M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
M0324: M0324 will be tested at increasing doses as monotherapy to determine dose-toxicity relationship and MTD (if reached) in order to support selection of recommended dose(s) for expansion (RDE).
M0324: M0324 will be further investigated in part 2 and part 3 of the study as combination regimen, in order to determine dose-toxicity relationship in combination and MTD (if reached) in order to support selection of RDE(s) in combination.
Pembrolizumab: Pembrolizumab will be administered intravenously as per standard of care.
mFOLFIRINOX: mFOLFIRINOX will be administered intravenously as per standard of care.
Study 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).
Eligibility
Primary outcome measure(s)
- Parts 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs) — Day 1 up to Day 21
- Part 1, 2 and 3: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) — Up to Month 40
- Part 3: Number of Participants With Dose Limiting Toxicities (DLTs) — Day 1 up to Day 35
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Yale Cancer Center | New Haven | Connecticut | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | Recruiting |
| NEXT Oncology | San Antonio | Texas | Recruiting |
| Princess Margaret Cancer Centre | Toronto | Canada | Recruiting |
| National Cancer Center Hospital | Chūōku | Japan | Recruiting |
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07166601 on ClinicalTrials.gov ↗ ← All trials in the USA