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RECRUITING
NCT07360314
PHASE1

Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors

Sponsor: EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

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

Interventions

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.

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