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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
EMD Serono Research & Development Institute, Inc.
Study ID
NCT07166601
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • M0324 — BIOLOGICAL
    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 — BIOLOGICAL
    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 — BIOLOGICAL
    Pembrolizumab will be administered intravenously as per standard of care.
  • mFOLFIRINOX — DRUG
    mFOLFIRINOX will be administered intravenously as per standard of care.

Study Details

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).

Key Dates

Start date
Oct 10, 2025
Status verified
May 2026
Primary completion
Feb 23, 2029
Completion
Feb 23, 2029

Study Design

Enrollment
77 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: M0324 Monotherapy
  • Experimental: Part 2: M0324 + Pembrolizumab
  • Experimental: Part 3: M0324 + mFOLFIRINOX

Primary Outcome Measure

Parts 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Day 1 up to Day 21 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Yale University School of MedicineNew HavenConnecticut06510-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
NEXT OncologySan AntonioTexas78249-

Find similar trials in New Haven, CT

By research site
Yale University School of Medicine· New Haven, CTIcahn School of Medicine at Mount Sinai· New York, NYNEXT Oncology· San Antonio, TX

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