Skip to main content
Advanced Solid TumorsFirst-in-humanCancerWomen's healthDrugPhase 1

What this study is

The purpose of this first-in-human (FIH) study is to evaluate the safety, tolerability, Pharmacokinetics (PK), and preliminary clinical activity of M7437 in participants with locally advanced or metastatic solid tumors with known Ly6E expression, including non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), epithelial ovarian carcinoma (EOC), squamous cell carcinoma of the head and neck (SCCHN), pancreatic ductal adenocarcinoma (PDAC), and gastric cancer (GC).

What's being tested

  • M7437

    Intervention · DRUG

    Participants will receive M7437 as an intravenous infusion at a dose corresponding to their assigned cohort. Dose escalation will occur between cohorts, with 3-4 participants enrolled at each dose level before proceeding to the next higher dose.

  • M7437

    Intervention · DRUG

    Participants will receive M7437 at a dose that was determined as recommended dose for expansion (RDE) in Part 1.

Study details

Official title
A Phase 1, 2-Part, Multicenter, Open-Label, First-in-Human Study of the Anti-Ly6E Exatecan Antibody-Drug Conjugate M7437 in Participants With Advanced Solid Tumors
Sponsor
EMD Serono Research & Development Institute, Inc.
Conditions
Advanced Solid Tumors
Enrolling
138 people
Starts
2026-02-13
Est. completion
2029-03-28
Design
Open-label, non-randomized, sequential groups, Phase 1
Record
View on ClinicalTrials.gov ↗