NCT07360314

Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Advanced Solid Tumors

Interventions

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

Timeline

• Start date: 2026-02-13
• Primary completion: 2028-09-20
• Completion: 2029-03-28
• First posted: 2026-01-22
• Last updated: 2026-03-25

Locations

8 sites across 4 countries: United States, Canada, Japan, Spain

Regulatory

• FDA-regulated drug study