M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors
NCT07166601
This study is recruiting at 3 US sites in 3 states, according to its ClinicalTrials.gov record last updated .
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).
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Advanced Solid Tumor
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 1
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- EMD Serono Research & Development Institute, Inc.
- Last updated on ClinicalTrials.gov
- October 7, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Connecticut · 1
- Yale Cancer Center · New Haven, CT
New York · 1
- Icahn School of Medicine at Mount Sinai · New York, NY
Texas · 1
- NEXT Oncology · San Antonio, TX
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.