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

Study acronym: TITER
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: EMD Serono Research & Development Institute, Inc. to EMD Serono Research & Development Institute, Inc. Eligibility criteria expanded, about 7 words · Secondary endpoints: details revised at 1 of 8 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 1 of 8 entries
  2. Re-verified, no change to tracked fieldsv14
  3. Study sites revised (5)v13 See this version in full on ClinicalTrials.gov ↗
  4. Re-verified, no change to tracked fieldsv12
  5. Site details revised at 1 of 5 sitesv11
Show 9 earlier versionsHide 9 earlier versions
  1. 2 versions Re-verified since Apr 22, 2026, no change to tracked fieldsv9-v10
  2. Site details revised at 1 of 5 sitesv8
  3. Site details revised at 1 of 5 sitesv7
  4. Re-verified, no change to tracked fieldsv6
  5. Site details revised at 1 of 5 sitesv5
  6. Re-verified, no change to tracked fieldsv4
  7. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 16, 2025 to Oct 10, 2025 · Site details revised at 5 of 5 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of Oct 16, 2025 to Oct 10, 2025
    • Site details revised at 5 of 5 sites
  8. Study sites: 2 to 5v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Merck KGaA
43 trials monitored
See 4 trials at risk
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).
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov