OncoMatch/Clinical Trials/NCT07166601
M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors
Is NCT07166601 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including M0324 and M0324 for advanced solid tumor.
Treatment: M0324 · M0324 · Pembrolizumab · mFOLFIRINOX — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: MUC1 overexpression
Disease stage
Required: Stage IV
Metastatic disease required
advanced/metastatic solid tumor types
Prior therapy
Must have received: immune checkpoint inhibitor
must have had prior treatment with immune checkpoint inhibitor(s) (ICIs) and must have experienced documented disease progression on or after ICIs
Cannot have received: adjuvant chemotherapy
Participants with prior Whipple surgery and/or adjuvant chemotherapy are not permitted
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Yale University School of Medicine · New Haven, Connecticut
- Icahn School of Medicine at Mount Sinai · New York, New York
- NEXT Oncology · San Antonio, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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