Actively Recruiting
Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors
Led by EMD Serono Research & Development Institute, Inc. · Updated on 2026-04-21
138
Participants Needed
9
Research Sites
162 weeks
Total Duration
On this page
Sponsors
E
EMD Serono Research & Development Institute, Inc.
Lead Sponsor
M
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older with histologically confirmed advanced solid tumors that express high levels of Ly6E
- Tumors must be unresectable, locally advanced, or metastatic and refractory to or without standard therapies
- Participants with non-small cell lung cancer, triple-negative breast cancer, squamous cell carcinoma of the head and neck, pancreatic ductal adenocarcinoma, gastric cancer, or epithelial ovarian cancer
- ECOG Performance Status of 0 or 1
- Blood, liver, and kidney function within safe limits as defined by the protocol
- Other protocol-defined inclusion criteria may apply
You will not qualify if you...
- History of another malignancy within 3 years before enrollment, except certain skin cancers, carcinoma in situ of the cervix, benign prostate neoplasm/hyperplasia, or malignancy considered cured with minimal risk
- History of hematopoietic allogenic transplantation
- Known brain metastases unless all are treated, stable for at least 4 weeks, and without ongoing neurological symptoms related to brain disease
- Diarrhea (liquid stool) or ileus greater than Grade 1 within 1 week before treatment start
- Active chronic inflammatory bowel disease or bowel obstruction
- History of serious gastrointestinal bleeding within 3 months before treatment
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Yale University - Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Not Yet Recruiting
2
Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center
Huntersville, North Carolina, United States, 28078
Not Yet Recruiting
3
NEXT Houston
Galveston, Texas, United States, 77001
Actively Recruiting
4
NEXT Oncology - PARENT
San Antonio, Texas, United States, 78229
Actively Recruiting
5
Princess Margaret Cancer Centre
Toronto, Canada
Actively Recruiting
6
BC Cancer - Vancouver - BC Cancer Agency
Vancouver, Canada
Not Yet Recruiting
7
National Cancer Center Hospital
Tokyo, Japan
Actively Recruiting
8
Hospital Universitari Vall d'Hebron - VHIO - Oncology - Phase I Unit
Barcelona, Spain, 08035
Not Yet Recruiting
9
NEXT Madrid - Hospital Universitario Quironsalud Madrid
Madrid, Spain
Not Yet Recruiting
Research Team
U
US Medical Information
CONTACT
C
Communication Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
2
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