Clinical Trial

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

Study acronym: TITER
Recruiting Phase 1
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Summary
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).
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2025-09-03; most recent amendment 2026-07-15.
Status change: Not Yet Recruiting → Recruiting 2025-10-16
Trial Details
NCT Number NCT07166601
Lead Sponsor EMD Serono Research & Development Institute, Inc.
Collaborators: Merck KGaA, Darmstadt, Germany
Conditions Advanced Solid Tumor
Enrollment 77 participants
Start Date 2025-10-10
Primary Completion 2029-02-23 (estimated)
Study Completion 2029-02-23 (estimated)
Updated on ClinicalTrials.gov 2026-08-11