324

Part 2: M0324 + Pembrolizumab

Experimental group

Treatment:

Biological: Pembrolizumab

Biological: M0324

Biological: M0324

Part 3: M0324 + mFOLFIRINOX

Experimental group

Treatment:

Drug: mFOLFIRINOX

Biological: M0324

Biological: M0324