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Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors
Sponsor: EMD Serono Research & Development Institute, Inc.
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).
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
138
Start Date
2026-02-13
Completion Date
2029-03-28
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
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.
M7437
Participants will receive M7437 at a dose that was determined as recommended dose for expansion (RDE) in Part 1.
Locations (8)
Yale University - Yale University School of Medicine
New Haven, Connecticut, United States
Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center
Huntersville, North Carolina, United States
NEXT Houston
Galveston, Texas, United States
NEXT Oncology - PARENT
San Antonio, Texas, United States
Princess Margaret Cancer Centre
Toronto, Canada
BC Cancer - Vancouver - BC Cancer Agency
Vancouver, Canada
National Cancer Center Hospital
Tokyo, Japan
NEXT Madrid - Hospital Universitario Quironsalud Madrid
Madrid, Spain