Clinical Trial

Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors

Recruiting Phase 1
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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).
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2026-01-13; most recent amendment 2026-07-15.
Status change: Not Yet Recruiting → Recruiting 2026-02-26
Trial Details
NCT Number NCT07360314
Lead Sponsor EMD Serono Research & Development Institute, Inc.
Collaborators: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Conditions Advanced Solid Tumors
Enrollment 138 participants
Start Date 2026-02-13
Primary Completion 2028-09-20 (estimated)
Study Completion 2029-03-28 (estimated)
Updated on ClinicalTrials.gov 2026-07-17