Overview

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

Status:
NOT_YET_RECRUITING

Trial end date:
2029-02-23

Target enrollment:

Participant gender:

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).

Phase:

PHASE1

Details

Lead Sponsor:

EMD Serono Research & Development Institute, Inc.

Collaborator:

Merck KGaA, Darmstadt, Germany

Treatments:

pembrolizumab